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Publisher: Elsevier   (Total: 3181 journals)

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Showing 1 - 200 of 3181 Journals sorted alphabetically
Academic Pediatrics     Hybrid Journal   (Followers: 39, SJR: 1.655, CiteScore: 2)
Academic Radiology     Hybrid Journal   (Followers: 26, SJR: 1.015, CiteScore: 2)
Accident Analysis & Prevention     Partially Free   (Followers: 105, SJR: 1.462, CiteScore: 3)
Accounting Forum     Hybrid Journal   (Followers: 28, SJR: 0.932, CiteScore: 2)
Accounting, Organizations and Society     Hybrid Journal   (Followers: 42, SJR: 1.771, CiteScore: 3)
Achievements in the Life Sciences     Open Access   (Followers: 7)
Acta Anaesthesiologica Taiwanica     Open Access   (Followers: 6)
Acta Astronautica     Hybrid Journal   (Followers: 444, SJR: 0.758, CiteScore: 2)
Acta Automatica Sinica     Full-text available via subscription   (Followers: 2)
Acta Biomaterialia     Hybrid Journal   (Followers: 30, SJR: 1.967, CiteScore: 7)
Acta Colombiana de Cuidado Intensivo     Full-text available via subscription   (Followers: 3)
Acta de Investigación Psicológica     Open Access   (Followers: 3)
Acta Ecologica Sinica     Open Access   (Followers: 11, SJR: 0.18, CiteScore: 1)
Acta Histochemica     Hybrid Journal   (Followers: 5, SJR: 0.661, CiteScore: 2)
Acta Materialia     Hybrid Journal   (Followers: 319, SJR: 3.263, CiteScore: 6)
Acta Mathematica Scientia     Full-text available via subscription   (Followers: 5, SJR: 0.504, CiteScore: 1)
Acta Mechanica Solida Sinica     Full-text available via subscription   (Followers: 9, SJR: 0.542, CiteScore: 1)
Acta Oecologica     Hybrid Journal   (Followers: 12, SJR: 0.834, CiteScore: 2)
Acta Otorrinolaringologica (English Edition)     Full-text available via subscription  
Acta Otorrinolaringológica Española     Full-text available via subscription   (Followers: 2, SJR: 0.307, CiteScore: 0)
Acta Pharmaceutica Sinica B     Open Access   (Followers: 2, SJR: 1.793, CiteScore: 6)
Acta Poética     Open Access   (Followers: 4, SJR: 0.101, CiteScore: 0)
Acta Psychologica     Hybrid Journal   (Followers: 26, SJR: 1.331, CiteScore: 2)
Acta Sociológica     Open Access   (Followers: 1)
Acta Tropica     Hybrid Journal   (Followers: 6, SJR: 1.052, CiteScore: 2)
Acta Urológica Portuguesa     Open Access  
Actas Dermo-Sifiliograficas     Full-text available via subscription   (Followers: 3, SJR: 0.374, CiteScore: 1)
Actas Dermo-Sifiliográficas (English Edition)     Full-text available via subscription   (Followers: 2)
Actas Urológicas Españolas     Full-text available via subscription   (Followers: 3, SJR: 0.344, CiteScore: 1)
Actas Urológicas Españolas (English Edition)     Full-text available via subscription   (Followers: 1)
Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 7, SJR: 0.19, CiteScore: 0)
Actualites Pharmaceutiques Hospitalieres     Full-text available via subscription   (Followers: 3)
Acupuncture and Related Therapies     Hybrid Journal   (Followers: 8)
Acute Pain     Full-text available via subscription   (Followers: 15, SJR: 2.671, CiteScore: 5)
Ad Hoc Networks     Hybrid Journal   (Followers: 11, SJR: 0.53, CiteScore: 4)
Addictive Behaviors     Hybrid Journal   (Followers: 18, SJR: 1.29, CiteScore: 3)
Addictive Behaviors Reports     Open Access   (Followers: 9, SJR: 0.755, CiteScore: 2)
Additive Manufacturing     Hybrid Journal   (Followers: 11, SJR: 2.611, CiteScore: 8)
Additives for Polymers     Full-text available via subscription   (Followers: 23)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 188, SJR: 4.09, CiteScore: 13)
Advanced Engineering Informatics     Hybrid Journal   (Followers: 12, SJR: 1.167, CiteScore: 4)
Advanced Powder Technology     Hybrid Journal   (Followers: 17, SJR: 0.694, CiteScore: 3)
Advances in Accounting     Hybrid Journal   (Followers: 9, SJR: 0.277, CiteScore: 1)
Advances in Agronomy     Full-text available via subscription   (Followers: 17, SJR: 2.384, CiteScore: 5)
Advances in Anesthesia     Full-text available via subscription   (Followers: 30, SJR: 0.126, CiteScore: 0)
Advances in Antiviral Drug Design     Full-text available via subscription   (Followers: 2)
Advances in Applied Mathematics     Full-text available via subscription   (Followers: 12, SJR: 0.992, CiteScore: 1)
Advances in Applied Mechanics     Full-text available via subscription   (Followers: 12, SJR: 1.551, CiteScore: 4)
Advances in Applied Microbiology     Full-text available via subscription   (Followers: 24, SJR: 2.089, CiteScore: 5)
Advances In Atomic, Molecular, and Optical Physics     Full-text available via subscription   (Followers: 15, SJR: 0.572, CiteScore: 2)
Advances in Biological Regulation     Hybrid Journal   (Followers: 4, SJR: 2.61, CiteScore: 7)
Advances in Botanical Research     Full-text available via subscription   (Followers: 2, SJR: 0.686, CiteScore: 2)
Advances in Cancer Research     Full-text available via subscription   (Followers: 34, SJR: 3.043, CiteScore: 6)
Advances in Carbohydrate Chemistry and Biochemistry     Full-text available via subscription   (Followers: 9, SJR: 1.453, CiteScore: 2)
Advances in Catalysis     Full-text available via subscription   (Followers: 5, SJR: 1.992, CiteScore: 5)
Advances in Cell Aging and Gerontology     Full-text available via subscription   (Followers: 5)
Advances in Cellular and Molecular Biology of Membranes and Organelles     Full-text available via subscription   (Followers: 14)
Advances in Chemical Engineering     Full-text available via subscription   (Followers: 29, SJR: 0.156, CiteScore: 1)
Advances in Child Development and Behavior     Full-text available via subscription   (Followers: 11, SJR: 0.713, CiteScore: 1)
Advances in Chronic Kidney Disease     Full-text available via subscription   (Followers: 10, SJR: 1.316, CiteScore: 2)
Advances in Clinical Chemistry     Full-text available via subscription   (Followers: 26, SJR: 1.562, CiteScore: 3)
Advances in Colloid and Interface Science     Full-text available via subscription   (Followers: 20, SJR: 1.977, CiteScore: 8)
Advances in Computers     Full-text available via subscription   (Followers: 14, SJR: 0.205, CiteScore: 1)
Advances in Dermatology     Full-text available via subscription   (Followers: 15)
Advances in Developmental Biology     Full-text available via subscription   (Followers: 13)
Advances in Digestive Medicine     Open Access   (Followers: 12)
Advances in DNA Sequence-Specific Agents     Full-text available via subscription   (Followers: 7)
Advances in Drug Research     Full-text available via subscription   (Followers: 26)
Advances in Ecological Research     Full-text available via subscription   (Followers: 44, SJR: 2.524, CiteScore: 4)
Advances in Engineering Software     Hybrid Journal   (Followers: 29, SJR: 1.159, CiteScore: 4)
Advances in Experimental Biology     Full-text available via subscription   (Followers: 8)
Advances in Experimental Social Psychology     Full-text available via subscription   (Followers: 52, SJR: 5.39, CiteScore: 8)
Advances in Exploration Geophysics     Full-text available via subscription   (Followers: 1)
Advances in Fluorine Science     Full-text available via subscription   (Followers: 9)
Advances in Food and Nutrition Research     Full-text available via subscription   (Followers: 67, SJR: 0.591, CiteScore: 2)
Advances in Fuel Cells     Full-text available via subscription   (Followers: 17)
Advances in Genetics     Full-text available via subscription   (Followers: 21, SJR: 1.354, CiteScore: 4)
Advances in Genome Biology     Full-text available via subscription   (Followers: 11, SJR: 12.74, CiteScore: 13)
Advances in Geophysics     Full-text available via subscription   (Followers: 7, SJR: 1.193, CiteScore: 3)
Advances in Heat Transfer     Full-text available via subscription   (Followers: 26, SJR: 0.368, CiteScore: 1)
Advances in Heterocyclic Chemistry     Full-text available via subscription   (Followers: 11, SJR: 0.749, CiteScore: 3)
Advances in Human Factors/Ergonomics     Full-text available via subscription   (Followers: 26)
Advances in Imaging and Electron Physics     Full-text available via subscription   (Followers: 3, SJR: 0.193, CiteScore: 0)
Advances in Immunology     Full-text available via subscription   (Followers: 37, SJR: 4.433, CiteScore: 6)
Advances in Inorganic Chemistry     Full-text available via subscription   (Followers: 10, SJR: 1.163, CiteScore: 2)
Advances in Insect Physiology     Full-text available via subscription   (Followers: 2, SJR: 1.938, CiteScore: 3)
Advances in Integrative Medicine     Hybrid Journal   (Followers: 6, SJR: 0.176, CiteScore: 0)
Advances in Intl. Accounting     Full-text available via subscription   (Followers: 3)
Advances in Life Course Research     Hybrid Journal   (Followers: 9, SJR: 0.682, CiteScore: 2)
Advances in Lipobiology     Full-text available via subscription   (Followers: 1)
Advances in Magnetic and Optical Resonance     Full-text available via subscription   (Followers: 8)
Advances in Marine Biology     Full-text available via subscription   (Followers: 21, SJR: 0.88, CiteScore: 2)
Advances in Mathematics     Full-text available via subscription   (Followers: 15, SJR: 3.027, CiteScore: 2)
Advances in Medical Sciences     Hybrid Journal   (Followers: 8, SJR: 0.694, CiteScore: 2)
Advances in Medicinal Chemistry     Full-text available via subscription   (Followers: 6)
Advances in Microbial Physiology     Full-text available via subscription   (Followers: 5, SJR: 1.158, CiteScore: 3)
Advances in Molecular and Cell Biology     Full-text available via subscription   (Followers: 25)
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: 0.182, CiteScore: 0)
Advances in Nanoporous Materials     Full-text available via subscription   (Followers: 5)
Advances in Oncobiology     Full-text available via subscription   (Followers: 2)
Advances in Organ Biology     Full-text available via subscription   (Followers: 2)
Advances in Organometallic Chemistry     Full-text available via subscription   (Followers: 18, SJR: 1.875, CiteScore: 4)
Advances in Parallel Computing     Full-text available via subscription   (Followers: 7, SJR: 0.174, CiteScore: 0)
Advances in Parasitology     Full-text available via subscription   (Followers: 5, SJR: 1.579, CiteScore: 4)
Advances in Pediatrics     Full-text available via subscription   (Followers: 27, SJR: 0.461, CiteScore: 1)
Advances in Pharmaceutical Sciences     Full-text available via subscription   (Followers: 19)
Advances in Pharmacology     Full-text available via subscription   (Followers: 17, SJR: 1.536, CiteScore: 3)
Advances in Physical Organic Chemistry     Full-text available via subscription   (Followers: 9, SJR: 0.574, CiteScore: 1)
Advances in Phytomedicine     Full-text available via subscription  
Advances in Planar Lipid Bilayers and Liposomes     Full-text available via subscription   (Followers: 3, SJR: 0.109, CiteScore: 1)
Advances in Plant Biochemistry and Molecular Biology     Full-text available via subscription   (Followers: 10)
Advances in Plant Pathology     Full-text available via subscription   (Followers: 6)
Advances in Porous Media     Full-text available via subscription   (Followers: 5)
Advances in Protein Chemistry     Full-text available via subscription   (Followers: 19)
Advances in Protein Chemistry and Structural Biology     Full-text available via subscription   (Followers: 20, SJR: 0.791, CiteScore: 2)
Advances in Psychology     Full-text available via subscription   (Followers: 68)
Advances in Quantum Chemistry     Full-text available via subscription   (Followers: 6, SJR: 0.371, CiteScore: 1)
Advances in Radiation Oncology     Open Access   (Followers: 2, SJR: 0.263, CiteScore: 1)
Advances in Small Animal Medicine and Surgery     Hybrid Journal   (Followers: 3, SJR: 0.101, CiteScore: 0)
Advances in Space Biology and Medicine     Full-text available via subscription   (Followers: 6)
Advances in Space Research     Full-text available via subscription   (Followers: 424, SJR: 0.569, CiteScore: 2)
Advances in Structural Biology     Full-text available via subscription   (Followers: 5)
Advances in Surgery     Full-text available via subscription   (Followers: 13, SJR: 0.555, CiteScore: 2)
Advances in the Study of Behavior     Full-text available via subscription   (Followers: 38, SJR: 2.208, CiteScore: 4)
Advances in Veterinary Medicine     Full-text available via subscription   (Followers: 20)
Advances in Veterinary Science and Comparative Medicine     Full-text available via subscription   (Followers: 15)
Advances in Virus Research     Full-text available via subscription   (Followers: 6, SJR: 2.262, CiteScore: 5)
Advances in Water Resources     Hybrid Journal   (Followers: 54, SJR: 1.551, CiteScore: 3)
Aeolian Research     Hybrid Journal   (Followers: 6, SJR: 1.117, CiteScore: 3)
Aerospace Science and Technology     Hybrid Journal   (Followers: 384, SJR: 0.796, CiteScore: 3)
AEU - Intl. J. of Electronics and Communications     Hybrid Journal   (Followers: 8, SJR: 0.42, CiteScore: 2)
African J. of Emergency Medicine     Open Access   (Followers: 6, SJR: 0.296, CiteScore: 0)
Ageing Research Reviews     Hybrid Journal   (Followers: 12, SJR: 3.671, CiteScore: 9)
Aggression and Violent Behavior     Hybrid Journal   (Followers: 483, SJR: 1.238, CiteScore: 3)
Agri Gene     Hybrid Journal   (Followers: 1, SJR: 0.13, CiteScore: 0)
Agricultural and Forest Meteorology     Hybrid Journal   (Followers: 18, SJR: 1.818, CiteScore: 5)
Agricultural Systems     Hybrid Journal   (Followers: 32, SJR: 1.156, CiteScore: 4)
Agricultural Water Management     Hybrid Journal   (Followers: 45, SJR: 1.272, CiteScore: 3)
Agriculture and Agricultural Science Procedia     Open Access   (Followers: 4)
Agriculture and Natural Resources     Open Access   (Followers: 3)
Agriculture, Ecosystems & Environment     Hybrid Journal   (Followers: 58, SJR: 1.747, CiteScore: 4)
Ain Shams Engineering J.     Open Access   (Followers: 5, SJR: 0.589, CiteScore: 3)
Air Medical J.     Hybrid Journal   (Followers: 8, SJR: 0.26, CiteScore: 0)
AKCE Intl. J. of Graphs and Combinatorics     Open Access   (SJR: 0.19, CiteScore: 0)
Alcohol     Hybrid Journal   (Followers: 12, SJR: 1.153, CiteScore: 3)
Alcoholism and Drug Addiction     Open Access   (Followers: 12)
Alergologia Polska : Polish J. of Allergology     Full-text available via subscription   (Followers: 1)
Alexandria Engineering J.     Open Access   (Followers: 2, SJR: 0.604, CiteScore: 3)
Alexandria J. of Medicine     Open Access   (Followers: 1, SJR: 0.191, CiteScore: 1)
Algal Research     Partially Free   (Followers: 11, SJR: 1.142, CiteScore: 4)
Alkaloids: Chemical and Biological Perspectives     Full-text available via subscription   (Followers: 2)
Allergologia et Immunopathologia     Full-text available via subscription   (Followers: 1, SJR: 0.504, CiteScore: 1)
Allergology Intl.     Open Access   (Followers: 5, SJR: 1.148, CiteScore: 2)
Alpha Omegan     Full-text available via subscription   (SJR: 3.521, CiteScore: 6)
ALTER - European J. of Disability Research / Revue Européenne de Recherche sur le Handicap     Full-text available via subscription   (Followers: 11, SJR: 0.201, CiteScore: 1)
Alzheimer's & Dementia     Hybrid Journal   (Followers: 54, SJR: 4.66, CiteScore: 10)
Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring     Open Access   (Followers: 6, SJR: 1.796, CiteScore: 4)
Alzheimer's & Dementia: Translational Research & Clinical Interventions     Open Access   (Followers: 6, SJR: 1.108, CiteScore: 3)
Ambulatory Pediatrics     Hybrid Journal   (Followers: 5)
American Heart J.     Hybrid Journal   (Followers: 58, SJR: 3.267, CiteScore: 4)
American J. of Cardiology     Hybrid Journal   (Followers: 66, SJR: 1.93, CiteScore: 3)
American J. of Emergency Medicine     Hybrid Journal   (Followers: 47, SJR: 0.604, CiteScore: 1)
American J. of Geriatric Pharmacotherapy     Full-text available via subscription   (Followers: 13)
American J. of Geriatric Psychiatry     Hybrid Journal   (Followers: 14, SJR: 1.524, CiteScore: 3)
American J. of Human Genetics     Hybrid Journal   (Followers: 37, SJR: 7.45, CiteScore: 8)
American J. of Infection Control     Hybrid Journal   (Followers: 29, SJR: 1.062, CiteScore: 2)
American J. of Kidney Diseases     Hybrid Journal   (Followers: 36, SJR: 2.973, CiteScore: 4)
American J. of Medicine     Hybrid Journal   (Followers: 50)
American J. of Medicine Supplements     Full-text available via subscription   (Followers: 3, SJR: 1.967, CiteScore: 2)
American J. of Obstetrics and Gynecology     Hybrid Journal   (Followers: 266, SJR: 2.7, CiteScore: 4)
American J. of Ophthalmology     Hybrid Journal   (Followers: 66, SJR: 3.184, CiteScore: 4)
American J. of Ophthalmology Case Reports     Open Access   (Followers: 5, SJR: 0.265, CiteScore: 0)
American J. of Orthodontics and Dentofacial Orthopedics     Full-text available via subscription   (Followers: 6, SJR: 1.289, CiteScore: 1)
American J. of Otolaryngology     Hybrid Journal   (Followers: 25, SJR: 0.59, CiteScore: 1)
American J. of Pathology     Hybrid Journal   (Followers: 32, SJR: 2.139, CiteScore: 4)
American J. of Preventive Medicine     Hybrid Journal   (Followers: 28, SJR: 2.164, CiteScore: 4)
American J. of Surgery     Hybrid Journal   (Followers: 39, SJR: 1.141, CiteScore: 2)
American J. of the Medical Sciences     Hybrid Journal   (Followers: 12, SJR: 0.767, CiteScore: 1)
Ampersand : An Intl. J. of General and Applied Linguistics     Open Access   (Followers: 7)
Anaerobe     Hybrid Journal   (Followers: 4, SJR: 1.144, CiteScore: 3)
Anaesthesia & Intensive Care Medicine     Full-text available via subscription   (Followers: 67, SJR: 0.138, CiteScore: 0)
Anaesthesia Critical Care & Pain Medicine     Full-text available via subscription   (Followers: 25, SJR: 0.411, CiteScore: 1)
Anales de Cirugia Vascular     Full-text available via subscription   (Followers: 1)
Anales de Pediatría     Full-text available via subscription   (Followers: 3, SJR: 0.277, CiteScore: 0)
Anales de Pediatría (English Edition)     Full-text available via subscription  
Anales de Pediatría Continuada     Full-text available via subscription  
Analytic Methods in Accident Research     Hybrid Journal   (Followers: 5, SJR: 4.849, CiteScore: 10)
Analytica Chimica Acta     Hybrid Journal   (Followers: 44, SJR: 1.512, CiteScore: 5)
Analytica Chimica Acta : X     Open Access  
Analytical Biochemistry     Hybrid Journal   (Followers: 211, SJR: 0.633, CiteScore: 2)
Analytical Chemistry Research     Open Access   (Followers: 13, SJR: 0.411, CiteScore: 2)
Analytical Spectroscopy Library     Full-text available via subscription   (Followers: 14)
Anesthésie & Réanimation     Full-text available via subscription   (Followers: 2)
Anesthesiology Clinics     Full-text available via subscription   (Followers: 25, SJR: 0.683, CiteScore: 2)
Angiología     Full-text available via subscription   (SJR: 0.121, CiteScore: 0)
Angiologia e Cirurgia Vascular     Open Access   (Followers: 1, SJR: 0.111, CiteScore: 0)
Animal Behaviour     Hybrid Journal   (Followers: 227, SJR: 1.58, CiteScore: 3)
Animal Feed Science and Technology     Hybrid Journal   (Followers: 7, SJR: 0.937, CiteScore: 2)
Animal Reproduction Science     Hybrid Journal   (Followers: 7, SJR: 0.704, CiteScore: 2)

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Similar Journals
Journal Cover
American Heart Journal
Journal Prestige (SJR): 3.267
Citation Impact (citeScore): 4
Number of Followers: 58  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 0002-8703 - ISSN (Online) 1097-6744
Published by Elsevier Homepage  [3181 journals]
  • Major bleeding in patients with peripheral artery disease: Insights from
           the EUCLID trial
    • Abstract: Publication date: Available online 18 November 2019Source: American Heart JournalAuthor(s): Rachael Ward, Zhen Huang, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F. Gerry R. Fowkes, Brian G. Katona, Kenneth W. Mahaffey, Lars Norgren, Sreekanth Vemulapalli, Thomas J. Povsic, Rajendra Mehta, William R. Hiatt, Manesh R. Patel, W. Schuyler JonesBackgroundRates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post-hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events.Methods and ResultsEUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety endpoint was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. TIMI major bleeding occurred in 2.3% of participants overall (0.94 events/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and beta-blocker use. Patients with TIMI major bleeding post-randomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40–5.84; P 
       
  • Are existing and emerging biomarkers associated with cardiorespiratory
           fitness in patients with chronic heart failure'
    • Abstract: Publication date: Available online 16 November 2019Source: American Heart JournalAuthor(s): Marat Fudim, Jacob P. Kelly, Aaron D. Jones, Omar AbouEzzeddine, Andrew P. Ambrosy, Stephen J. Greene, Yogesh N.V. Reddy, Kevin J. Anstrom, Brooke Alhanti, Gregory D. Lewis, Adrian F. Hernandez, G. Michael FelkerAimsCardiorespiratory fitness (CRF) is closely linked to health status and clinical outcomes in heart failure (HF) patients. We aimed to test whether biomarkers can reflect CRF and its change over time.Methods and ResultsThis post-hoc analysis utilized data from ambulatory cohorts of heart failure with reduced ejection fraction (HFrEF) (IRONOUT) and heart failure with preserved ejection fraction (HFpEF) (RELAX). Cardiopulmonary exercise testing, 6 minute walk distance (6MWD), and serum biomarkers were measured at baseline and 16 or 24 week follow-up (for IRONOUT and RELAX respectively). Biomarkers included N-terminal pro–B-type natriuretic peptide (NT-proBNP), soluble ST2, growth differentiation factor-15 (GDF-15), and galectin-3. Analysis included 225 patients with HFrEF and 216 with HFpEF. Baseline peak VO2, VE/VCO2 slope and 6MWD showed a mild correlation with the doubling of all four tested biomarkers in HFrEF and HFpEF. Following multivariable adjustment (including all biomarkers), the only significant association between change in biomarker and functional parameter in HFrEF was change in NT-proBNP and change in VE/VCO2 slope (3.596% increase per doubling, 95%CI [0.779, 6.492]; P = .012). In HFpEF a decrease in peak VO2 was associated with an increase in NT-proBNP (−0.726 ml/min/kg per doubling, 95%CI [−1.100, −0.353]; P 
       
  • The accuracy of self-reported blood pressure in the medication adherence
           improvement support app for engagement – Blood pressure (MedISAFE-BP)
           trial: Implications for pragmatic trials
    • Abstract: Publication date: Available online 14 November 2019Source: American Heart JournalAuthor(s): Nancy Haff, Julie C. Lauffenburger, Kyle Morawski, Roya Ghazinouri, Nudrat Noor, Shefali Kumar, Jessie Juusola, Niteesh K. ChoudhrySelf-report of health conditions and behaviors is one potential strategy to increase the pace of enrollment into pragmatic clinical trials. In this study, we assessed the accuracy of self-reported poorly-controlled hypertension among adults in the community who were screened for participation in the MedISAFE-BP trial. Of individuals who self-reported poorly-controlled hypertension using the online trial enrollment platform, 64% had a systolic blood pressure less than 140 mmHg when measured at home. While we identified several characteristics associated with accurate self-report including older age (Odds Ratio [OR] 1.02 per year, 95% CI 1.01–1.03), diabetes (OR 1.59, 95% CI 1.17–2.14), and low health activation (OR 1.56 95% CI 1.17–2.07), we were unable to identify patients for whom self-reported hypertension would be a reliable method for their inclusion in a pragmatic trial.
       
  • The effect of METOPROLOL and aspirin on cardiovascular risk in
           bereavement: A randomized controlled trial
    • Abstract: Publication date: Available online 13 November 2019Source: American Heart JournalAuthor(s): Geoffrey H Tofler, Marie-Christine Morel-Kopp, Monica Spinaze, Jill Dent, Christopher Ward, Sharon McKinley, Anastasia S Mihailidou, Jennifer Havyatt, Victoria Whitfield, Roger Bartrop, Judith Fethney, Holly G Prigerson, Thomas BuckleyBackgroundBereavement is associated with an increased risk of cardiovascular disease; however, no reports exist of interventions to reduce risk. In a randomized, double-blind, placebo-controlled trial of 85 recently bereaved participants, we determined whether beta-blocker (metoprolol 25 mg) and aspirin (100 mg) reduce cardiovascular risk markers and anxiety, without adversely affecting bereavement intensity.MethodsParticipants were spouses (n = 73) or parents (n = 12) of deceased from 5 hospitals in Sydney, Australia, 55 females, 30 males, aged 66.1 ± 9.4 years. After assessment within 2 weeks of bereavement, subjects were randomized to 6 weeks of daily treatment or placebo, and the effect evaluated using ANCOVA, adjusted for baseline values (primary analysis).ResultsParticipants on metoprolol and aspirin had lower levels of home systolic pressure (P = .03), 24-hour average heart rate (P 
       
  • Low-density lipoprotein cholesterol treatment and outcomes in patients
           with type 2 diabetes and established cardiovascular disease: Insights from
           TECOS
    • Abstract: Publication date: Available online 13 November 2019Source: American Heart JournalAuthor(s): Gaetano M. De Ferrari, Susanna R. Stevens, Giuseppe Ambrosio, Sergio Leonardi, Paul W. Armstrong, Jennifer B. Green, Malgorzata Wamil, Rury R. Holman, Eric D. Peterson, on behalf of the TECOS Study GroupBackgroundType 2 diabetes (T2D) patients are at increased risk for cardiovascular (CV) events. Most guidelines recommend treating low-density lipoprotein cholesterol (LDL-C) levels to ≤70 mg/dL (1.8 mM) for patients with T2D and established atherosclerotic CV disease, and some a more aggressive target of ≤55 mg/dL (1.4 mM). Our objective was to assess the degree to which these LDL-C targets are achieved in routine practice.MethodsUsing data from TECOS, an international pragmatic CV outcomes trial of sitagliptin vs placebo, we assessed lipid-lowering treatment among patients with T2D and CV disease, baseline lipid values, and the association between baseline LDL-C and 5-year risk for major adverse cardiac event (MACE; ie, CV death, nonfatal myocardial infarction, or nonfatal stroke).ResultsOverall, 11,066 of 14,671 TECOS participants (75.4%) had LDL-C measured at baseline. Median age was 65 years, 72% were male, and median T2D duration was 10 years. Overall, 82.5% of patients were on statins; only 5.8% were on ezetimibe. At baseline, 14.3% had an LDL-C ≤ 55 mg/dL, 18.4% between 55.1–70 mg/dL, 35% between 70.1–100 mg/dL, and 32.3%>100 mg/dL. Each 10 mg/dL higher LDL-C value was associated with a higher risk of MACE (HR 1.05, 95%CI 1.03–1.07) or CV death (HR 1.06, 95%CI 1.04–1.09).ConclusionsAlthough most high-risk patients with T2D and CV disease were on lipid-lowering therapy, only 1:3 had LDL-C 
       
  • Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed
           dyslipidemia: BEIJERINCK study design and baseline characteristics
    • Abstract: Publication date: Available online 12 November 2019Source: American Heart JournalAuthor(s): Franck Boccara, Princy Kumar, Bruno Caramelli, Alexandra Calmy, J. Antonio G. López, Sarah Bray, Marcoli Cyrille, Robert S. RosensonBackgroundPeople living with human immunodeficiency virus (PLHIV) are at higher risk of atherosclerotic cardiovascular disease (ASCVD) due to traditional and HIV- or antiretroviral treatment (ART)-related risk factors. The use of high-intensity statin therapy is often limited by comorbidities and drug–drug interactions with ART. Herein, we present the design and baseline characteristics of the BEIJERINCK study, which will assess the safety and efficacy of evolocumab in PLHIV and hypercholesterolemia/mixed dyslipidemia.MethodsRandomized, double-blind, placebo-controlled, multinational trial that investigates monthly subcutaneous evolocumab 420 mg versus placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia who are treated with maximally-tolerated statin therapy. The primary outcome is the baseline to week 24 percent change in low density lipoprotein cholesterol (LDL-C). Secondary outcomes include achievement of LDL-C 
       
  • Transcatheter InterAtrial shunt device for the treatment of heart failure:
           Rationale and Design of the Pivotal Randomized Trial to REDUCE elevated
           
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Natalia Berry, Laura Mauri, Ted Feldman, Jan Komtebedde, Dirk J. van Veldhuisen, Scott D. Solomon, Joseph M. Massaro, Sanjiv J. ShahBackgroundA randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study.Study Design and ObjectivesREDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial (LA) pressures. Up to 608 HF patients age ≥ 40 years with LVEF≥40%, PCWP≥25 mmHg during supine ergometer exercise, and PCWP≥5 mmHg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite of (1) cardiovascular mortality or first non-fatal ischemic stroke; (2) HF hospitalizations or healthcare facility visits for intravenous diuresis; and (3) change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, all at 12 months, analyzed by Finkelstein-Schoenfeld methodology. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure.ConclusionsREDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated LA pressure and LVEF≥40%.
       
  • Primary Outcomes Should Be of Primary Interest to Readers
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Matthew Budoff
       
  • Videos to reduce racial disparities in ICD therapy via innovative designs
           (VIVID) trial: Rational, design and methodology
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Kevin L. Thomas, Lonnie T. Sullivan, Sana M. Al-Khatib, Nancy Allen LaPointe, Sam Sears, Andrzej S. Kosinski, Larry R. Jackson, Valentina Kutyifa, Eric D. PetersonBackgroundDespite a higher prevalence of sudden cardiac death (SCD), black individuals are less likely than whites to have an implantable cardioverter defibrillator (ICD) implanted. Racial differences in ICD utilization is in part explained by higher refusal rates in black individuals. Decision support can assist with treatment related uncertainty and prepare patients to make well informed decisions.MethodsThe Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) study will randomize 350 black individuals with a primary prevention indication for an ICD to a racially concordant/discordant video-based decision support tool or usual care. The composite primary outcome is, 1) the decision for ICD placement in the combined video groups compared with usual care and 2) the decision for ICD placement in the racially concordant relative to discordant video group. Additional outcomes include knowledge of ICD therapy and SCD risk, decisional conflict, ICD receipt at 90 days and a qualitative assessment of ICD decision making in acceptors, decliners and those undecided.ConclusionsIn addition to assessing the efficacy of decision support on ICD acceptance among black individuals, VIVID will provide insight into the role of racial concordance in medical decision-making. Given the similarities in the root causes of racial/ethnic disparities in care across health disciplines, our approach and findings may be generalizable to decision-making in other health care settings.
       
  • Primary outcomes should be of primary interest to readers
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Bogdan Enache
       
  • Average daily ischemic vs. bleeding risk in patients with ACS undergoing
           PCI: Insights from the Bleemacs and Renami registries
    • Abstract: Publication date: Available online 11 November 2019Source: American Heart JournalAuthor(s): Fabrizio D'Ascenzo, Carloalberto Biolè, Sergio Raposeiras-Roubin, Federico Gaido, Emad Abu-Assi, Tim Kinnaird, Albert Ariza-Solé, Christoph Liebetrau, Sergio Manzano-Fernández, Giacomo Boccuzzi, Jose Paulo Simao Henriques, Christian Templin, Stephen B. Wilton, Pierluigi Omedè, Lazar Velicki, Ioanna Xanthopoulou, Luis Correia, Enrico Cerrato, Andrea Rognoni, Ugo FabrizioAbstractIntroductionThe risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first-year of follow-up according to clinical presentation, medical and interventional strategies.MethodsBleeMACS and Renami are two multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary endpoints. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup.Results19,826 patients were included. Overall, in the first year after PCI the ADBR was 0.008085%, while ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with STEMI or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the 3rd month, while ADBR became higher, although not significantly, afterwards. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), while non-ST-elevation-ACS patients (NSTE-ACS) and those on ticagrelor had an excess of bleeding (P = .012 and P = .022 respectively).ConclusionsIn unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in STEMI patients and those with incomplete revascularization. In the first year ADIR was higher than ADBR in patients with incomplete revascularization, while ADBR was higher in NSTE-ACS patients and in those discharged on ticagrelor.
       
  • Guideline-directed therapies for comorbidities and clinical outcomes among
           individuals with atrial fibrillation
    • Abstract: Publication date: January 2020Source: American Heart Journal, Volume 219Author(s): Zak Loring, Peter Shrader, Larry A. Allen, Rosalia Blanco, Paul S. Chan, Michael D. Ezekowitz, Gregg C. Fonarow, James V. Freeman, Bernard J. Gersh, Kenneth W. Mahaffey, Gerald V. Naccarelli, Karen Pieper, James A. Reiffel, Daniel E. Singer, Benjamin A. Steinberg, Laine E. Thomas, Eric D. Peterson, Jonathan P. PicciniBackgroundComorbidities are common in patients with atrial fibrillation (AF) and affect prognosis, yet are often undertreated. However, contemporary rates of use of guideline-directed therapies (GDT) for non-AF comorbidities and their association with outcomes are not well described.MethodsWe used the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF) to test the association between GDT for non-AF comorbidities and major adverse cardiac or neurovascular events (MACNE; cardiovascular death, myocardial infarction, stroke/thromboembolism, or new-onset heart failure), all-cause mortality, new-onset heart failure, and AF progression. Adjustment was performed using Cox proportional hazards models and logistic regression.ResultsOnly 6,782 (33%) of the 20,434 patients eligible for 1 or more GDT for non-AF comorbidities received all indicated therapies. Use of all comorbidity-specific GDT was highest for patients with hyperlipidemia (75.6%) and lowest for those with diabetes mellitus (43.1%). Use of “all eligible” GDT was associated with a nonsignificant trend toward lower rates of MACNE (HR 0.90 [0.79-1.02]) and all-cause mortality (HR 0.90 [0.80-1.01]). Use of GDT for heart failure was associated with a lower risk of all-cause mortality (HR 0.77 [0.67-0.89]), and treatment of obstructive sleep apnea was associated with a lower risk of AF progression (OR 0.75 [0.62-0.90]).ConclusionsIn AF patients, there is underuse of GDT for non-AF comorbidities. The association between GDT use and outcomes was strongest in heart failure and obstructive sleep apnea patients where use of GDT was associated with lower mortality and less AF progression.
       
  • High throughout targeted proteomics discovery approach and spontaneous
           reperfusion in ST-segment elevation myocardial infarction
    • Abstract: Publication date: Available online 9 November 2019Source: American Heart JournalAuthor(s): Jay S. Shavadia, Christopher B. Granger, Wendimagegn Alemayehu, Cynthia M. Westerhout, Thomas J. Povsic, Sorin J. Brener, Sean van Diepen, Christopher Defilippi, Paul W. ArmstrongObjectivesTo explore associations between spontaneous reperfusion (SR) in ST-segment elevation myocardial infarction (STEMI) using a multi-marker cardiovascular proteins strategy.BackgroundAlthough SR prior to primary percutaneous coronary intervention (pPCI) is associated with improved outcomes, its pathophysiology remains unclear.MethodsWe evaluated STEMI patients from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI) trial treated with pPCI within 6 hours from symptom onset. SR was core-lab defined as pre-PCI Thrombolysis in Myocardial Infarction (TIMI) flow 2 or 3. Ninety-one cardiovascular disease-related serum biomarkers drawn prior to PCI were analyzed using a high throughput “targeted discovery” panel. Expression levels for individual biomarkers were compared between patients with/without SR. A hierarchical clustering method of biomarkers identified clusters of biomarkers that differentiated the two groups. Associations between individual biomarkers and clusters with SR were further evaluated by multivariable logistic regression.ResultsOf 683 patients studied, 290 had spontaneous reperfusion; those with compared to without SR were more likely non-inferior STEMI, had lower clinical acuity, and lower baseline levels of troponin and creatine kinase. SR was associated with a lower occurrence of 90-day composite of death, heart failure or cardiogenic shock. Fifty-two of 91 individual biomarkers were significantly univariably associated with SR. Forty-five remained significant with adjustment for false discovery rate. Using cluster analysis, 26 biomarkers clusters were identified, explaining 72% of total covariance, and 13 biomarker clusters were significantly associated with SR after multivariable adjustment. SR was associated with higher mean expression levels of proteins in all 13 clusters. The cluster most strongly associated with SR consisted of novel proteins across various distinct, yet inter-linked pathobiological processes (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3 and elafin).ConclusionSpontaneous reperfusion prior to pPCI in STEMI was associated with a lower risk of adverse clinical events. These exploratory data from a targeted discovery proteomics platform identifies novel proteins across diverse, yet complementary, pathobiological axes that show promise in providing mechanistic insights into spontaneous reperfusion in STEMI.Condensed abstractSpontaneous reperfusion has been established with improved STEMI outcomes, yet its pathobiology is unclear and appears to involve diverse physiological processes. Using a 91-biomarker high-throughput proteomics platform, we studied 683 STEMI patients in the APEX AMI trial (290 had core-lab adjudicated pre-PCI TIMI 2/3 flow) and identified 52 proteins that univariably associate with spontaneous reperfusion. Cluster analysis identified 26 biomarker clusters (explaining 72% of total variance), 13 of which, after multivariable adjustment, were significantly associated with spontaneous reperfusion. Four proteins (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3 and elafin) across diverse, yet complementary pathways, appear to be associated most strongly with spontaneous reperfusion.
       
  • The role of clinical assessment and electrophysiology study in Brugada
           Syndrome patients with syncope
    • Abstract: Publication date: Available online 8 November 2019Source: American Heart JournalAuthor(s): Jaime Hernandez-Ojeda, Elena Arbelo, Paloma Jorda, Roger Borras, Oscar Campuzano, Georgia Sarquella-Brugada, Anna Iglesias, Lluis Mont, Ramon Brugada, Josep BrugadaAbstractBackgroundCardiogenic syncope in Brugada syndrome (BrS) increases the risk of major events. Nevertheless, clinical differentiation between cardiogenic and vasovagal syncope can be challenging. We characterized the long-term incidence of major events in a large cohort of BrS patients presented with syncope.MethodsFrom a total of 474 patients, syncope was the initial manifestation in 135 (28.5%) individuals (43.9 ± 13.9 years, 71.1% male). The syncope was classified prospectively in cardiogenic, vasovagal or undefined if unclear characteristics were present. Clinical, electrocardiographic, genetic and electrophysiologic features were analyzed. Cardiogenic syncope, sustained ventricular arrhythmias and sudden death were considered major events in follow-up.ResultsIn 66 patients (48.9%) the syncope was cardiogenic, in 51 (37.8%) vasovagal and in 18 (13.3%) undefined. The electrophysiology study (EPS) inducibility was more frequent in patients with cardiogenic syncope and absent in all patients with undefined syncope (28[53.8%] vs. 5[12.2%] vs 0[0%]; P 
       
  • Clinical and regulatory landscape for cardiogenic shock: A report from the
           Cardiac Safety Research Consortium ThinkTank on cardiogenic shock
    • Abstract: Publication date: January 2020Source: American Heart Journal, Volume 219Author(s): Marc Samsky, Mitchell Krucoff, Andrew D. Althouse, William T. Abraham, Philip Adamson, Fernando Aguel, Seth Bilazarian, George D. Dangas, Ian C Gilchrist, Timothy D. Henry, Judith S. Hochman, Navin K. Kapur, John Laschinger, Roy G. Masters, Eric Michelson, David A. Morrow, Valarie Morrow, E. Magnus Ohman, Ileana Pina, Alastair G. Proudfoot
       
  • Sudden cardiac death in patients with Myocarditis: Evaluation, risk
           stratification, and management
    • Abstract: Publication date: Available online 15 August 2019Source: American Heart JournalAuthor(s): Fatima Ali-Ahmed, Frederik Dalgaard, Sana M. Al-KhatibAbstractMyocarditis is a major cause of sudden cardiac death (SCD) and dilated cardiomyopathy (DCM) in young adults. Cardiac magnetic resonance (CMR) is the established tool for the diagnosis of myocarditis, and late gadolinium enhancement (LGE) detected on CMR imaging is the strongest independent predictor of SCD, all-cause mortality, and cardiac mortality. Several other factors have been associated with SCD or cardiac transplantation including New York Heart Association functional class III/IV, reduced left ventricular ejection fraction (LVEF)
       
  • Getting to an improved understanding of low-density
           lipoprotein-cholesterol and dyslipidemia management (GOULD): Methods and
           baseline data of a registry of high cardiovascular risk patients in the
           United States
    • Abstract: Publication date: Available online 31 October 2019Source: American Heart JournalAuthor(s): Christopher P. Cannon, James A. de Lemos, Robert S. Rosenson, Christie M. Ballantyne, Yuyin Liu, Daniel Yazdi, Mary Elliott-Davey, Katherine E. Mues, Deepak L. Bhatt, Mikhail N. Kosiborod, GOULD InvestigatorsAbstractBackgroundGuidelines for managing patients with atherosclerotic cardiovascular disease (ASCVD) recommend statin therapy initially. Target levels/goals for low-density lipoprotein-cholesterol (LDL-C) were initially included, subsequently de-emphasized in 2013, and then re-introduced as thresholds, leading to confusion in clinical practice. We designed a multicenter, observational registry of patients with ASCVD, to describe and track LDL-C treatment patterns in the United States over time.MethodsPatients with ASCVD receiving any pharmacologic lipid-lowering therapy were eligible for enrollment in one of three cohorts: 1) currently receiving a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), or not receiving PCSK9i with 2) LDL-C 70–99 mg/dL, or 3) LDL-C ≥ 100 mg/dL. Patients undergo a 1-year retrospective chart review, followed by chart reviews and phone interviews every 6 months for 2 years.ResultsA total of 5006 patients were enrolled at 119 centers. Mean age was 68 years, 40% of patients were female, 86% were white, 80% had coronary artery disease, and 33% had type 2 diabetes mellitus. Among those not on a PCSK9i, high-intensity statins and ezetimibe were utilized in only 44% and 9%, respectively. Among women vs men, only 36.6% vs 48.2% received high-intensity statins (P 
       
  • Gastrointestinal bleeding in patients with atrial fibrillation treated
           with Apixaban or warfarin: Insights from the ARISTOTLE trial
    • Abstract: Publication date: Available online 31 October 2019Source: American Heart JournalAuthor(s): David A. Garcia, Deborah A. Fisher, Hillary Mulder, Lisa Wruck, Raffele De Caterina, Sigrun Halvorsen, Christopher B. Granger, Claes Held, Lars Wallentin, John H. Alexander, Renato D. LopesAbstractObjectivesA history of gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) may impact decisions about anticoagulation treatment. To sought to determine whether prior GIB in patients with AF taking anticoagulants was associated with an increased risk of stroke or major hemorrhage.MethodsWe analyzed key efficacy and safety outcomes in patients with prior GIB in ARISTOTLE. Centrally adjudicated outcomes according to GIB history were analyzed using Cox proportional hazards models adjusted for randomized treatment and established risk factors.ResultsA total of 784 (4.3%) patients had prior GIB (321 [41%] lower, 463 [59%] upper); 215 (27%) occurred
       
  • Impact Of Initial Heart Failure Emergence On Clinical Outcomes Of Atrial
           Fibrillation Patients In the AFFIRM Trial
    • Abstract: Publication date: Available online 28 October 2019Source: American Heart JournalAuthor(s): April Slee, Sanjeev SaksenaAbstractBackgroundHeart failure (HF) emergence in atrial fibrillation (AF) patients undergoing different treatment strategies has not been studied.MethodsAFFIRM trial subjects with no history of HF, without clinical HF & normal left ventricular ejection fraction at enrollment were identified. The principal outcome was time to development of a composite of NYHA class ≥II HF &/or cardiovascular (CV) death. It was compared for Rate and Rhythm strategies and correlated with ECG parameters on follow up (FU).Results1771 patients (880 Rate, 891 Rhythm) were evaluated. The principal outcome occurred in 21.4% of Rate and 16.8% of Rhythm subjects at 5 years (HR 1.32, 95% confidence intervals {CI:} 1.04, 1.69, P = .024). HF inrement by 2 classes increased total mortality (HR 2.83, 95% CI 1.91, 4.18, P 
       
  • ECG AI-guided screening for low ejection fraction (EAGLE): Rationale and
           design of a pragmatic cluster randomized trial
    • Abstract: Publication date: Available online 25 October 2019Source: American Heart JournalAuthor(s): Xiaoxi Yao, Rozalina G. McCoy, Paul A. Friedman, Nilay D. Shah, Barbara A. Barry, Emma M. Behnken, Jonathan W. Inselman, Zachi I. Attia, Peter A. NoseworthyAbstractBackgroundA deep learning algorithm to detect low ejection fraction (EF) using routine 12-lead electrocardiogram (ECG) has recently been developed and validated. The algorithm was incorporated into the electronic health record (EHR) to automatically screen for low EF, encouraging clinicians to obtain a confirmatory transthoracic echocardiogram (TTE) for previously undiagnosed patients, thereby facilitating early diagnosis and treatment.ObjectivesTo prospectively evaluate a novel artificial intelligence (AI) screening tool for detecting low EF in primary care practices.Design.The EAGLE trial is a pragmatic two-arm cluster randomized trial (NCT04000087) that will randomize>100 clinical teams (i.e., clusters) to either intervention (access to the new AI screening tool) or control (usual care) at 48 primary care practices across Minnesota and Wisconsin. The trial is expected to involve approximately 400 clinicians and 20,000 patients. The primary endpoint is newly discovered EF ≤ 50%. Eligible patients will include adults who undergo ECG for any reason and have not been previously diagnosed with low EF. Data will be pulled from the EHR, and no contact will be made with patients. A positive deviance qualitative study and a post-implementation survey will be conducted among select clinicians to identify facilitators and barriers to using the new screening report.SummaryThis trial will examine the effectiveness of the AI-enabled ECG for detection of asymptomatic low EF in routine primary care practices and will be among the first to prospectively evaluate the value of AI in real-world practice. Its findings will inform future implementation strategies for the translation of other AI-enabled algorithms.
       
  • Patterns of Amiodarone use and outcomes in clinical practice for atrial
           fibrillation
    • Abstract: Publication date: Available online 23 October 2019Source: American Heart JournalAuthor(s): Sean D. Pokorney, DaJuanicia N. Holmes, Peter Shrader, Laine Thomas, Gregg C. Fonarow, Kenneth W. Mahaffey, Bernard J Gersh, Peter R. Kowey, Gerald V. Naccarelli, James V. Freeman, Daniel E. Singer, Jeffrey B. Washam, Eric D. Peterson, Jonathan P. Piccini, James A. ReiffelAbstractBackgroundAmiodarone is the most effective antiarrhythmic drug (AAD) for atrial fibrillation (AF), but it has a high incidence of adverse effects.MethodsUsing the ORBIT AF registry, patients with AF on amiodarone at enrollment, prescribed amiodarone during follow-up, or never on amiodarone were analyzed for the proportion treated with a guideline-based indication for amiodarone, the variability in amiodarone use across sites, and the outcomes (mortality, hospitalization, and stroke) among patients treated with amiodarone. Hierarchical logistic regression modeling with site-specific random intercepts compared rates of amiodarone use across 170 sites. A logistic regression model for propensity to receive amiodarone created a propensity-matched cohort. Cox proportional hazards modeling, stratified by matched pairs evaluated the association between amiodarone and outcomes.ResultsAmong 6987 AF patients, 867 (12%) were on amiodarone at baseline and 451 (6%) started on incident amiodarone during the 3-year follow-up. Use of amiodarone varied among sites from 3% in the lowest tertile to 21% in the highest (P 
       
  • Care Optimization Through Patient and Hospital Engagement Clinical Trial
           for Heart Failure: Rationale and Design of CONNECT-HF
    • Abstract: Publication date: Available online 23 October 2019Source: American Heart JournalAuthor(s): Adam D. DeVore, Bradi B. Granger, Gregg C. Fonarow, Hussein R. Al-Khalidi, Nancy M. Albert, Eldrin F. Lewis, Javed Butler, Ileana L. Piña, Paul A. Heidenreich, Larry A. Allen, Cyde W. Yancy, Lauren B. Cooper, G. Michael Felker, Lisa A. Kaltenbach, A. Thomas McRae, David E. Lanfear, Robert W. Harrison, Robb D. Kociol, Maghee Disch, Dan ArielyAbstractMany therapies have been shown to improve outcomes for patients with heart failure (HF) in controlled settings, but there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF (Care Optimization Through Patient and Hospital Engagement Clinical Trial for HF) study is a prospective, cluster-randomized trial of 161 hospitals in the United States with a 2x2 factorial design. The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective). The hospital and post-discharge intervention includes audit and feedback on HF clinical process measures and outcomes for patients with HF with reduced ejection fraction (HFrEF) paired with education to sites and clinicians by a trained, nationally representative group of HF and quality improvement experts. The patient-level digital intervention is an optional ancillary study and includes a mobile application and behavioral tools that are intended to facilitate improved use of guideline-directed recommendations for self-monitoring and self-management of activity and medications for HFrEF. The effects of the interventions will be measured through an opportunity-based composite score on quality and time-to-first HF readmission or death among patients with HFrEF who present to study hospitals with acute HF and who consent to participate. The CONNECT-HF study is evaluating approaches for implementing HF guideline recommendations into practice and is one of the largest HF implementation science trials performed to date.Trial Registrationclinicaltrials.gov Identifier: NCT03035474
       
  • Age, knowledge, preferences, and risk tolerance for invasive cardiac care
    • Abstract: Publication date: Available online 23 October 2019Source: American Heart JournalAuthor(s): Michael G. Nanna, Eric D. Peterson, Angie Wu, Tina Harding, Anthony N. Galanos, Lisa Wruck, Karen P. AlexanderAbstractBackground/objectivesThe extent to which individual knowledge, preferences, and priorities explain lower use of invasive cardiac care among older vs. younger adults presenting with acute coronary syndrome (ACS) is unknown. We directly surveyed a group of patients to ascertain their preferences and priorities for invasive cardiovascular care.DesignWe performed a prospective cohort study of adults hospitalized with ACS. We surveyed participants regarding their knowledge, preferences, goals, and concerns for cardiac care, as well as their risk tolerance for coronary artery bypass grafting (CABG).SettingSingle academic medical center.Participants628 participants (373
       
  • Outcome impact of different tranexamic acid regimens in cardiac surgery
           with cardiopulmonary bypass (OPTIMAL): Rationale, design, and study
           protocol of a multi-center randomized controlled trial
    • Abstract: Publication date: Available online 21 October 2019Source: American Heart JournalAuthor(s): Jia Shi, Chenghui Zhou, Sheng Liu, Hansong Sun, Yang Wang, Fuxia Yan, Wei Pan, Zhe ZhengAbstractBackgroundTranexamic acid (TxA) reduces perioperative blood transfusion in cardiac surgery; however, the optimal dose of TxA remains unknown.Methods and ResultsThis large-scale, double-blind, randomized controlled trial with a 1-year follow-up enrolls patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients are randomly assigned 1:1 into either the high-dose TxA group (intravenous bolus [30 mg/kg] after anesthesia followed by intravenous maintenance [16 mg/kg/hour] throughout the operation, and a pump prime dose of 2 mg/kg) or the low-dose TxA group (intravenous bolus and maintenance are 10 mg/kg and 2 mg/kg/hour, respectively, and a pump prime dose of 1 mg/kg). The primary efficacy endpoint is the rate of perioperative allogeneic red blood cell (RBC) transfusion defined as the number (%) of patients who will receive at least one RBC unit from operation day to discharge. The primary safety endpoint is the 30-day rate of the composite of perioperative seizures, renal dysfunction, myocardial infarction, ischemic stroke, deep vein thrombosis, pulmonary embolism, and all-cause mortality. The secondary endpoints are perioperative allogeneic RBC transfusion volume, the non-RBC blood transfusion rate, postoperative bleeding, reoperation rate, mechanical ventilation duration, ICU stay, hospital length of stay, total hospitalization cost, each component of composite primary safety endpoint, and the 6-month/1-year follow-up mortality and morbidity. We estimated a sample size of 3,008 participants.ConclusionsThe study is designed to identify a TxA dose with maximal efficacy and minimal complications. We hypothesize that the high dose has superior efficacy and non-inferior safety to the low dose.
       
  • “Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA):
           Safety and efficacy of low-dose Iloprost, a prostacyclin analogue, in
           addition to standard therapy, as compared to standard therapy alone, in
           post-cardiac-arrest-syndrome patients.”
    • Abstract: Publication date: Available online 21 October 2019Source: American Heart JournalAuthor(s): Anna S.P. Meyer, Per I. Johansson, Jesper Kjaergaard, Martin Frydland, Martin A.S. Meyer, Hanne Hee Henriksen, Jakob H. Thomsen, Sebastian C. Wiberg, Christian Hassager, Sisse R. OstrowskiAbstractObjectiveAn increasingly recognized prognostic factor for out-of-hospital-cardiac-arrest (OHCA) patients is the ischemia-reperfusion injury after restored blood circulation. Endothelial injury is common in patients resuscitated from cardiac arrest and is associated with poor outcome. This study was designed to investigate if iloprost infusion, a prostacyclin analogue, reduces endothelial damage in OHCA patients.Methods50 patients were randomized in a placebo controlled double-blinded trial and allocated 1:2 to 48-hours iloprost infusion, (1 ng/kg/min) or placebo (saline infusion). Endothelial biomarkers (soluble thrombomodulin (sTM), sE-selectin, syndecan-1, soluble vascular endothelial growth factor (sVEGF), vascular endothelial cadherine (VEcad), nucleosomes) and sympathoadrenal activation (epinephrine/norepinephrine) from baseline to 48 and 96-hours were evaluated.ResultsIloprost infusion did not influence endothelial biomarkers by the 48-hour endpoint. A rebound effect was observed with higher biomarker plasma values in the iloprost group (sTM p=0.02; Syndecan p=0.004; nucleosomes p
       
  • Incidence and predictors of atrial fibrillation episodes as detected by
           implantable loop recorder in patients at risk From the LOOP study
    • Abstract: Publication date: Available online 20 October 2019Source: American Heart JournalAuthor(s): Søren Zöga Diederichsen, Ketil Jørgen Haugan, Axel Brandes, Claus Graff, Derk Krieger, Christian Kronborg, Anders Gaarsdal Holst, Jonas Bille Nielsen, Lars Køber, Søren Højberg, Jesper Hastrup SvendsenAbstractBackgroundRecent studies have suggested a high prevalence of subclinical atrial fibrillation (AF) in various patient populations, and interest in AF screening has increased. However, knowledge about episode-duration is scarce, and risk factors for short or long subclinical AF episodes have yet to be recognized.AimsTo assess AF by long-term continuous screening, and to investigate predictors of episodes lasting ≥6 minutes, ≥5.5 hours or ≥ 24 hours, respectively.MethodsA total of 597 patients aged ≥70 years and diagnosed with ≥1 of hypertension, diabetes, previous stroke, or heart failure, were recruited from the general population to receive implantable loop recorder with remote monitoring. Exclusion criteria included history of AF or cardiac implantable electronic device. AF episodes were adjudicated by senior cardiologists.ResultsDuring 40 [37;42] months of continuous monitoring, AF was detected in 209 (35%) of the patients. The cumulative incidences at 3 years were 33.8 (30.2–37.8), 16.1 (13.4–19.4), and 5.7 (4.1–7.9) % for AF episodes lasting ≥6 minutes, ≥5.5 hours and ≥ 24 hours, respectively. Slower resting sinus rate and higher body mass index, NT-proBNP, and troponin T at baseline were independently associated with AF detection. Addition of these markers to a model of sex, age, and comorbidities improved prediction of AF episodes ≥24 hours (time-dependent area under the receiver operating characteristic curve 79% vs. 65%, P = .037).ConclusionA considerable burden of previously unknown AF was detected when long-term monitoring was applied in at-risk patients. Biomarkers were associated with AF incidence and improved prediction of long AF episodes.
       
  • Association of obesity with cardiovascular outcomes in patients with type
           2 diabetes and cardiovascular disease: Insights from TECOS
    • Abstract: Publication date: Available online 20 October 2019Source: American Heart JournalAuthor(s): Neha J. Pagidipati, Yinggan Zheng, Jennifer B. Green, Darren K. McGuire, Robert J. Mentz, Svati Shah, Pablo Aschner, Tuncay Delibasi, Helena W. Rodbard, Cynthia M. Westerhout, Rury R. Holman, Eric D. Peterson, on behalf of the TECOS Study GroupAbstractBackgroundObesity is a risk factor for type 2 diabetes (T2D) and cardiovascular disease (CVD). Whether obesity affects outcomes among those with T2D and atherosclerotic CVD (ASCVD) remains uncertain. Our objective was to investigate the relationship between body mass index (BMI) and ASCVD outcomes among TECOS participants with T2D and ASCVD.MethodsBMI categories were defined as underweight/normal weight (BMI
       
  • Sex-specific Cardiac Phenotype and Clinical Outcomes in Patients with
           Hypertrophic Cardiomyopathy
    • Abstract: Publication date: Available online 20 October 2019Source: American Heart JournalAuthor(s): Dai-Yin Lu, Ioannis Ventoulis, Hongyun Liu, Shibani M. Kudchadkar, Gabriela V. Greenland, Hulya Yalcin, Effrosyni Kontari, Sagar Goyal, Celia P. Corona-Villalobos, Styliani Vakrou, Stefan L. Zimmerman, Theodore P. Abraham, M. Roselle AbrahamBackgroundIt is unknown whether sex-specific differences in mortality observed in HCM are due to older age of women at presentation, or whether women have greater degree of LV myopathy than men.MethodsWe retrospectively compared clinical/imaging characteristics and outcomes between women and men in our overall cohort composed of 728 HCM patients, and in an age-matched subgroup comprised of 400 age-matched patients. We examined sex-specific differences in LV myopathy, and dissected the influence of age and sex on outcomes. LV myopathy was assessed by measuring LV mass, LVEF, global peak longitudinal systolic strain (LV-GLS), diastolic function (E/A, E/e'), late gadolinium enhancement (LV-LGE) and myocardial blood flow(MBF) at rest/stress. The primary endpoint was a composite outcome, comprising heart failure (HF), atrial fibrillation (AFib), ventricular tachycardia/fibrillation (VT/VF) and death; individual outcomes were defined as the secondary endpoint.ResultsWomen in the overall cohort were older by 6 years. Women were more symptomatic and more likely to have obstructive HCM. Women had smaller LV cavity size, stroke volume and LV mass, higher indexed maximum wall thickness (IMWT), more hyperdynamic LVEF and higher/similar LV-GLS. Women had similar LV-LGE and E/A, but higher E/e' and rest/stress MBF. Female sex was independently associated with the composite outcome in the overall cohort, and with HF in the overall cohort and age-matched subgroup after adjusting for obstructive HCM, LA diameter, LV-GLS.ConclusionsOur results suggest that sex-specific differences in LV geometry, hyper-contractility and diastolic function, not greater degree of LV myopathy, contribute to a higher, age-independent risk of diastolic HF in women with HCM.Graphical abstractUnlabelled Image
       
  • Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS-
           RCT)
    • Abstract: Publication date: Available online 20 October 2019Source: American Heart JournalAuthor(s): David Birnie, Rob S.B. Beanlands, Pablo Nery, Shawn D. Aaron, Daniel A. Culver, Robert A. DeKemp, Lorne Gula, Andrew Ha, Jeffery S. Healey, Yuko Inoue, Mark A. Judson, Daniel Juneau, Kengo Kusano, Russell Quinn, Lena Rivard, Mustafa Toma, Amanda Varnava, George Wells, Melissa Wickremasinghe, Jordana KronAbstractBackgroundApproximately 5% of patients with sarcoidosis have clinically manifest cardiac involvement. Clinical features of Cardiac Sarcoidosis are dependent on the location, extent, and activity of the disease. First line therapy is usually with prednisone and this is recommended based on clinician experience, expert opinion and small observational cohorts. There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions. Corticosteroid are associated with multiple adverse effects including hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections. In contrast Methotrexate is generally well tolerated and is increasingly used in other forms of sarcoidosis.ObjectivesThe Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS-RCT; NCT03593759) is a multicenter randomized controlled trial designed to evaluate the optimal initial treatment strategy for patients with active cardiac sarcoidosis. We hypothesize that (1) a low dose prednisone/methotrexate combination will have non-inferior efficacy to standard dose prednisone and that (2) the low dose prednisone/ methotrexate combination will result in significantly better quality of life than standard dose prednisone, as a result of reduced burden of side effects.Methods/DesignEligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction. Subjects will be randomized in a 1:1 ratio to prednisone 0.5 mg/kg/day for 6 months (maximum dose 30 mg daily) OR to prednisone 20 mg daily for 1 month, then 10 mg daily for 1 month, then 5 mg daily for one month then stop AND methotrexate 15–20 mg once weekly for 6 months. The primary endpoint is summed perfusion rest score on 6-month PET (blinded core-lab review). The summed perfusion rest score is measure of myocardial fibrosis/scar. The design is non-inferiority with a sample size of 97 per group.DiscussionGiven the multiorgan system potential adverse side effects of prednisone, proving noninferiority of an alternate regimen would be sufficient to make the alternative compare favorably to standard dose steroids. This is the first ever clinical trial in cardiac sarcoidosis and thus in addition to the listed goals of the trial, we will also establish a multi-center, multinational cardiac sarcoidosis clinical trials network. Such a collaborative infrastructure will enable a new era of high quality data to guide physicians when treating cardiac sarcoidosis patients.
       
  • Grenada heart project- community health ActioN to EncouraGe healthy
           BEhaviors (GHP–CHANGE): A randomized control peer group based lifestyle
           intervention
    • Abstract: Publication date: Available online 4 September 2019Source: American Heart JournalAuthor(s): Jacqueline Latina, Rodrigo Fernandez-Jimenez, Sameer Bansilal, Samantha Sartori, Rajesh Vedanthan, Marcelle Lewis, Claire Kofler, Marilyn Hunn, Francis Martin, Emilia Bagiella, Michael Farkouh, Valentin FusterAbstractBackgroundThe incidence of cardiovascular (CV) risk factors is increasing globally, with a disproportionate burden in the low and low-middle income countries (L/LMICs). Peer support, as a low-cost lifestyle intervention, has succeeded in managing chronic illness. For global CV risk reduction, limited data exists in LMICs.AimThe Grenada Heart Project- Community Health ActioN to EncouraGe Healthy BEhaviors (GHP-CHANGE) was designed as a community-based randomized trial to test the effectiveness of peer support strategy for CV risk reduction in the island of Grenada, a LMIC.MethodsWe recruited 402 adults from the Grenada Heart Project (GHP) Cohort Study of 2827 subjects with at least two CV risk factors. Subjects were randomized in a 1:1 fashion to a peer-group based intervention group (n = 206) or a self-management control group (n = 196) for 12 months. The primary outcome was the change from baseline in a composite score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (FBS, Fuster-BEWAT Score), ranging from 0 to 15 (ideal health = 15). Linear mixed-effects models were used to test for intervention effects.ResultsParticipants mean age was 51.4 years (SD 14.5) years, two-thirds were female, and baseline mean FBS was 8.9 (SD 2.6) and 8.5 (SD 2.6) in the intervention and control group, respectively (P = .152). At post intervention, the mean FBS was higher in the intervention group compared to the control group [9.1 (SD 2.7) vs 8.5 (SD 2.6), P = .028]. When balancing baseline health profile, the between-group difference (intervention vs. control) in the change of FBS was 0.31 points (95% CI: −0.12 to 0.75; P = .154).ConclusionsThe GHP-CHANGE trial showed that a peer-support lifestyle intervention program was feasible; however, it did not demonstrate a significant improvement in the FBS as compared to the control group. Further studies should assess the effects of low-cost lifestyle interventions in LMICs.
       
  • Clinical research study implementation of case-finding strategies for
           heart failure and chronic obstructive pulmonary disease in the elderly
           with reduced exercise tolerance or dyspnoea: A cluster randomized trial
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Yvonne van Mourik, Frans H. Rutten, Loes C.M. Bertens, Maarten J.M. Cramer, Jan-Willem J. Lammers, Aisha Gohar, Johannes B. Reitsma, Karel G.M. Moons, Arno W. HoesAbstractBackgroundHeart failure (HF) and chronic obstructive pulmonary disease (COPD) often remain undiagnosed in older individuals, while both disorders inhibit functionality and impair health.AimTo assess the effectiveness of a case-finding strategy of these disorders.Design and settingClustered randomized trial; eighteen general practices from the vicinity of Utrecht, the Netherlands, were randomly allocated to a case-finding strategy or usual care.MethodsMultimorbid community subjects (≥65 years) with dyspnoea or reduced exercise tolerance were eligible for inclusion. The case-finding strategy consisted of history taking, physical examination, blood tests, electrocardiography, spirometry and echocardiography. Subsequent treatment decisions were at the discretion of the general practitioner. Questionnaires regarding health status and functionality were filled out at baseline and after six months of follow-up. Information regarding changes in medication and health care use during the six months follow-up was extracted.Results829 participants were randomized; 389 in the case-finding strategy group and 440 in the usual care group. More patients in the case-finding group received a new diagnosis of HF or COPD than the usual care group (cumulative incidence 34% vs. 2%, and 17% vs. 2%, respectively). Scores for health status, functionality, and health care use were similar between the two strategies after six months of follow-up.ConclusionA case-finding strategy applied in primary care to multimorbid older people with dyspnoea or reduced exercise tolerance resulted in a number of new diagnoses of HF and COPD, but did not result in short-term improvement of health status compared to usual care.Trial registration.ClinicalTrials.gov NCT01148719
       
  • Distal evaluation of functional performance with intravascular sensors to
           assess the narrowing effect – Combined pressure and Doppler FLOW
           velocity measurements (DEFINE-FLOW) trial: Rationale and trial design
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Valérie E. Stegehuis, Gilbert W.M. Wijntjens, Tim P. van de Hoef, Lorena Casadonte, Richard L. Kirkeeide, Maria Siebes, Jos A.E. Spaan, K. Lance Gould, Nils P. Johnson, Jan J. PiekAbstractBackgroundIt remains uncertain if invasive coronary physiology beyond fractional flow reserve (FFR) can refine lesion selection for revascularization or provide additional prognostic value. Coronary flow reserve (CFR) equals the ratio of hyperemic to baseline flow velocity and has a wealth of invasive and non-invasive data supporting its validity. Due to fundamental physiologic relationships, binary classification of FFR and CFR disagree in approximately 30–40% of cases. Optimal management of these discordant cases requires further study.AimTo determine the prognostic value of combined FFR and CFR measurements to predict the 24-month rate of major adverse cardiac events (MACE). Secondary endpoints include repeatability of FFR and CFR, angina burden, and the percentage of successful FFR/CFR measurements which will not be excluded by the corelab.MethodsThis prospective, non-blinded, non-randomized, and multi-center study enrolled 455 subjects from 12 sites in Europe and Japan. Patients underwent physiologic lesion assessment using the 0.014” Philips Volcano ComboWire XT that provides simultaneous pressure and Doppler velocity sensors. Intermediate coronary lesions received only medical treatment unless both FFR (≤0.8) and CFR ( 0.80 and CFR ≥ 2.0. Enrollment has been completed and final follow-up will occur in November 2019.
       
  • Variations in stepped-wedge cluster randomized trial design: Insights from
           the ‘patient-centered care transitions in heart failure’ trial
    • Abstract: Publication date: Available online 1 September 2019Source: American Heart JournalAuthor(s): Rudy R. Unni, Shun Fu Lee, Lehana Thabane, Stuart Connolly, Harriette GC Van SpallAbstractThe stepped-wedge (SW) cluster randomized controlled trial (RCT), in which clusters cross over in a randomized sequence from control to intervention is ideal for the implementation and testing of complex health service interventions. In certain cases, however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required.We examine the logistical and statistical implications of variations in SW design, using the optimization of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) trial for illustration. We review the following complete SW design variations: a typical SW design; a SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested sub-studies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed three incomplete SW design variations in which data is collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to accommodate cluster readiness.Variations in SW design offer pragmatic solutions to logistical challenges but have implications to statistical power. Advantages and disadvantages of each variation should be considered before finalizing the design of a SW RCT.
       
  • Ticagrelor-based antiplatelet regimens in patients with atherosclerotic
           artery disease - a meta-analysis of randomized clinical trials
    • Abstract: Publication date: Available online 31 August 2019Source: American Heart JournalAuthor(s): Salvatore Cassese, Gjin Ndrepepa, Robert A. Byrne, Karl-Ludwig Laugwitz, Heribert Schunkert, Massimiliano Fusaro, Fernando Alfonso, Adnan KastratiBackgroundRandomized trials did not consistently support superiority of ticagrelor, as monotherapy or in combination with aspirin, in terms of efficacy or safety, in patients with atherosclerotic artery disease.MethodsMedline, EMBASE, the Cochrane Central Register of Controlled Trials and scientific session abstracts were searched for trials of patients with coronary or peripheral artery disease (with>1000 participants and a follow-up ≥3 months) randomly assigned to ticagrelor-based or conventional antiplatelet therapies. Trial-level hazard ratios were pooled using a fixed or random effect model (in case of significant heterogeneity) with the inverse variance weighting. The primary outcome was all-cause mortality. Other outcomes were myocardial infarction (MI), stroke and major bleeding.ResultsOverall 77,489 patients received either ticagrelor-based (n = 38,721) or conventional antiplatelet regimens (n = 38,768) in six trials. The primary outcome occurred in 4.5% of patients treated with experimental therapy and 4.9% of patients treated with control therapy (hazard ratio [HR] = 0.91, 95% confidence interval [CI] 0.81 to 1.01; P = .07). Overall, patients treated with ticagrelor-based versus conventional antiplatelet regimens showed no significant difference in terms of all-cause death, MI, stroke or major bleeding after 20 months. However, in trials of patients with coronary artery disease (CAD) as primary diagnosis, the risk for all-cause death (HR = 0.84 [0.77–0.91], P 
       
 
 
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