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Showing 1 - 200 of 3175 Journals sorted alphabetically
A Practical Logic of Cognitive Systems     Full-text available via subscription   (Followers: 9)
AASRI Procedia     Open Access   (Followers: 14)
Academic Pediatrics     Hybrid Journal   (Followers: 28, SJR: 1.402, h-index: 51)
Academic Radiology     Hybrid Journal   (Followers: 22, SJR: 1.008, h-index: 75)
Accident Analysis & Prevention     Partially Free   (Followers: 90, SJR: 1.109, h-index: 94)
Accounting Forum     Hybrid Journal   (Followers: 25, SJR: 0.612, h-index: 27)
Accounting, Organizations and Society     Hybrid Journal   (Followers: 33, SJR: 2.515, h-index: 90)
Achievements in the Life Sciences     Open Access   (Followers: 5)
Acta Anaesthesiologica Taiwanica     Open Access   (Followers: 6, SJR: 0.338, h-index: 19)
Acta Astronautica     Hybrid Journal   (Followers: 376, SJR: 0.726, h-index: 43)
Acta Automatica Sinica     Full-text available via subscription   (Followers: 2)
Acta Biomaterialia     Hybrid Journal   (Followers: 27, SJR: 2.02, h-index: 104)
Acta Colombiana de Cuidado Intensivo     Full-text available via subscription   (Followers: 2)
Acta de Investigación Psicológica     Open Access   (Followers: 3)
Acta Ecologica Sinica     Open Access   (Followers: 8, SJR: 0.172, h-index: 29)
Acta Haematologica Polonica     Free   (Followers: 1, SJR: 0.123, h-index: 8)
Acta Histochemica     Hybrid Journal   (Followers: 3, SJR: 0.604, h-index: 38)
Acta Materialia     Hybrid Journal   (Followers: 235, SJR: 3.683, h-index: 202)
Acta Mathematica Scientia     Full-text available via subscription   (Followers: 5, SJR: 0.615, h-index: 21)
Acta Mechanica Solida Sinica     Full-text available via subscription   (Followers: 9, SJR: 0.442, h-index: 21)
Acta Oecologica     Hybrid Journal   (Followers: 10, SJR: 0.915, h-index: 53)
Acta Otorrinolaringologica (English Edition)     Full-text available via subscription  
Acta Otorrinolaringológica Española     Full-text available via subscription   (Followers: 2, SJR: 0.311, h-index: 16)
Acta Pharmaceutica Sinica B     Open Access   (Followers: 1)
Acta Poética     Open Access   (Followers: 4)
Acta Psychologica     Hybrid Journal   (Followers: 25, SJR: 1.365, h-index: 73)
Acta Sociológica     Open Access  
Acta Tropica     Hybrid Journal   (Followers: 6, SJR: 1.059, h-index: 77)
Acta Urológica Portuguesa     Open Access  
Actas Dermo-Sifiliograficas     Full-text available via subscription   (Followers: 3)
Actas Dermo-Sifiliográficas (English Edition)     Full-text available via subscription   (Followers: 2)
Actas Urológicas Españolas     Full-text available via subscription   (Followers: 3, SJR: 0.383, h-index: 19)
Actas Urológicas Españolas (English Edition)     Full-text available via subscription   (Followers: 1)
Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 6, SJR: 0.141, h-index: 3)
Actualites Pharmaceutiques Hospitalieres     Full-text available via subscription   (Followers: 3, SJR: 0.112, h-index: 2)
Acupuncture and Related Therapies     Hybrid Journal   (Followers: 6)
Acute Pain     Full-text available via subscription   (Followers: 14)
Ad Hoc Networks     Hybrid Journal   (Followers: 11, SJR: 0.967, h-index: 57)
Addictive Behaviors     Hybrid Journal   (Followers: 15, SJR: 1.514, h-index: 92)
Addictive Behaviors Reports     Open Access   (Followers: 7)
Additive Manufacturing     Hybrid Journal   (Followers: 9, SJR: 1.039, h-index: 5)
Additives for Polymers     Full-text available via subscription   (Followers: 22)
Advanced Cement Based Materials     Full-text available via subscription   (Followers: 3)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 130, SJR: 5.2, h-index: 222)
Advanced Engineering Informatics     Hybrid Journal   (Followers: 11, SJR: 1.265, h-index: 53)
Advanced Powder Technology     Hybrid Journal   (Followers: 16, SJR: 0.739, h-index: 33)
Advances in Accounting     Hybrid Journal   (Followers: 8, SJR: 0.299, h-index: 15)
Advances in Agronomy     Full-text available via subscription   (Followers: 12, SJR: 2.071, h-index: 82)
Advances in Anesthesia     Full-text available via subscription   (Followers: 27, SJR: 0.169, h-index: 4)
Advances in Antiviral Drug Design     Full-text available via subscription   (Followers: 2)
Advances in Applied Mathematics     Full-text available via subscription   (Followers: 10, SJR: 1.054, h-index: 35)
Advances in Applied Mechanics     Full-text available via subscription   (Followers: 10, SJR: 0.801, h-index: 26)
Advances in Applied Microbiology     Full-text available via subscription   (Followers: 22, SJR: 1.286, h-index: 49)
Advances In Atomic, Molecular, and Optical Physics     Full-text available via subscription   (Followers: 14, SJR: 3.31, h-index: 42)
Advances in Biological Regulation     Hybrid Journal   (Followers: 4, SJR: 2.277, h-index: 43)
Advances in Botanical Research     Full-text available via subscription   (Followers: 2, SJR: 0.619, h-index: 48)
Advances in Cancer Research     Full-text available via subscription   (Followers: 28, SJR: 2.215, h-index: 78)
Advances in Carbohydrate Chemistry and Biochemistry     Full-text available via subscription   (Followers: 7, SJR: 0.9, h-index: 30)
Advances in Catalysis     Full-text available via subscription   (Followers: 5, SJR: 2.139, h-index: 42)
Advances in Cell Aging and Gerontology     Full-text available via subscription   (Followers: 3)
Advances in Cellular and Molecular Biology of Membranes and Organelles     Full-text available via subscription   (Followers: 12)
Advances in Chemical Engineering     Full-text available via subscription   (Followers: 27, SJR: 0.183, h-index: 23)
Advances in Child Development and Behavior     Full-text available via subscription   (Followers: 10, SJR: 0.665, h-index: 29)
Advances in Chronic Kidney Disease     Full-text available via subscription   (Followers: 10, SJR: 1.268, h-index: 45)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 28, SJR: 0.938, h-index: 33)
Advances in Colloid and Interface Science     Full-text available via subscription   (Followers: 19, SJR: 2.314, h-index: 130)
Advances in Computers     Full-text available via subscription   (Followers: 14, SJR: 0.223, h-index: 22)
Advances in Dermatology     Full-text available via subscription   (Followers: 14)
Advances in Developmental Biology     Full-text available via subscription   (Followers: 10)
Advances in Digestive Medicine     Open Access   (Followers: 8)
Advances in DNA Sequence-Specific Agents     Full-text available via subscription   (Followers: 5)
Advances in Drug Research     Full-text available via subscription   (Followers: 21)
Advances in Ecological Research     Full-text available via subscription   (Followers: 42, SJR: 3.25, h-index: 43)
Advances in Engineering Software     Hybrid Journal   (Followers: 27, SJR: 0.486, h-index: 10)
Advances in Experimental Biology     Full-text available via subscription   (Followers: 6)
Advances in Experimental Social Psychology     Full-text available via subscription   (Followers: 42, SJR: 5.465, h-index: 64)
Advances in Exploration Geophysics     Full-text available via subscription   (Followers: 1)
Advances in Fluorine Science     Full-text available via subscription   (Followers: 7)
Advances in Food and Nutrition Research     Full-text available via subscription   (Followers: 54, SJR: 0.674, h-index: 38)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 15)
Advances in Genetics     Full-text available via subscription   (Followers: 14, SJR: 2.558, h-index: 54)
Advances in Genome Biology     Full-text available via subscription   (Followers: 7)
Advances in Geophysics     Full-text available via subscription   (Followers: 6, SJR: 2.325, h-index: 20)
Advances in Heat Transfer     Full-text available via subscription   (Followers: 21, SJR: 0.906, h-index: 24)
Advances in Heterocyclic Chemistry     Full-text available via subscription   (Followers: 9, SJR: 0.497, h-index: 31)
Advances in Human Factors/Ergonomics     Full-text available via subscription   (Followers: 23)
Advances in Imaging and Electron Physics     Full-text available via subscription   (Followers: 1, SJR: 0.396, h-index: 27)
Advances in Immunology     Full-text available via subscription   (Followers: 36, SJR: 4.152, h-index: 85)
Advances in Inorganic Chemistry     Full-text available via subscription   (Followers: 8, SJR: 1.132, h-index: 42)
Advances in Insect Physiology     Full-text available via subscription   (Followers: 2, SJR: 1.274, h-index: 27)
Advances in Integrative Medicine     Hybrid Journal   (Followers: 6)
Advances in Intl. Accounting     Full-text available via subscription   (Followers: 3)
Advances in Life Course Research     Hybrid Journal   (Followers: 8, SJR: 0.764, h-index: 15)
Advances in Lipobiology     Full-text available via subscription   (Followers: 1)
Advances in Magnetic and Optical Resonance     Full-text available via subscription   (Followers: 9)
Advances in Marine Biology     Full-text available via subscription   (Followers: 14, SJR: 1.645, h-index: 45)
Advances in Mathematics     Full-text available via subscription   (Followers: 10, SJR: 3.261, h-index: 65)
Advances in Medical Sciences     Hybrid Journal   (Followers: 6, SJR: 0.489, h-index: 25)
Advances in Medicinal Chemistry     Full-text available via subscription   (Followers: 5)
Advances in Microbial Physiology     Full-text available via subscription   (Followers: 4, SJR: 1.44, h-index: 51)
Advances in Molecular and Cell Biology     Full-text available via subscription   (Followers: 21)
Advances in Molecular and Cellular Endocrinology     Full-text available via subscription   (Followers: 8)
Advances in Molecular Toxicology     Full-text available via subscription   (Followers: 7, SJR: 0.324, h-index: 8)
Advances in Nanoporous Materials     Full-text available via subscription   (Followers: 3)
Advances in Oncobiology     Full-text available via subscription   (Followers: 1)
Advances in Organ Biology     Full-text available via subscription   (Followers: 1)
Advances in Organometallic Chemistry     Full-text available via subscription   (Followers: 15, SJR: 2.885, h-index: 45)
Advances in Parallel Computing     Full-text available via subscription   (Followers: 6, SJR: 0.148, h-index: 11)
Advances in Parasitology     Full-text available via subscription   (Followers: 5, SJR: 2.37, h-index: 73)
Advances in Pediatrics     Full-text available via subscription   (Followers: 24, SJR: 0.4, h-index: 28)
Advances in Pharmaceutical Sciences     Full-text available via subscription   (Followers: 10)
Advances in Pharmacology     Full-text available via subscription   (Followers: 15, SJR: 1.718, h-index: 58)
Advances in Physical Organic Chemistry     Full-text available via subscription   (Followers: 8, SJR: 0.384, h-index: 26)
Advances in Phytomedicine     Full-text available via subscription  
Advances in Planar Lipid Bilayers and Liposomes     Full-text available via subscription   (Followers: 3, SJR: 0.248, h-index: 11)
Advances in Plant Biochemistry and Molecular Biology     Full-text available via subscription   (Followers: 7)
Advances in Plant Pathology     Full-text available via subscription   (Followers: 5)
Advances in Porous Media     Full-text available via subscription   (Followers: 5)
Advances in Protein Chemistry     Full-text available via subscription   (Followers: 17)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 18, SJR: 1.5, h-index: 62)
Advances in Psychology     Full-text available via subscription   (Followers: 59)
Advances in Quantum Chemistry     Full-text available via subscription   (Followers: 6, SJR: 0.478, h-index: 32)
Advances in Radiation Oncology     Open Access  
Advances in Small Animal Medicine and Surgery     Hybrid Journal   (Followers: 3, SJR: 0.1, h-index: 2)
Advances in Space Biology and Medicine     Full-text available via subscription   (Followers: 5)
Advances in Space Research     Full-text available via subscription   (Followers: 374, SJR: 0.606, h-index: 65)
Advances in Structural Biology     Full-text available via subscription   (Followers: 5)
Advances in Surgery     Full-text available via subscription   (Followers: 9, SJR: 0.823, h-index: 27)
Advances in the Study of Behavior     Full-text available via subscription   (Followers: 29, SJR: 1.321, h-index: 56)
Advances in Veterinary Medicine     Full-text available via subscription   (Followers: 17)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 13)
Advances in Virus Research     Full-text available via subscription   (Followers: 5, SJR: 1.878, h-index: 68)
Advances in Water Resources     Hybrid Journal   (Followers: 46, SJR: 2.408, h-index: 94)
Aeolian Research     Hybrid Journal   (Followers: 6, SJR: 0.973, h-index: 22)
Aerospace Science and Technology     Hybrid Journal   (Followers: 333, SJR: 0.816, h-index: 49)
AEU - Intl. J. of Electronics and Communications     Hybrid Journal   (Followers: 8, SJR: 0.318, h-index: 36)
African J. of Emergency Medicine     Open Access   (Followers: 6, SJR: 0.344, h-index: 6)
Ageing Research Reviews     Hybrid Journal   (Followers: 9, SJR: 3.289, h-index: 78)
Aggression and Violent Behavior     Hybrid Journal   (Followers: 430, SJR: 1.385, h-index: 72)
Agri Gene     Hybrid Journal  
Agricultural and Forest Meteorology     Hybrid Journal   (Followers: 15, SJR: 2.18, h-index: 116)
Agricultural Systems     Hybrid Journal   (Followers: 31, SJR: 1.275, h-index: 74)
Agricultural Water Management     Hybrid Journal   (Followers: 43, SJR: 1.546, h-index: 79)
Agriculture and Agricultural Science Procedia     Open Access   (Followers: 1)
Agriculture and Natural Resources     Open Access   (Followers: 2)
Agriculture, Ecosystems & Environment     Hybrid Journal   (Followers: 56, SJR: 1.879, h-index: 120)
Ain Shams Engineering J.     Open Access   (Followers: 5, SJR: 0.434, h-index: 14)
Air Medical J.     Hybrid Journal   (Followers: 5, SJR: 0.234, h-index: 18)
AKCE Intl. J. of Graphs and Combinatorics     Open Access   (SJR: 0.285, h-index: 3)
Alcohol     Hybrid Journal   (Followers: 11, SJR: 0.922, h-index: 66)
Alcoholism and Drug Addiction     Open Access   (Followers: 9)
Alergologia Polska : Polish J. of Allergology     Full-text available via subscription   (Followers: 1)
Alexandria Engineering J.     Open Access   (Followers: 1, SJR: 0.436, h-index: 12)
Alexandria J. of Medicine     Open Access   (Followers: 1)
Algal Research     Partially Free   (Followers: 9, SJR: 2.05, h-index: 20)
Alkaloids: Chemical and Biological Perspectives     Full-text available via subscription   (Followers: 2)
Allergologia et Immunopathologia     Full-text available via subscription   (Followers: 1, SJR: 0.46, h-index: 29)
Allergology Intl.     Open Access   (Followers: 5, SJR: 0.776, h-index: 35)
Alpha Omegan     Full-text available via subscription   (SJR: 0.121, h-index: 9)
ALTER - European J. of Disability Research / Revue Européenne de Recherche sur le Handicap     Full-text available via subscription   (Followers: 9, SJR: 0.158, h-index: 9)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 48, SJR: 4.289, h-index: 64)
Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring     Open Access   (Followers: 4)
Alzheimer's & Dementia: Translational Research & Clinical Interventions     Open Access   (Followers: 4)
Ambulatory Pediatrics     Hybrid Journal   (Followers: 6)
American Heart J.     Hybrid Journal   (Followers: 50, SJR: 3.157, h-index: 153)
American J. of Cardiology     Hybrid Journal   (Followers: 50, SJR: 2.063, h-index: 186)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 42, SJR: 0.574, h-index: 65)
American J. of Geriatric Pharmacotherapy     Full-text available via subscription   (Followers: 10, SJR: 1.091, h-index: 45)
American J. of Geriatric Psychiatry     Hybrid Journal   (Followers: 14, SJR: 1.653, h-index: 93)
American J. of Human Genetics     Hybrid Journal   (Followers: 31, SJR: 8.769, h-index: 256)
American J. of Infection Control     Hybrid Journal   (Followers: 26, SJR: 1.259, h-index: 81)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 32, SJR: 2.313, h-index: 172)
American J. of Medicine     Hybrid Journal   (Followers: 42, SJR: 2.023, h-index: 189)
American J. of Medicine Supplements     Full-text available via subscription   (Followers: 3)
American J. of Obstetrics and Gynecology     Hybrid Journal   (Followers: 189, SJR: 2.255, h-index: 171)
American J. of Ophthalmology     Hybrid Journal   (Followers: 62, SJR: 2.803, h-index: 148)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 6)
American J. of Orthodontics and Dentofacial Orthopedics     Full-text available via subscription   (Followers: 6, SJR: 1.249, h-index: 88)
American J. of Otolaryngology     Hybrid Journal   (Followers: 25, SJR: 0.59, h-index: 45)
American J. of Pathology     Hybrid Journal   (Followers: 27, SJR: 2.653, h-index: 228)
American J. of Preventive Medicine     Hybrid Journal   (Followers: 27, SJR: 2.764, h-index: 154)
American J. of Surgery     Hybrid Journal   (Followers: 37, SJR: 1.286, h-index: 125)
American J. of the Medical Sciences     Hybrid Journal   (Followers: 12, SJR: 0.653, h-index: 70)
Ampersand : An Intl. J. of General and Applied Linguistics     Open Access   (Followers: 6)
Anaerobe     Hybrid Journal   (Followers: 4, SJR: 1.066, h-index: 51)
Anaesthesia & Intensive Care Medicine     Full-text available via subscription   (Followers: 61, SJR: 0.124, h-index: 9)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 14)
Anales de Cirugia Vascular     Full-text available via subscription  
Anales de Pediatría     Full-text available via subscription   (Followers: 2, SJR: 0.209, h-index: 27)
Anales de Pediatría (English Edition)     Full-text available via subscription  
Anales de Pediatría Continuada     Full-text available via subscription   (SJR: 0.104, h-index: 3)
Analytic Methods in Accident Research     Hybrid Journal   (Followers: 4, SJR: 2.577, h-index: 7)
Analytica Chimica Acta     Hybrid Journal   (Followers: 39, SJR: 1.548, h-index: 152)
Analytical Biochemistry     Hybrid Journal   (Followers: 165, SJR: 0.725, h-index: 154)
Analytical Chemistry Research     Open Access   (Followers: 10, SJR: 0.18, h-index: 2)
Analytical Spectroscopy Library     Full-text available via subscription   (Followers: 11)
Anesthésie & Réanimation     Full-text available via subscription   (Followers: 1)
Anesthesiology Clinics     Full-text available via subscription   (Followers: 22, SJR: 0.421, h-index: 40)
Angiología     Full-text available via subscription   (SJR: 0.124, h-index: 9)
Angiologia e Cirurgia Vascular     Open Access   (Followers: 1)

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Journal Cover American Heart Journal
  [SJR: 3.157]   [H-I: 153]   [50 followers]  Follow
   Hybrid Journal Hybrid journal (It can contain Open Access articles)
   ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
   Published by Elsevier Homepage  [3175 journals]
  • Utility of an additive frailty tests index score for mortality risk
           assessment following transcatheter aortic valve replacement
    • Authors: Arie Steinvil; Kyle D. Buchanan; Sarkis Kiramijyan; Elizabeth Bond; Toby Rogers; Edward Koifman; Christian Shults; Linzhi Xu; Rebecca Torguson; Petros G. Okubagzi; Augusto D. Pichard; Lowell F. Satler; Itsik Ben-Dor; Ron Waksman
      Pages: 11 - 16
      Abstract: Publication date: June 2018
      Source:American Heart Journal, Volume 200
      Author(s): Arie Steinvil, Kyle D. Buchanan, Sarkis Kiramijyan, Elizabeth Bond, Toby Rogers, Edward Koifman, Christian Shults, Linzhi Xu, Rebecca Torguson, Petros G. Okubagzi, Augusto D. Pichard, Lowell F. Satler, Itsik Ben-Dor, Ron Waksman
      Background The impact of frailty assessment on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. Our aim was to evaluate the individual effect of each frailty test and the utility of an additive frailty index score on short- and long-term survival following TAVR. Methods Retrospective analysis of consecutive TAVR patients for whom a complete set of frailty tests was obtained: algorithm defined grip strength and 5-m walking tests, body mass index <20 kg/m2, Katz activities of daily living ≤4/6, serum albumin <3.5 g/dL. Frailty status was defined as having 3 or more positive frailty tests. Included were 498 patients with a mean age of 82±8 years. Results Frailty status, observed in 266 (53%) patients, was associated with both 30-day and 1-year mortality (6% vs. 2%, P =.016; 20% vs. 9%, P <.001; within the respective frailty groups). As compared to 0–2 frailty criteria, a higher frailty index score was associated with increased risk of death at 1 year (OR 2.23; 95% CI 1.14–4.34; P =.019 and OR 3.30; 95% CI 1.36–8.00; P =.008 for 3 and 4–5 frailty criteria met, respectively). In Cox regression analysis, frailty status was correlated with 1-year mortality (HR=2.2; 95%CI 1.25–3.96; P =.007), and a higher frailty index was associated with increased mortality risk (HR=2.0; 95% CI 1.08–3.7; P =.027; and HR=3.07; 95% CI 1.4–6.7; P =.005; for any 3, and 4–5 frailty criteria, respectively). Conclusions Frailty status and a higher frailty index score were associated with increased 1-year mortality risk following TAVR.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.01.007
      Issue No: Vol. 200 (2018)
  • B-type natriuretic peptide molecular forms for risk stratification and
           prediction of outcome after acute myocardial infarction
    • Authors: M. Zubair Israr; Liam M. Heaney; Leong L. Ng; Toru Suzuki
      Pages: 37 - 43
      Abstract: Publication date: June 2018
      Source:American Heart Journal, Volume 200
      Author(s): M. Zubair Israr, Liam M. Heaney, Leong L. Ng, Toru Suzuki
      Background B-type natriuretic peptide (BNP) is known to be a risk marker following acute myocardial infarction (MI). More recently, truncated molecular forms of the BNP molecule have been identified, with the association of these forms and outcome in acute MI not known. The present study investigated their use as risk stratifying biomarkers of this condition. Methods BNP molecular forms (BNP 5–32, BNP 4–32 and BNP 3–32) were measured in plasma from 1078 acute MI patients using immunocapture followed by MALDI-ToF-mass spectrometry. Associations of molecular forms with short-term and long-term adverse outcomes were assessed. Results BNP molecular forms were independent predictors of mortality/reinfarction, mortality/rehospitalization due to heart failure, and a composite of all events at 6 months, 1 year and 2 years and showed prognostic ability comparable with conventional BNP measurements (P <.001–0.026 vs. N-terminal [NT]-proBNP P <.001–0.020, respectively). Reclassification analyses showed BNP molecular forms successfully reclassified patient risk when used in addition to the GRACE clinical risk score (P ≤.005). BNP 5–32 showed utility as a secondary risk stratification biomarker when used in combination with the GRACE score and NT-proBNP by successful down-classification of high-risk patients. Conclusions BNP molecular forms were associated with poor prognosis at 6 months, 1 year and at 2 years in patients with acute MI. BNP 5–32 showed successful utility as a secondary marker in combination with NT-proBNP after GRACE scoring. This study suggests a potential role for BNP molecular forms in prognosis and risk stratification after acute MI.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.02.016
      Issue No: Vol. 200 (2018)
  • Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided
           Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate
           Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial
    • Authors: Jeehoon Kang; Bon-Kwon Koo; Xinyang Hu; Joo Myung Lee; Joo-Yong Hahn; Hyoung-Mo Yang; Eun-Seok Shin; Chang-Wook Nam; Joon-Hyung Doh; Bong-Ki Lee; Chul Ahn; JianAn Wang; Seung-Jae Tahk
      Pages: 7 - 12
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Jeehoon Kang, Bon-Kwon Koo, Xinyang Hu, Joo Myung Lee, Joo-Yong Hahn, Hyoung-Mo Yang, Eun-Seok Shin, Chang-Wook Nam, Joon-Hyung Doh, Bong-Ki Lee, Chul Ahn, JianAn Wang, Seung-Jae Tahk
      Background Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis. Trial design Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) trial is an international, multicenter, prospective, randomized clinical trial. A total of 1,700 consecutive patients with intermediate stenosis (40%-70% by visual estimation) in a major epicardial coronary artery will be randomized 1:1 to receive either FFR-guided or IVUS-guided PCI strategy. Patients will be treated with PCI according to the predefined criteria for revascularization; FFR ≤ 0.80 in the FFR-guided group and Minimal Lumen Area (MLA) ≤3 mm2 (or 3 mm2 <MLA ≤4 mm2 and plaque burden >70%) in the IVUS-guided group. The primary end point is the patient-oriented composite outcome, which is a composite of all-cause death, myocardial infarction, and any repeat revascularization at 24months after randomization. We will test noninferiority of current standard FFR-guided PCI strategy compared with IVUS-guided decision for PCI and stent optimization strategy. Conclusion The FLAVOUR trial will compare the safety and efficacy of FFR- and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. This study will provide an insight on optimal evaluation and treatment strategy for patients with intermediate coronary stenosis.

      PubDate: 2018-02-14T12:18:47Z
      DOI: 10.1016/j.ahj.2017.11.001
      Issue No: Vol. 199 (2018)
  • Rationale and design of a trial to personalize risk assessment in familial
           coronary artery disease
    • Authors: Thomas H Marwick; Kristyn Whitmore; Stephen J Nicholls; Tony Stanton; Geoffrey Mitchell; Andrew Tonkin; Christopher Blizzard; Amanda Neil; Catherine Jones; Gerald F Watts
      Pages: 22 - 30
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Thomas H Marwick, Kristyn Whitmore, Stephen J Nicholls, Tony Stanton, Geoffrey Mitchell, Andrew Tonkin, Christopher Blizzard, Amanda Neil, Catherine Jones, Gerald F Watts
      Background The lifetime risk of coronary artery disease (CAD) is doubled in people with a family history of premature disease, yet this risk is not captured in most 5- or 10-year risk assessment algorithms. Coronary artery calcium scoring (CCS) is a marker of subclinical CAD risk, which has been shown in observational studies to provide prognostic information that is incremental to clinical assessment; is relatively inexpensive; and is performed with a small radiation dose. However, the use of CCS in guiding prevention is not strongly supported by guidelines. Showing definitive evidence of the efficacy and cost-effectiveness of CCS is therefore of importance. Study design The proposed randomized controlled trial of the use of CCS will be targeted to 40- to 70-year-old first-degree relatives of patients with CAD onset <60 years old or second-degree relatives of patients with onset <50 years old. Control patients will undergo standard risk scoring and be blinded to CCS results. In the intervention group, primary prevention in patients undergoing CCS will be informed by this score. At 3 years, effectiveness will be assessed on change in plaque volume at computed tomography coronary angiography, the extent of which has been strongly linked to outcome. Summary The CAUGHT-CAD trial will provide evidence to inform the guidelines regarding the place of CCS in decision making regarding primary prevention of patients with a family history of premature disease.

      PubDate: 2018-02-25T12:40:29Z
      DOI: 10.1016/j.ahj.2017.09.011
      Issue No: Vol. 199 (2018)
  • Investigation of Motivational Interviewing and Prevention Consults to
           Achieve Cardiovascular Targets (IMPACT) trial
    • Authors: Eugenia Gianos; Antoinette Schoenthaler; Yu Guo; Judy Zhong; Howard Weintraub; Arthur Schwartzbard; James Underberg; Michael Schloss; Jonathan D. Newman; Sean Heffron; Edward A. Fisher; Jeffrey S. Berger
      Pages: 37 - 43
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Eugenia Gianos, Antoinette Schoenthaler, Yu Guo, Judy Zhong, Howard Weintraub, Arthur Schwartzbard, James Underberg, Michael Schloss, Jonathan D. Newman, Sean Heffron, Edward A. Fisher, Jeffrey S. Berger
      Background Patients undergoing cardiovascular (CV) procedures often have suboptimal CV risk factor control and may benefit from strategies targeting healthy lifestyle behaviors and education. Implementation of prevention strategies may be particularly effective at this point of heightened motivation. Methods A prospective, randomized, pilot study was conducted in 400 patients undergoing a nonurgent CV procedure (cardiac catheterization ± revascularization) to evaluate the impact of different prevention strategies. Patients were randomized in a 1:1:1 fashion to usual care (UC; group A, n = 134), in-hospital CV prevention consult (PC; group B, n = 130), or PC plus behavioral intervention program (telephone-based motivational interviewing and optional tailored text messages) (group C, n = 133). The primary end point was the Δ change in non–high-density lipoprotein cholesterol (non–HDL-C) from baseline to 6 month. Results The mean age was 64.6 ± 10.8 years, 23.7% were female, and 31.5% were nonwhite. After 6 months, the absolute difference in non–HDL-C for all participants was −19.8 mg/dL (95% CI −24.1 to −15.6, P < .001). There were no between-group differences in the primary end point for the combined PC groups (B and C) versus UC, with a Δ adjusted between group difference of −5.5 mg/dL (95% CI −13.1 to 2.1, P = .16). Patients in the PC groups were more likely to be on high-intensity statins at 6 months (52.9% vs 38.1%, P = .01). After excluding participants with baseline non–HDL-C <100 mg/dL (initial exclusion criterion), Δ non–HDL-C and Δ low-density lipoprotein cholesterol were improved in the PC groups compared to UC (non–HDL-C −8.13 mg/dL [−16.00 to −0.27], P = .04; low-density lipoprotein cholesterol −7.87mg/dL [−15.10 to −0.64], P = .03). Conclusions Although non–HDL-C reduction at 6 months following a nonurgent CV procedure was not significant in the overall cohort, an increased uptake in high-potency statins may translate into improved long-term health outcomes and cost reductions.

      PubDate: 2018-02-25T12:40:29Z
      DOI: 10.1016/j.ahj.2017.12.019
      Issue No: Vol. 199 (2018)
  • Transcatheter closure of patent foramen ovale following cryptogenic
           stroke: An updated meta-analysis of randomized controlled trials
    • Authors: Haris Riaz; Muhammad Shahzeb Khan; Aldo L. Schenone; Anam A. Waheed; Arooj Razzak Khan; Richard A. Krasuski
      Pages: 44 - 50
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Haris Riaz, Muhammad Shahzeb Khan, Aldo L. Schenone, Anam A. Waheed, Arooj Razzak Khan, Richard A. Krasuski
      Background Transcatheter closure of patent foramen ovale (PFO) after cryptogenic stroke has long been a contentious issue. Herein, we pool aggregate data examining safety and efficacy of transcatheter closure of PFO compared with medical therapy following initial cryptogenic stroke. Methods We searched for randomized clinical trials (RCT) that compared device closure with medical management and reported on subsequent stroke and adverse events. Stroke was considered as the primary efficacy endpoint, whereas bleeding and atrial fibrillation were considered primary safety endpoints. Data were pooled by the random effects model and I2 was used to assess heterogeneity. Results A total of 5 RCT investigating 3630 patients met inclusion criteria. Pooled analysis revealed that device closure compared to medical management was associated with a significant reduction in stroke (RR=0.3, 95% CI=0.02–0.57). There was, however, a significant increase in atrial arrhythmias with device therapy (RR=4.8, 95% CI=2.2–10.7). We found no increase in bleeding (RR=0.80, 95% CI=0.5–1.4), death (RR=0.76, 95% CI=0.3–1.99) or “any adverse events” (RR=1.02, 95% CI=0.85–1.23) with device therapy. Sub-group analysis revealed that device closure significantly reduced the incidence of the composite primary endpoint among patients who had moderate to large shunt sizes (RR=0.22, 95% CI=0.02–0.42). Conclusions Transcatheter closure is associated with a significant reduction in the risk of stroke compared to medical management at the expense of an increased risk of atrial arrhythmias.

      PubDate: 2018-02-25T12:40:29Z
      DOI: 10.1016/j.ahj.2018.01.008
      Issue No: Vol. 199 (2018)
  • A genotype-directed comparative effectiveness trial of Bucindolol and
           metoprolol succinate for prevention of symptomatic atrial
           fibrillation/atrial flutter in patients with heart failure: Rationale and
           design of the GENETIC-AF trial
    • Authors: Jonathan P. Piccini; Stuart J. Connolly; William T. Abraham; Jeff S. Healey; Benjamin A. Steinberg; Hussein R. Al-Khalidi; Patricia Dignacco; Dirk J. van Veldhuisen; William H. Sauer; Michel White; Stephen B. Wilton; Inder S. Anand; Christopher Dufton; Debra A. Marshall; Ryan G. Aleong; Gordon W. Davis; Richard L. Clark; Laura L. Emery; Michael R. Bristow
      Pages: 51 - 58
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Jonathan P. Piccini, Stuart J. Connolly, William T. Abraham, Jeff S. Healey, Benjamin A. Steinberg, Hussein R. Al-Khalidi, Patricia Dignacco, Dirk J. van Veldhuisen, William H. Sauer, Michel White, Stephen B. Wilton, Inder S. Anand, Christopher Dufton, Debra A. Marshall, Ryan G. Aleong, Gordon W. Davis, Richard L. Clark, Laura L. Emery, Michael R. Bristow
      Background Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrhythmic effects and increased efficacy for preventing heart failure events in patients homozygous for the major allele of the ADRB1 Arg389Gly polymorphism (ADRB1 Arg389Arg genotype). The safety and efficacy of bucindolol for the prevention of AF or atrial flutter (AFL) in these patients has not been proven in randomized trials. Methods/design The Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Metoprolol Succinate for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure (GENETIC-AF) trial is a multicenter, randomized, double-blinded “seamless” phase 2B/3 trial of bucindolol hydrochloride versus metoprolol succinate, for the prevention of symptomatic AF/AFL in patients with reduced ejection fraction heart failure (HFrEF). Patients with pre-existing HFrEF and recent history of symptomatic AF are eligible for enrollment and genotype screening, and if they are ADRB1 Arg389Arg, eligible for randomization. A total of approximately 200 patients will comprise the phase 2B component and if pre-trial assumptions are met, 620 patients will be randomized at approximately 135 sites to form the Phase 3 population. The primary endpoint is the time to recurrence of symptomatic AF/AFL or mortality over a 24-week follow-up period, and the trial will continue until 330 primary endpoints have occurred. Conclusions GENETIC-AF is the first randomized trial of pharmacogenetic guided rhythm control, and will test the safety and efficacy of bucindolol compared with metoprolol succinate for the prevention of recurrent symptomatic AF/AFL in patients with HFrEF and an ADRB1 Arg389Arg genotype. ( NCT01970501).

      PubDate: 2018-02-25T12:40:29Z
      DOI: 10.1016/j.ahj.2017.12.001
      Issue No: Vol. 199 (2018)
  • Resource utilization and outcome among patients with selective versus
           nonselective troponin testing
    • Authors: Alex R. Campbell; Alexander J. Rodriguez; David M. Larson; Craig E. Strauss; Ross F. Garberich; Matthew F. Partridge; Timothy D. Henry; Scott W. Sharkey
      Pages: 68 - 74
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Alex R. Campbell, Alexander J. Rodriguez, David M. Larson, Craig E. Strauss, Ross F. Garberich, Matthew F. Partridge, Timothy D. Henry, Scott W. Sharkey
      Objective In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. Troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for resource utilization and outcome. Therefore, we examined selective versus nonselective troponin testing with respect to patient characteristics, resource utilization, and outcome. Methods This retrospective 1-year study included all patients with troponin testing at a U.S. emergency department. Testing was classified as selective (ACS) or nonselective (non-ACS) based on admission ICD-9 codes. Troponin upper reference limit (URL) was ≥99th percentile. Results Among 47,053 patients, troponin was measured in 9109 (19%) of whom 5764 were hospitalized. Admission diagnosis was non-ACS in 4427 (77%) and ACS in 1337 (23%). Non-ACS patients were older, 71±17 versus 65±16 years, with longer hospital stay, 77 versus 32 h, and greater 1-year mortality 22% versus 6.7%; P <.001. In patients with troponin ≥URL, revascularization was performed in 64 (4.7%) of non-ACS versus 213 (48%) of ACS; P <.001. In patients with troponin <URL, 1-year mortality was 16% in non-ACS versus 3.5% in ACS; P <.001. In those with troponin ≥URL, 1-year mortality was 35% in non-ACS versus 13% in ACS; P <.001. Death was non-cardiac in >80% of the non-ACS population Conclusions Contemporary troponin testing is frequently nonselective. The non-ACS and ACS populations differ significantly regarding clinical characteristics, revascularization rates, and outcomes. Troponin elevation is a powerful predictor of 1-year mortality in non-ACS, this association reveals an opportunity for risk stratification and targeted therapy. Key Questions In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. However, troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for hospital resource utilization and patient outcome. Our findings demonstrate contemporary troponin testing is largely nonselective (77% of testing was performed in patients without acute coronary syndrome). In comparison to patients with acute coronary syndrome, those with non-acute coronary syndrome are older, with longer hospital stay, lower revascularization rates, and greater 1-year mortality. Troponin elevation identifies a high-risk population in both acute coronary syndrome and non-acute coronary syndrome populations, yet effective treatment for the latter is lacking.

      PubDate: 2018-02-25T12:40:29Z
      DOI: 10.1016/j.ahj.2018.01.010
      Issue No: Vol. 199 (2018)
  • Knowledge to action: Rationale and design of the Patient-Centered Care
           Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized
    • Authors: Harriette G.C. Van Spall; Shun Fu Lee; Feng Xie; Dennis T. Ko; Lehana Thabane; Quazi Ibrahim; Peter R. Mitoff; Michael Heffernan; Manish Maingi; Michael C. Tjandrawidjaja; Mohammad I. Zia; Mohamed Panju; Richard Perez; Kim D. Simek; Liane Porepa; Ian D. Graham; R. Brian Haynes; Dilys Haughton; Stuart J. Connolly
      Pages: 75 - 82
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Harriette G.C. Van Spall, Shun Fu Lee, Feng Xie, Dennis T. Ko, Lehana Thabane, Quazi Ibrahim, Peter R. Mitoff, Michael Heffernan, Manish Maingi, Michael C. Tjandrawidjaja, Mohammad I. Zia, Mohamed Panju, Richard Perez, Kim D. Simek, Liane Porepa, Ian D. Graham, R. Brian Haynes, Dilys Haughton, Stuart J. Connolly
      Introduction Heart Failure (HF) is a common cause of hospitalization in older adults. The transition from hospital to home is high-risk, and gaps in transitional care can increase the risk of re-hospitalization and death. Combining health care services supported by meta-analyses, we designed the PACT-HF transitional care model. Methods Adopting an integrated Knowledge Translation (iKT) approach in which decision-makers and clinicians are partners in research, we implement and test the effectiveness of PACT-HF among patients hospitalized for HF. We use a pragmatic stepped wedge cluster randomized trial design to introduce the complex health service intervention to 10 large hospitals in a randomized sequence until all hospitals initiate the intervention. The goal is for all patients hospitalized with HF to receive self-care education, multidisciplinary care, and early follow-up with their health care providers; and in addition, for high-risk patients to receive post-discharge nurse-led home visits and outpatient care in Heart Function clinics. This requires integration of care across hospitals, home care agencies, and outpatient clinics in our publicly funded health care system. While hospitals are the unit of recruitment and analysis, patients (estimated sample size of 3200) are the unit of analysis. Primary outcomes are hierarchically ordered as time to composite all-cause readmissions / emergency department (ED) visits / death at 3 months and time to composite all-cause readmissions / ED visits at 30 days. In a nested study of 8 hospitals, we measure the patient-centered outcomes of Discharge Preparedness, Care Transitions Quality, and Quality Adjusted Life Years (QALY); and the 6-month health care resource use and costs. We obtain all clinical and cost outcomes via linkages to provincial administrative databases. Conclusions This protocol describes the implementation and testing of a transitional care model comprising health care services informed by high-level evidence. The study adopts an iKT and pragmatic approach, uses a robust study design, links clinical trial data with outcomes held in administrative databases, and includes patient-reported outcomes. Findings will have implications on clinical practice, health care policy, and Knowledge Translation (KT) research methodology.

      PubDate: 2018-02-25T12:40:29Z
      DOI: 10.1016/j.ahj.2017.12.013
      Issue No: Vol. 199 (2018)
  • Prevalent digoxin use and subsequent risk of death or hospitalization in
           ambulatory heart failure patients with a reduced ejection
           fraction—Findings from the Heart Failure: A Controlled Trial
           Investigating Outcomes of Exercise Training (HF-ACTION) randomized
           controlled trial
    • Authors: Andrew P. Ambrosy; Ankeet S. Bhatt; Amanda L. Stebbins; Lisa M. Wruck; Marat Fudim; Stephen J. Greene; William E. Kraus; Christopher M. O'Connor; Ileana L. Piña; David J. Whellan; Robert J. Mentz
      Pages: 97 - 104
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Andrew P. Ambrosy, Ankeet S. Bhatt, Amanda L. Stebbins, Lisa M. Wruck, Marat Fudim, Stephen J. Greene, William E. Kraus, Christopher M. O'Connor, Ileana L. Piña, David J. Whellan, Robert J. Mentz
      Background Despite more than 200 years of clinical experience and a pivotal trial, recently published research has called into question the safety and efficacy of digoxin therapy in heart failure (HF). Methods HF-ACTION ( Number: NCT00047437) enrolled 2331 outpatients with HF and an EF ≤35% between April 2003 and February 2007 and randomized them to aerobic exercise training versus usual care. Patients were grouped according to prevalent digoxin status at baseline. The association between digoxin therapy and outcomes was assessed using Cox proportional hazard and inverse-probability weighted (IPW) regression models adjusted for demographics, medical history, medications, laboratory values, quality of life, and exercise parameters. Results The prevalence of digoxin therapy decreased from 52% during the first 6 months of enrollment to 35% at the end of the HF-ACTION trial (P <0.0001). Study participants were 59± 13 years of age, 72% were male, and approximately half had an ischemic etiology of HF. Patients receiving digoxin at baseline tended to be younger and were more likely to report New York Heart Association functional class III/IV symptoms (rather than class II) compared to those not receiving digoxin. Patients taking digoxin had worse baseline exercise capacity as measured by peak VO2 and 6-min walk test and greater impairments in health status as reflected by the Kansas City Cardiomyopathy Questionnaire. The association between digoxin and the risk of death or hospitalization differed depending on whether Cox proportional hazard (Hazard Ratio 1.03, 95% Confidence Interval 0.92–1.16; P = .62) or IPW regression models (HR 1.08, 95% CI 1.00–1.17; P = .057) were used to adjust for potential confounders. Conclusion Although digoxin use was associated with high-risk clinical features, the association between digoxin therapy and outcomes was dependent on the statistical methods used for multivariable adjustment. Clinical equipoise exists and additional prospective research is required to clarify the role of digoxin in contemporary clinical practice including its effects on functional capacity, quality of life, and long-term outcomes.

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2018.02.004
      Issue No: Vol. 199 (2018)
  • Effects of a 12-week mHealth program on peak VO2 and physical activity
           patterns after completing cardiac rehabilitation: A randomized controlled
    • Authors: Brian D. Duscha; Lucy W. Piner; Mahesh P. Patel; Karen P. Craig; Morgan Brady; Robert W. McGarrah; Connie Chen; William E. Kraus
      Pages: 105 - 114
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Brian D. Duscha, Lucy W. Piner, Mahesh P. Patel, Karen P. Craig, Morgan Brady, Robert W. McGarrah, Connie Chen, William E. Kraus
      Background Site-based cardiac rehabilitation (CR) provides supervised exercise, education and motivation for patients. Graduates of CR have improved exercise tolerance. However, when participation in CR ceases, adherence to regular physical activity often declines, consequently leading to worsening risk factors and clinical events. Therefore, the purpose of this pilot study was to evaluate if a mHealth program could sustain the fitness and physical activity levels gained during CR. Methods and Results A 12-week mHealth program was implemented using physical activity trackers and health coaching. Twenty-five patients were randomized into mHealth or usual care after completing CR. The combination of a 4.7±13.8% increase in the mHealth and a 8.5±11.5% decrease in the usual care group resulted in a difference between groups (P ≤.05) for absolute peak VO2. Usual care decreased the amount of moderate-low physical activity minutes per week (117±78 vs 50±53; P <.05) as well as moderate-high (111±87 vs 65±64; P <.05). mHealth increased moderate-high physical activity (138±113 vs 159±156; NS). The divergent changes between mHealth and usual care in moderate-high physical activity minutes/week resulted in a difference between groups (21±103 vs – 46±36; P <.05). Conclusions A 12-week mHealth program of physical activity trackers and health coaching following CR graduation can sustain the gains in peak VO2 and physical activity achieved by site-based CR.

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2018.02.001
      Issue No: Vol. 199 (2018)
  • Telemedicine cardiovascular risk reduction in veterans: The CITIES trial
    • Authors: Hayden B. Bosworth; Maren K. Olsen; Felicia McCant; Karen M. Stechuchak; Susanne Danus; Matthew J. Crowley; Karen M. Goldstein; Leah L. Zullig; Eugene Z. Oddone
      Pages: 122 - 129
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Hayden B. Bosworth, Maren K. Olsen, Felicia McCant, Karen M. Stechuchak, Susanne Danus, Matthew J. Crowley, Karen M. Goldstein, Leah L. Zullig, Eugene Z. Oddone
      Background Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction. Methods This is a 2-arm (clinical pharmacist specialist–delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes. Results Among 428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy. Relative to the education control group, the clinical pharmacist specialist–delivered intervention did not show a reduction in CVD risk score at 6 months (−1.8, 95% CI −3.9 to 0.3; P = .10) or 12 months (−0.3, 95% CI −2.4 to 1.7; P = .74). No differences were seen in systolic blood pressure, diastolic blood pressure, or low-density lipoprotein at 6 or 12 months. We did observe a significant decline in total cholesterol at 6 months (−7.0, 95% CI −13.4 to −0.6; P = .03) in the intervention relative to education control group. Among patients in the intervention group, 34% received at least 5 of the 12 planned intervention calls and were considered “compliers.” A sensitivity analysis of the “complier average causal effect” of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 (95% CI −12.0 to 0.7) at 6 months and −1.7 (95% CI −7.6 to 4.8) at 12 months. Conclusions Despite increased access to pharmacist resources, we did not observe significant improvements in CVD risk for patients randomized to the intervention compared to education control over 12 months. However, the intervention may have positive impact among those who actively participate, particularly in the short term.

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2018.02.002
      Issue No: Vol. 199 (2018)
  • Rationale and methods of the Prospective Study of Biomarkers, Symptom
           Improvement, and Ventricular Remodeling During Sacubitril/Valsartan
           Therapy for Heart Failure (PROVE-HF)
    • Authors: James L. Januzzi; Javed Butler; Emmanuel Fombu; Alan Maisel; Kevin McCague; Ileana L. Piña; Margaret F. Prescott; Jerome B. Riebman; Scott Solomon
      Pages: 130 - 136
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): James L. Januzzi, Javed Butler, Emmanuel Fombu, Alan Maisel, Kevin McCague, Ileana L. Piña, Margaret F. Prescott, Jerome B. Riebman, Scott Solomon
      Background Sacubitril/valsartan is an angiotensin receptor–neprilysin inhibitor indicated for the treatment of patients with chronic heart failure (HF) with reduced ejection fraction; however, its mechanism of benefit remains unclear. Biomarkers that are linked to ventricular remodeling, myocardial injury, and fibrosis may provide mechanistic insight and important clinical guidance regarding sacubitril/valsartan use. Methods This 52-week, multicenter, open-label, single-arm study is designed to (1) correlate biomarker changes with cardiac remodeling parameters, cardiovascular outcomes, and patient-reported outcome data and (2) determine short- and long-term changes in concentrations of biomarkers related to potential mechanisms of action and effects of sacubitril/valsartan therapy. Approximately 830 patients with HF with reduced ejection fraction will be initiated and titrated on sacubitril/valsartan according to United States prescribing information. Primary efficacy end points include the changes in N-terminal pro–B-type natriuretic peptide concentrations and cardiac remodeling from baseline to 1 year. Secondary end points include changes in concentrations of N-terminal pro–B-type natriuretic peptide and remodeling to 6 months, and changes in patient-reported outcomes using the Kansas City Cardiomyopathy Questionnaire-23 from baseline to 1 year. In addition, several other relevant biomarkers will be measured. Biomarker changes relative to the number of cardiovascular events in 12 months will also be assessed as exploratory end points. Conclusions Results from the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF) will help establish a mechanistic understanding of angiotensin receptor–neprilysin inhibitor therapeutic benefits and provide clinicians with clarity on how to interpret information on biomarkers during treatment (PROVE-HF identifier: NCT02887183).
      Graphical abstract image

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2017.12.021
      Issue No: Vol. 199 (2018)
  • Dual antiplatelet therapy for perioperative myocardial infarction
           following CABG surgery
    • Authors: Alice Wang; Angie Wu; Daniel Wojdyla; Renato D. Lopes; L. Kristin Newby; Mark F. Newman; Peter K. Smith; John H. Alexander
      Pages: 150 - 155
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Alice Wang, Angie Wu, Daniel Wojdyla, Renato D. Lopes, L. Kristin Newby, Mark F. Newman, Peter K. Smith, John H. Alexander
      Objectives Perioperative myocardial infarction (MI) after coronary artery bypass graft surgery (CABG) has been associated with adverse outcome. Whether perioperative MI should be treated with dual antiplatelet therapy (DAPT) is unknown. We compared the effect of DAPT versus aspirin alone on short-term outcomes among patients with perioperative MI following CABG. Methods We used data from 3 clinical trials that enrolled patients undergoing isolated CABG: PREVENT IV (2002–2003), MEND-CABG II (2004–2005), and RED-CABG (2009–2010) (n = 9117). Perioperative MI was defined as CK-MB >5 times the upper limit of normal within 24 h of surgery (n = 2052). DAPT was defined as DAPT given after surgery and prior to discharge. A Cox regression model was used to assess the association between DAPT and 30-day nonfatal MI, stroke, or mortality after adjustment for baseline covariates. Results DAPT (n = 527) and aspirin alone (n = 1525) cohorts were similar in baseline comorbidities. Off pump bypass was used in 5.2% (n = 106) of patients. There was no difference in the 30-day composite of death, MI or stroke between patients receiving DAPT versus aspirin alone, nor in any of the individual components. There were fewer all-cause re-hospitalizations at 30 days following surgery among patients in the DAPT group (adjusted HR 0.71, CI 0.52–0.97, P = .033). Conclusion One-quarter of CABG patients who had perioperative MI were treated with DAPT. DAPT was not associated with a difference in MI, stroke, or mortality at 30 days, but was associated with fewer re-hospitalizations. Further studies are needed to determine the optimal antiplatelet regimen following perioperative MI. What is already known about this subject' Perioperative myocardial infarction portends poor outcome but optimal management is currently unclear. While dual antiplatelet therapy is standard of care for acute coronary syndrome, its role in perioperative myocardial infarction is unknown. What does this study add' Dual antiplatelet therapy use during perioperative myocardial infarction was not associated with a difference in myocardial infarction, stroke or mortality at 30 days. It was, however, associated with fewer re-hospitalizations at 30 days. How might this impact on clinical practice' Dual antiplatelet therapy may be a potential treatment option for perioperative myocardial infarction after CABG surgery. Further studies are needed to better understand treatment for this disease process.

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2018.02.006
      Issue No: Vol. 199 (2018)
  • The prognostic value of heart rate recovery in patients with coronary
           artery disease: A systematic review and meta-analysis
    • Authors: Sangeeta Lachman; Michel S. Terbraak; Jacqueline Limpens; Harald Jorstad; Cees Lucas; Wilma Scholte op Reimer; S. Matthijs Boekholdt; Gerben ter Riet; Ron J.G. Peters
      Pages: 163 - 169
      Abstract: Publication date: May 2018
      Source:American Heart Journal, Volume 199
      Author(s): Sangeeta Lachman, Michel S. Terbraak, Jacqueline Limpens, Harald Jorstad, Cees Lucas, Wilma Scholte op Reimer, S. Matthijs Boekholdt, Gerben ter Riet, Ron J.G. Peters
      Background Routine outpatient care of patients with coronary artery disease (CAD) lacks a simple measure of physical fitness and risk of mortality. Heart rate recovery (HRR) is noninvasive and easily obtainable in outpatient settings. Prior studies have suggested that delayed postexercise HRR in the first minutes is associated with mortality in several types of populations. However, a comprehensive overview of the prognostic value of delayed HRR for time to mortality specifically in CAD patients is not available. The purpose of the current meta-analysis is to evaluate the prognostic value of delayed HRR in CAD patients. Methods We conducted a systematic search in OVID MEDLINE and OVID EMBASE to identify studies reporting on HRR and risk of incident cardiovascular events or mortality in CAD patients. Hazard ratios for delayed versus nondelayed HRR were pooled using random-effects meta-analysis. Results Four studies were included, comprising 2,428 CAD patients. The study quality of the included studies was rated moderate (n = 2) to high (n = 2). Delayed HRR was defined by ≤12 to ≤21 beat/min in the recovery period. During follow-up (range 2.0-9.8 years), 151 patients died (6.2% [range 2.5%-19.5%]). Only data on mortality could be pooled. Heterogeneity was limited (I 2 = 32%; P = .23); pooled unadjusted hazard ratio for mortality, based on 3 studies, was 5.8 (95% CI 3.2-10.4). Conclusions In CAD patients, delayed HRR is significantly associated with all-cause mortality. As exercise testing is performed routinely in CAD patients, HRR can be considered in monitoring exercise; still, further research must investigate the addition of HRR in current risk scores.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.02.008
      Issue No: Vol. 199 (2018)
  • Treatment of Sleep-Disordered Breathing in Heart Failure Impacts Cardiac
           Remodeling: Insights from the CAT-HF Trial
    • Authors: Melissa A. Daubert; David J. Whellan; Holger Woehrle; Gudaye Tasissa; Kevin J. Anstrom; JoAnn Lindenfeld; Adam Benjafield; Amy Blase; Naresh Punjabi; Mona Fiuzat; Olaf Oldenburg; Christopher M. O'Connor
      Abstract: Publication date: Available online 8 April 2018
      Source:American Heart Journal
      Author(s): Melissa A. Daubert, David J. Whellan, Holger Woehrle, Gudaye Tasissa, Kevin J. Anstrom, JoAnn Lindenfeld, Adam Benjafield, Amy Blase, Naresh Punjabi, Mona Fiuzat, Olaf Oldenburg, Christopher M. O'Connor
      Background Sleep-disordered breathing (SDB), including central and obstructive sleep apnea, is a marker of poor prognosis in heart failure (HF) and may worsen cardiac dysfunction over time. Treatment of SDB with adaptive servo-ventilation (ASV) may reverse pathologic cardiac remodeling in HF patients. Methods The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Servo-Ventilation Therapy in Heart Failure (CAT-HF) trial randomized patients with acute decompensated HF and confirmed SDB to either optimal medical therapy (OMT) or treatment with ASV and OMT. Patients with reduced ejection fraction (HFrEF) or preserved EF (HFpEF) were included. Echocardiograms, performed at baseline and 6months, assessed cardiac size and function and evaluated cardiac remodeling over time. The CAT-HF trial was stopped early in response to the SERVE-HF trial, which found increased mortality among HFrEF patients with central sleep apnea treated with ASV. Results Of the 126 patients enrolled prior to trial cessation, 95 had both baseline and 6-month echocardiograms (77 HFrEF and 18 HFpEF). Among HFrEF patients, both treatment arms demonstrated a significant increase in EF: +4.3% in the ASV group (0.0004) and+4.6% in OMT alone (P =.007) and a significant decrease in LV end-systolic volume index: −9.4ml/m2 in the ASV group (P =.01) and−8.6ml/m2 in OMT alone (P =.003). Reductions in left atrial (LA) volume and E/e’ were greater in the ASV arm, while patients receiving OMT alone demonstrated more improvement in right ventricular function. HFpEF patients treated with ASV also had a decrease in LA size that was greater than those receiving OMT alone. Although there were significant intragroup changes within the ASV+OMT and OMT alone groups, there were no significant intergroup differences at 6months. Conclusions Significant reverse LV remodeling was seen among HFrEF patients with SDB regardless of treatment allocation. Substantial reductions in LA volume among HFrEF and HFpEF patients receiving ASV suggests that ASV treatment may also improve diastolic function and warrants further investigation.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.026
  • Analysis of Outcomes for 15,259 U.S. Patients with Acute Myocardial
           Infarction Cardiogenic Shock (AMICS) Supported with the Impella Device
    • Authors: William W. O’Neill; Cindy Grines; Theodore Schreiber; Jeffrey Moses; Brijeshwar Maini; Simon Dixon; E. Magnus Ohman
      Abstract: Publication date: Available online 7 April 2018
      Source:American Heart Journal
      Author(s): William W. O’Neill, Cindy Grines, Theodore Schreiber, Jeffrey Moses, Brijeshwar Maini, Simon Dixon, E. Magnus Ohman

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.024
  • Optimizing primary care management of atrial fibrillation: the rationale
           and methods of the Integrated Management Program Advancing Community
           Treatment of Atrial Fibrillation (IMPACT-AF) study
    • Authors: Jafna L. Cox; R Parkash; SSR Abidi; L Thabane; F Xie; J MacKillop; SR Abidi; A Ciaccia; SH Choudhri; A Abusharekh; J Nemis-White
      Abstract: Publication date: Available online 7 April 2018
      Source:American Heart Journal
      Author(s): Jafna L. Cox, R Parkash, SSR Abidi, L Thabane, F Xie, J MacKillop, SR Abidi, A Ciaccia, SH Choudhri, A Abusharekh, J Nemis-White
      The Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) is an investigator designed, prospective, randomized, un-blinded, cluster design clinical trial, conducted in the primary care setting of Nova Scotia, Canada. Its aim is to evaluate whether an electronic Clinical Decision Support System (CDSS) designed to assist both practitioners and patients with evidence-based management strategies for Atrial Fibrillation (AF) can improve process of care and outcomes in a cost-efficient manner as compared to usual AF care. At least 200 primary care providers are being recruited and randomized at the level of the practice to control (usual care) or intervention (eligible to access to CDSS) cohorts. Over 1,000 patients of participating providers with confirmed AF will be managed per their provider’s respective assignment. The targeted primary clinical outcome is a reduction in the composite of unplanned cardiovascular (CV) or major bleeding hospitalizations and AF-related emergency department visits. Secondary clinical outcomes, process of care, patient and provider satisfaction as well as economic costs at the system and patient levels are being examined. The trial is anticipated to report in 2018.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.04.008
  • Clinical Trials Evaluating Red Blood Cell Transfusion Thresholds: An
           Updated Systematic Review and with Additional Focus on Patients with
           Cardiovascular Disease
    • Authors: Jeffrey L Carson; Simon J Stanworth; John H. Alexander; Nareg Roubinian; Dean A Fergusson; Darrell J Triulzi; Shaun G Goodman; Sunil V. Rao; Carolyn Doree; Paul C Hebert
      Abstract: Publication date: Available online 7 April 2018
      Source:American Heart Journal
      Author(s): Jeffrey L Carson, Simon J Stanworth, John H. Alexander, Nareg Roubinian, Dean A Fergusson, Darrell J Triulzi, Shaun G Goodman, Sunil V. Rao, Carolyn Doree, Paul C Hebert
      Background Several new trials evaluating transfusion strategies in patients with cardiovascular disease have recently been published increasing the number of enrolled patients by over 30%. Objectives To evaluate transfusion thresholds in patients with cardiovascular disease. Methods We conducted an updated systematic review of randomized trials that compared patients assigned to maintain a lower (restrictive transfusion strategy) or higher (liberal transfusion strategy) hemoglobin concentration. We focused on new trial data in patients with cardiovascular disease. The primary outcome was 30-day mortality. Specific subgroups were patients undergoing cardiac surgery and with acute myocardial infarction. Results A total of 37 trials that enrolled 19,049 patients were appraised. In cardiac surgery, mortality at 30days was comparable between groups (risk ratio 0.99; 95% confidence interval 0.74 to 1.33). In two small trials (n=154) in patients with myocardial infarction, the point estimate for the mortality risk ratio was 3.88 (95% confidence interval, 0.83 to 18.13) favoring the liberal strategy. Overall, from 26 trials enrolling 15,681 patients, 30-day mortality was not different between restrictive and liberal transfusion strategies (risk ratio 1.0, 95% confidence interval, 0.86 to 1.16). Overall, and in the cardiovascular disease subgroup, there were no significant differences observed across a range of secondary outcomes. Conclusions New trials in patients undergoing cardiac surgery establish that a restrictive transfusion strategy of 7 to 8g/dL is safe and decreased red cell use by 24%. Further research is needed to define the optimal transfusion threshold in patients with acute myocardial infarction.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.04.007
  • GlycA and hsCRP are Independent and Additive Predictors of Future
           Cardiovascular Events Among Patients Undergoing Angiography: The
           Intermountain Heart Collaborative Study
    • Authors: Joseph B. Muhlestein; Heidi T. May; Oxana Galenko; Kirk U. Knowlton; James D. Otvos; Margery A. Connelly; Donald L. Lappe; Jeffrey L. Anderson
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): Joseph B. Muhlestein, Heidi T. May, Oxana Galenko, Kirk U. Knowlton, James D. Otvos, Margery A. Connelly, Donald L. Lappe, Jeffrey L. Anderson
      Background GlycA is an inflammatory marker that is raised in patients with cardiometabolic diseases and associated with cardiovascular (CV) events. We sought to determine if GlycA adds independent value to hsCRP for CV risk prediction. Methods Patients in the Intermountain Heart Collaborative Study who underwent coronary angiography and had plasma GlycA and hsCRP levels were studied (n=2996). Patients were followed for 7.0±2.8years. GlycA and hsCRP were moderately correlated (r=0.46, P <.0001). GlycA and hsCRP concentrations were stratified into high and low categories by their median values. Multivariable cox hazard regression was utilized to determine the associations of GlycA quartiles, as well as high and low categories of GlycA and hsCRP, with major adverse cardiovascular events (MACE) defined as the composite of death, myocardial infarction (MI), heart failure (HF) hospitalization, and stroke. Results The highest GlycA quartile was associated with future MACE [HR: 1.43; 95% CI: 1.22–1.69;P <.0001]. Patients with high GlycA and high hsCRP had more diabetes, hyperlipidemia, hypertension, HF, renal failure and MI, but not coronary artery disease. High GlycA and hsCRP (H/H) versus low GlycA and hsCRP (L/L) was associated with MACE, death and HF hospitalization, but not MI or stroke. Combined MACE rates were 33.5%, 41.3%, 35.7% and 49.1% for L/L, L/H, H/L and H/H categories of GlycA/hsCRP, respectively (p-trend <0.0001). The interaction between GlycA and hsCRP was significant for the outcome of death (P =.03). Conclusion In this study, levels of GlycA and hsCRP were independent and additive markers of risk for MACE, death and HF hospitalization.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.04.003
  • Association Between Ventricular Fibrillation Amplitude Immediately Prior
           to Defibrillation and Defibrillation Success in Out of Hospital Cardiac
    • Authors: Jessica R Balderston; Zachary M Gertz; Kenneth A Ellenbogen; Kelly P Schaaf; Joseph P Ornato
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): Jessica R Balderston, Zachary M Gertz, Kenneth A Ellenbogen, Kelly P Schaaf, Joseph P Ornato
      Background Several characteristics of the ventricular fibrillation (VF) waveform during cardiac arrest are associated with defibrillation success, including peak amplitude in the seconds prior to defibrillation. It is not known if immediate pre-defibrillation amplitude is associated with successful defibrillation, return of spontaneous circulation (ROSC) or survival to hospital discharge (SHD). Methods We analyzed automated external defibrillation recordings of 80 patients with out-of-hospital VF cardiac arrest who received 284 defibrillations. We recorded the maximum amplitude during 3-second ECG tracings prior to each defibrillation attempt and the amplitude immediately prior to defibrillation. Results Both the amplitude just prior to defibrillation and the highest amplitude within 3seconds of the defibrillation were significantly higher in successful vs unsuccessful defibrillations (0.21 vs 0.11mV, p=<0.0001 and 0.51 vs 0.36mV, p=<0.0001). Amplitude immediately prior to defibrillation and maximal amplitude within 3seconds of defibrillation were also higher in defibrillations with ROSC vs. defibrillations without ROSC (0.23 vs. 0.12mV, P <.0001; and 0.52 vs. 0.38mV, P<.0001). In defibrillations that resulted in SHD, immediate pre-defibrillation amplitude and maximum amplitude were also significantly larger (0.20 vs. 0.11mV, P <.0001; and 0.52 vs. 0.35mV, P<.0001). Binary logistic regression including both measures showed that only immediate pre-defibrillation amplitude remained significantly associated with ROSC while maximal amplitude did not (P =.006 and P =.135). Conclusions Amplitude of the VF waveform at the moment of defibrillation has a strong association with successful defibrillation, ROSC, and SHD.
      Graphical abstract image

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.04.002
  • Revival of Transcatheter PFO Closure: A meta-analysis of randomized
           controlled trials
    • Authors: M. Reinthaler; AK. Ozga; D. Sinning; J. Curio; HSA. Al-Hindwan; J. Baeckemo; F. Jung; A. Lendlein; G. Rauch; U. Landmesser
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): M. Reinthaler, AK. Ozga, D. Sinning, J. Curio, HSA. Al-Hindwan, J. Baeckemo, F. Jung, A. Lendlein, G. Rauch, U. Landmesser
      Background Transcatheter foramen ovale closure (TPC) has emerged as a potential treatment option for patients with cryptogenic strokes and persistent foramen ovale (PFO). However, previous randomized controlled trials could hardly demonstrate any benefit compared to medical treatment (Med-Tx). Recently new data have become available which may change current practice of transcatheter PFO closure. Methods A systematic review and meta-analysis comparing TPC and Med-Tx based on all available multicentric randomized controlled trials was performed. The primary outcome of interest was the recurrence of stroke in both groups. Results Five studies met the inclusion criteria with 1829 patients in the TPC and 1622 in the Med-Tx group. The median follow-up was 4years. In the intention-to-treat analysis we found a statistically significant relative risk reduction in recurrence of strokes in the TPC group compared to the Med-Tx group (pooled hazard ratio (HR): 0.32; 95% CI: 0.13–0.8; P =.018). Excluding one study due to potential publication bias resulted in a pooled HR of 0.48 (95% CI: 0.25–0.91, P =.024). Patients younger than 45years of age (pooled HR: 0.35; 95% CI: 0.16–0.75; P =.007) and those with moderate to severe shunt (pooled HR: 0.28; 95% CI: 0.14–0.55; P <.001) were more likely to benefit from closure. Conclusion According to our meta-analysis TPC plus antiplatelets was superior in terms of stroke prevention when compared to Med-Tx. Furthermore, patients with moderate to severe shunts and those younger than 45years of age were found to benefit most from TPC.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.025
  • The prevalence of pulmonary arterial hypertension before and after atrial
           septal defect closure at adult age: A systematic review
    • Authors: Roxanne D. Zwijnenburg; Vivan J.M. Baggen; Laurie W. Geenen; Kelly R. Voigt; Jolien W. Roos-Hesselink; Annemien E. van den Bosch
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): Roxanne D. Zwijnenburg, Vivan J.M. Baggen, Laurie W. Geenen, Kelly R. Voigt, Jolien W. Roos-Hesselink, Annemien E. van den Bosch

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.020
  • Design of a Phase 3 Trial of Intracoronary Administration of Human
           Adenovirus 5 encoding Human Adenylyl Cyclase Type 6 (RT-100) Gene Transfer
           in Patients with Heart Failure with Reduced Left Ventricular Ejection
           Fraction: The FLOURISH Clinical Trial
    • Authors: William F. Penny; Timothy D. Henry; Matthew W. Watkins; Amit N. Patel; H. Kirk Hammond
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): William F. Penny, Timothy D. Henry, Matthew W. Watkins, Amit N. Patel, H. Kirk Hammond
      The prognosis of patients with HFrEF remains poor despite the use of current medical and device therapies. Preclinical studies of HFrEF using IC delivery of RT-100, a replication deficient, E1/E3-deleted human adenovirus 5 encoding human AC6 was associated with favorable effects on LV function and remodeling. A recent multicenter, double-blind, placebo-controlled, phase 2 study demonstrated the safety of IC delivery of RT-100 in HFrEF patients and potential efficacy at the higher doses. This phase 2 dose finding study, which included doses not expected to be effective, identified a potential reduction in congestive heart failure admissions in the AC6-treated group one year after randomization. The FLOURISH study is designed to investigate the prospect of reduction of heart failure hospitalization and other clinical adverse events and improvement in EF. The FLOURISH study is a double-blind, placebo-controlled, multicenter Phase 3 clinical trial that will randomize 536 patients to a one-time IC administration of RT-100 (1012 vp) or placebo in a 1:1 ratio. Subjects will be 18–80years of age, on optimal standard of care HF therapy with LVEF ≥10% and≤35% by echocardiogram, and will undergo IC administration of RT-100 vs. placebo on Day 1. Follow-up study visits will be performed at Weeks 1 and 4, and Months 3, 6, and 12. Patients will be followed for an additional 36months for safety assessments with telephone contact at Months 24, 36, and 48. The primary objective is to determine the efficacy of IC RT-100 vs. placebo in reducing the event rate of all (first and repeat) HF hospitalizations occurring from baseline to 12months. The secondary objectives are to determine the efficacy of IC RT-100 on CV death, all cause death, and all HF events and in improving NYHA functional classification. Exploratory endpoints will include echocardiographic parameters of left ventricular systolic and diastolic function, HF symptoms and physical limitations, 6-minute walking distance, Borg dyspnea score, and NT-proBNP levels. The FLOURISH study, which received fast track designation from the Food and Drug Administration in December 2017, will further investigate the role of a one-time intracoronary injection of RT-100 in reducing HF hospitalizations and will serve as a registration trial (potentially pivotal investigation) for RT-100 as a treatment for HFrEF.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.04.005
  • Arterio-Ventricular Interaction after Coarctation Repair
    • Authors: Elles J. Dijkema; M.G. Slieker; Tim Leiner; Heynric B. Grotenhuis
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): Elles J. Dijkema, M.G. Slieker, Tim Leiner, Heynric B. Grotenhuis
      Background Hypertension is common in patients with coarctation of the aorta (CoA), even after successful repair. Increased aortic stiffness has been implicated in the pathology of CoA-associated hypertension. This study aimed to investigate aortic vascular function and its relationship with hypertension in well-repaired CoA-patients at long-term follow-up. Furthermore, we assessed the additive effect of hypertension to adverse arterio-ventricular coupling associated with increased aortic stiffness. Methods Twenty-two CoA-patients (age 30±10.6years) with successful surgical repair (n=12) or balloon angioplasty (BA) (n=10) between 3months and 16years of age with a follow-up of >10years and 22 healthy controls underwent cardiac magnetic resonance imaging (CMR), at mean follow-up of 29.3years, to study aortic pulse wave velocity (PWV), aortic distensibility, global left ventricular (LV) function, LV dimensions, and LV myocardial deformation. Results CoA-patients had significantly increased aortic arch PWV (5.6±1.9m/s vs. 4.5±1.0m/s, P =.02) and decreased distensibility (4.5±1.8 x10–3mmHg−1 vs. 5.8±1.8 x10–3mmHg−1, P =.04) compared to controls. Significant differences in aortic arch PWV were found between hypertensive patients, normotensive patients and controls (6.1±1.8m/s vs. 4.9±1.9m/s and 4.5±1.0m/s, respectively, P =.03). Aortic arch PWV and distensibility were correlated with systolic blood pressure (R=0.37 and R=−0.37, respectively, P=.03 for both). Global LV function, LV mass, LV dimensions and myocardial deformation were similar in CoA-patients when compared to controls. Conclusions Central aortic stiffness is significantly increased in well-repaired CoA-patients long-term after repair, and is associated with hypertension. Global LV function, myocardial deformation indices and LV dimensions are however preserved.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.04.004
  • Rationale and design of the comparison of three combination therapies in
           lowering blood pressure in Black Africans (CREOLE study): 2 X 3 factorial
           randomized single-blind multicentre trial
    • Authors: Dike B. Ojji; Neil Poulter; Albertino Damasceno; Karen Sliwa; Wynand Smythe; Nicky Kramer; Motasim Badri; Veronica Francis; Akinyemi Aje; Felix Barasa; Anastase Dzudie; Erika Jones; Abubakar Kana; Mntla Pindile; Charles Mondo; Okechukwu Ogah; Elijah N. Ogola; Gboyega Ogunbanjo; Ikechi Okpechi; Gabriel Shedul; Mahmoud Sani; Grace Shedul; Bongani Mayosi
      Abstract: Publication date: Available online 6 April 2018
      Source:American Heart Journal
      Author(s): Dike B. Ojji, Neil Poulter, Albertino Damasceno, Karen Sliwa, Wynand Smythe, Nicky Kramer, Motasim Badri, Veronica Francis, Akinyemi Aje, Felix Barasa, Anastase Dzudie, Erika Jones, Abubakar Kana, Mntla Pindile, Charles Mondo, Okechukwu Ogah, Elijah N. Ogola, Gboyega Ogunbanjo, Ikechi Okpechi, Gabriel Shedul, Mahmoud Sani, Grace Shedul, Bongani Mayosi
      Background Current hypertension guidelines recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients. Although there are many possible combinations of blood pressure(BP)-lowering therapies, the best combination for the black population is still a subject of debate as no large randomized controlled trials (RCTs) have been conducted in this group to compare the efficacy of different combination therapies to address this issue. Methods The comparison of three combination therapies in lowering BP in Black Africans (CREOLE) study is a randomized single-blind trial that will compare the efficacy of amlodipine plus hydrochlorothiazide, versus amlodipine plus perindopril, and versus perindopril plus hydrochlorothiazide in Blacks residing in sub Saharan Africa (SSA). 702 patients aged 30–79years with a sitting systolic BP of 140mmHg and above, and less than 160mmHg on antihypertensive monotherapy, or sitting systolic BP of 150mmHg and above, and less than 180mmHg on no treatment, will be centrally randomised into any of the three arms (234 into each arm). The CREOLE study is taking place in ten sites in SSA, and the primary outcome measure is change in ambulatory systolic BP (ASBP) from baseline to 6months. The first patient was randomized in June 2017 and the trial will be concluded by 2019. Conclusion The CREOLE trial will provide unique information as to the most efficacious two-drug combination in blacks residing in SSA, and thereby inform the development of clinical guidelines for the treatment of hypertension in this sub region.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.023
  • Comparison of two ambulatory patch ECG monitors: The benefit of the P-
           wave and signal clarity
    • Authors: Robert Rho; Mark Vossler; Susan Blancher ARNP; Jeanne E. Poole
      Abstract: Publication date: Available online 5 April 2018
      Source:American Heart Journal
      Author(s): Robert Rho, Mark Vossler, Susan Blancher ARNP, Jeanne E. Poole

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.022
  • Genetic burden and associations with adverse neurodevelopment in neonates
           with congenital heart disease
    • Authors: Gillian M. Blue; Eddie Ip; Karen Walker; Edwin P. Kirk; Alison Loughran-Fowlds; Gary F. Sholler; Sally L. Dunwoodie; Richard P. Harvey; Eleni Giannoulatou; Nadia Badawi; David S. Winlaw
      Abstract: Publication date: Available online 5 April 2018
      Source:American Heart Journal
      Author(s): Gillian M. Blue, Eddie Ip, Karen Walker, Edwin P. Kirk, Alison Loughran-Fowlds, Gary F. Sholler, Sally L. Dunwoodie, Richard P. Harvey, Eleni Giannoulatou, Nadia Badawi, David S. Winlaw
      Background Up to 20% of children with congenital heart disease (CHD) undergoing cardiac surgery develop neurodevelopmental disabilities (NDD), with some studies reporting persistent impairment. Recent large-scale studies have demonstrated shared genetic mechanisms contributing to CHD and NDD. In this study, a targeted approach was applied to assess direct clinical applicability of this information. Methods A gene panel comprising 148 known CHD and/or NDD genes was used to sequence 15 patients with CHD+NDD, 15 patients with CHD and 15 healthy controls. The number and types of variants between the three groups were compared using Poisson log-linear regression and the SNP-set (Sequence) Kernel Association Test-Optimised was used to conduct single-gene and gene-pathway burden analyses. Results A significant increase in rare (MAF<0.01) and novel variants was identified between the CHD+NDD cohort and controls, P <.001 and P =.001, respectively. There was also a significant increase in rare variants in the CHD cohort compared with controls (P =.04). Rare variant burden analyses implicated pathways associated with ‘neurotransmitters’, ‘axon guidance’ and those incorporating ‘RASopathy’ genes, in the development of NDD in CHD patients. Conclusions These findings suggest that an increase in novel and rare variants in known CHD and/or NDD genes are associated with the development of NDD in patients with CHD. Furthermore, burden analyses point towards rare variant burden specifically in pathways related to brain development and function as contributors to NDD. While promising variants and pathways were identified, further research, utilising whole genome approaches, is required prior to demonstrating clinical utility in this patient group.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.021
  • The Effect of Aliskiren on Exercise Capacity in Older Patients with Heart
           Failure and Preserved Ejection Fraction: A Randomized, Placebo-Controlled,
           Double-Blind Trial
    • Authors: Bharathi Upadhya; Peter H. Brubaker; Timothy M. Morgan; Joel D Eggebeen; Geoffrey T. Jao; Kathryn P. Stewart; Dalane W. Kitzman
      Abstract: Publication date: Available online 4 April 2018
      Source:American Heart Journal
      Author(s): Bharathi Upadhya, Peter H. Brubaker, Timothy M. Morgan, Joel D Eggebeen, Geoffrey T. Jao, Kathryn P. Stewart, Dalane W. Kitzman
      In older patients (70±7years) with chronic well-compensated heart failure with preserved ejection and controlled blood pressure, 6months treatment with aliskiren (direct renin inhibitor) showed non-significant trends for modest improvements in peak exercise oxygen consumption (14.9±0.2ml/kg/min versus 14.4±0.2ml/kg/min; P =.10, trend) and ventilatory anaerobic threshold (888±19m//min versus 841±18ml/min; P =.08).

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.019
  • The Relationship between Baseline and Follow-Up Left Ventricular Ejection
           Fraction with Adverse Events among Primary Prevention ICD Patients
    • Authors: Daniel J. Friedman; Marat Fudim; Robert Overton; Linda K. Shaw; Divyang Patel; Sean D. Pokorney; Eric J. Velazquez; Sana M. Al-Khatib
      Abstract: Publication date: Available online 4 April 2018
      Source:American Heart Journal
      Author(s): Daniel J. Friedman, Marat Fudim, Robert Overton, Linda K. Shaw, Divyang Patel, Sean D. Pokorney, Eric J. Velazquez, Sana M. Al-Khatib
      Background Left ventricular ejection fraction(LVEF) is used to select patients for primary prevention implantable cardioverter defibrillators(ICDs). The relationship between baseline and long-term follow-up LVEF and clinical outcomes among primary prevention ICD patients remains unclear. Methods We studied 195 patients with a baseline LVEF≤35% ≤6months prior to ICD implantation and follow-up LVEF 1–3years after ICD implantation without intervening left ventricular assist device (LVAD) or transplant. The co-primary study endpoints were: (1)a composite of time to death, LVAD, or transplant and (2)appropriate ICD therapy. We examined multivariable Cox proportional hazard models with a 3-year post-implant landmark view; the LVEF closest to the 3-year mark was considered the follow-up LVEF for analyses. Follow-up LVEF was examined using 2 definitions: (1)≥10% improvement compared to baseline or (2)actual value of ≥40%. Results Fifty patients(26%) had a LVEF improvement of ≥10% and 44(23%) had a follow-up LVEF≥40%. Neither baseline nor follow-up LVEF was significantly associated with the composite endpoint. In contrast, both baseline and follow-up LVEF were associated with risk for long-term ICD therapies, whether follow-up LVEF was modeled as a≥10% absolute improvement (baseline LVEF HR 0.87, CI 0.91–0.93, P <.001; follow-up LVEF HR 0.18, CI 0.06–0.53, P =.002) or a≥40% follow-up value (baseline LVEF HR 0.89, CI 0.83–0.96, P =.001, follow-up LVEF HR 0.26, CI 0.08–0.87, P =.03). Conclusions Among primary prevention ICD recipients, both baseline and follow-up LVEF were independently associated with long-term risk for appropriate ICD therapy, but they were not associated with time to the composite of LVAD, transplant, or death.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.03.017
  • Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer
           survivors) Trial
    • Authors: Roberto Bolli; Joshua M. Hare; Timothy D. Henry; Carrie G. Lenneman; Keith March; Kathy Miller; Carl J. Pepine; Emerson C. Perin; Jay H. Traverse; James T. Willerson; Phillip C. Yang; Adrian P. Gee; João A. Lima; Lem Moyé; Rachel W. Vojvodic; Shelly L. Sayre; Judy Bettencourt; Michelle Cohen; Ray F. Ebert; Robert Simari
      Abstract: Publication date: Available online 4 April 2018
      Source:American Heart Journal
      Author(s): Roberto Bolli, Joshua M. Hare, Timothy D. Henry, Carrie G. Lenneman, Keith March, Kathy Miller, Carl J. Pepine, Emerson C. Perin, Jay H. Traverse, James T. Willerson, Phillip C. Yang, Adrian P. Gee, João A. Lima, Lem Moyé, Rachel W. Vojvodic, Shelly L. Sayre, Judy Bettencourt, Michelle Cohen, Ray F. Ebert, Robert Simari
      Objectives SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC). Background AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium. Methods The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a≤30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6months, and 12months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP). Conclusions This is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome.

      PubDate: 2018-04-11T14:48:26Z
      DOI: 10.1016/j.ahj.2018.02.009
  • Intentional and Unintentional Medication Non-Adherence in African
           Americans: Insights from the Jackson Heart Study
    • Authors: Robert J. Mentz; Melissa A. Greiner; Paul Muntner; Daichi Shimbo; Mario Sims; Tanya M. Spruill; Benjamin F. Banahan; Wei Wang; Stanford Mwasongwe; Karen Winters; Adolfo Correa; Lesley H. Curtis; Emily C. O'Brien
      Abstract: Publication date: Available online 12 March 2018
      Source:American Heart Journal
      Author(s): Robert J. Mentz, Melissa A. Greiner, Paul Muntner, Daichi Shimbo, Mario Sims, Tanya M. Spruill, Benjamin F. Banahan, Wei Wang, Stanford Mwasongwe, Karen Winters, Adolfo Correa, Lesley H. Curtis, Emily C. O'Brien
      Background Non-adherence to medications is common and leads to suboptimal outcomes. Non-adherence can be intentional (e.g., deciding to skip dosages) or unintentional (e.g., forgetting), yet few studies have distinguished these reasons. An improved understanding of the reasons for non-adherence could inform the development of effective interventions. Methods and Results We analyzed data from African Americans in the Jackson Heart Study who were prescribed medications for one or more chronic conditions. Participants were grouped by patient-reported adherence with non-adherence categorized as being intentional, unintentional or both. We used modified Poisson regression models to examine the factors associated with types of non-adherence. Of 2933 participants taking medication, 2138 (72.9%) reported non-adherence with 754 (35.3%) reporting only unintentional non-adherence, 263 (12.3%) only intentional non-adherence, and 1121 (52.4%) both. Factors independently associated with intentional non-adherence included female sex and depressive symptoms while factors associated with unintentional non-adherence included younger age and separated relationship status. Unintentional and intentional non-adherence was more common among participants taking anti-arrhythmic and anti-asthmatic medications, respectively. Higher levels of global perceived stress was associated with both types of non-adherence. The adjusted models for intentional and unintentional non-adherence had c-statistics of 0.65 and 0.66, respectively, indicating modest discrimination. Conclusion Specific patient factors and individual medication classes were associated with distinct patterns of intentional and unintentional non-adherence, yet the overall modest discrimination of the models suggests contributions from other unmeasured factors. These findings provide a construct for understanding reasons for non-adherence and provide rationale to assess whether personalized interventions can improve adherence.

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2018.03.007
  • Oral anti-Xa anticoagulation after Trans-Aortic Valve Implantation for
           Aortic Stenosis: The randomized ATLANTIS trial
    • Authors: Jean-Philippe Collet; Sergio Berti Angel Cequier Eric Van Belle Thierry
      Abstract: Publication date: Available online 10 March 2018
      Source:American Heart Journal
      Author(s): Jean-Philippe Collet, Sergio Berti, Angel Cequier, Eric Van Belle, Thierry Lefevre, Pascal Leprince, Franz-Josef Neumann, Eric Vicaut, Gilles Montalescot
      Background Antithrombotic treatment regimen following transcatheter aortic valve replacement (TAVR) is not evidence-based. Apixaban, a non-vitamin K direct anticoagulant (NOAC) was shown to be superior to VKA and superior to aspirin to prevent cardioembolic stroke in non-valvular atrial fibrillation. It may have the potential to reduce TAVR-related thrombotic complications including subclinical valve thrombosis along with a better safety than the standard of care. Design. ATLANTIS is a multicenter, randomized, phase IIIb, prospective, open-label, superiority study comparing standard of care (SOC Group) versus an apixaban-based strategy (Anti-Xa Group) after successful TAVR ( NCT 02664649). Randomization is stratified according to the need for chronic anticoagulation therapy for a reason other than the TAVR procedure. In the experimental arm, patients receive 5mg bid of apixaban or a reduced dose of 2.5mg bid according to the drug label or when apixaban is combined with antiplatelet therapy. In the control arm, patients receive VKA therapy if there is an indication for oral anticoagulation or antiplatelet therapy alone (single or dual) or the combination of both if needed. The primary study end point is the composite of all-cause death, TIA/stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, life-threatening, disabling or major bleeding, according to the Valve Academic Research Consortium definitions. Conclusions ATLANTIS tests the superiority of an apixaban-based strategy versus the recommended standard of care strategy to reduce the risk of post-TAVR thromboembolic and bleeding complications in an all comer population.

      PubDate: 2018-03-17T13:44:21Z
  • Time to therapeutic range and atrial fibrillation
    • Authors: Daniele Pastori; Pasquale Pignatelli Francesco Cribari Roberto Carnevale Mirella Saliola
      Abstract: Publication date: Available online 10 March 2018
      Source:American Heart Journal
      Author(s): Daniele Pastori, Pasquale Pignatelli, Francesco Cribari, Roberto Carnevale, Mirella Saliola, Francesco Violi, Gregory YH Lip
      Background Vitamin K antagonists (VKAs) reduce cardiovascular events (CVEs) in atrial fibrillation (AF) when a time in therapeutic range (TiTR) >70% is achieved. Factors affecting the time to achieve TR (TtTR) are unknown. Methods Prospective observational study including 1406 non-valvular AF patients starting VKAs followed for a mean of 31.3months (3690 patient/year); TiTR, TtTR and SAMe-TT2R2 score were calculated and CVEs were recorded. Results Median TtTR was 8.0days (IQR 5.0–18.0). Patients with high TtTR (i.e. >75th percentile) were more likely to be in AF than in sinus rhythm at entry (Odds ratio, OR:1.423, P =.011). Median TiTR was 60.0%; low TiTR (below median) was associated with SAMe-TT2R2 score (OR:1.175, P =.001), high TtTR (>75th percentile, OR:1.357, P =.017), and number of INR checks (OR:0.998, P =.049). We recorded 113 CVEs (3.1%/year), with a higher rate seen in patients with TtTR >75th percentile compared to those below (log-rank test,P =.006). A multivariable Cox regression analysis showed SAMe-TT2R2 score (HR: 1.331, P <.001), TtTR >75th percentile (HR:1.505, P =.047), TiTR <70% (HR:1.931, P =.004), number of INR checks (HR:0.988, P <.001), digoxin (HR:1.855, P =.008), proton-pump inhibitors (HR:0.452, P<.001), were independently associated with CVEs. Conclusions High TtTR is associated with poorer long-term quality of VKAs therapy. Patients with TtTR >18days or with high SAMe-TT2R2 score should be considered for treatment with non-vitamin K oral anticoagulants.

      PubDate: 2018-03-17T13:44:21Z
  • An Open-label, 2 x 2 Factorial, Randomized Controlled Trial to Evaluate
           the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Placebo in
           Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or
           Percutaneous Coronary Intervention: Rationale and Design of the AUGUSTUS
    • Authors: Renato D. Lopes; Amit N. Vora; Danny Liaw; Christopher B. Granger; Harald Darius; Shaun G. Goodman; Roxana Mehran; Stephan Windecker; John H. Alexander
      Abstract: Publication date: Available online 9 March 2018
      Source:American Heart Journal
      Author(s): Renato D. Lopes, Amit N. Vora, Danny Liaw, Christopher B. Granger, Harald Darius, Shaun G. Goodman, Roxana Mehran, Stephan Windecker, John H. Alexander
      The optimal antithrombotic strategy for patients with atrial fibrillation (AF) who develop acute coronary syndrome (ACS) and/or the need for percutaneous coronary intervention (PCI) is uncertain. The risk of bleeding is a major concern when oral anticoagulation is required to prevent stroke and concomitant therapy with antiplatelet agents is required to minimize recurrent ischemic events. Design AUGUSTUS is an international, multicenter randomized trial with a 2 x 2 factorial design to compare apixaban with vitamin K antagonists (VKAs) and aspirin with placebo in patients with AF who develop ACS and/or undergo PCI and are receiving a P2Y12 inhibitor. Patients will be evaluated for eligibility during their ACS and/or PCI hospitalization. The primary outcome is the composite of major and clinically relevant non-major bleeding defined by the International Society on Thrombosis and Haemostasis. A key secondary outcome is the composite of all-cause death and all-cause hospitalization. Other secondary objectives are to evaluate ischemic outcomes including the composite of death, myocardial infarction, stroke, stent thrombosis, urgent revascularization, and all-cause hospitalization and each individual component. The aim is to enroll approximately 4600 patients from 500 sites in 34 countries. Summary AUGUSTUS will provide insight into the optimal oral antithrombotic therapy strategy for patients with AF and concomitant coronary artery disease. The unique 2 x 2 factorial design will delineate the bleeding effects of various anticoagulant and antiplatelet therapies and generate evidence to guide the selection of the optimal antithrombotic regimen for this challenging group of patients. It is the largest and only prospective randomized trial to investigate in a blinded fashion the risk and benefits of aspirin on top of a non-VKA oral anticoagulant and P2Y12 receptor inhibition.

      PubDate: 2018-03-17T13:44:21Z
      DOI: 10.1016/j.ahj.2018.03.001
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