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- Adherence and Discontinuation of Disease-Specific Therapies for Pulmonary
Arterial Hypertension: A Systematic Review and Meta-Analysis-
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Abstract: Background In patients with pulmonary arterial hypertension (PAH), the use of disease-specific therapies (i.e., endothelin receptor antagonists, phosphodiesterase type-5 inhibitors, soluble guanylate cyclase stimulators, prostacyclins, and prostanoids) has been associated with disease improvement and decreased mortality risk. We aimed to quantify the adherence and discontinuation rates for patients prescribed PAH-specific therapies. Methods We performed a systematic review via searching MEDLINE, EMBASE, and the Cochrane Library from their inception to 4 March 2022 for observational studies published in English that reported data on adherence to and persistence with PAH-targeted therapies. Random-effects meta-analysis was performed to explore average adherence and discontinuation rates. Results In all, 14 studies involving 14,861 individuals prescribed PAH-targeted therapies were included. The overall pooled proportion of patients adherent to their PAH-targeted medications was 60.9% (95% confidence interval [CI] 52.3–69.1%). The pooled proportions of patients adherent in questionnaire-based studies and in studies using prescription/dispensing data were 52.9% (95% CI 48.9–56.9%) and 62.9% (95% CI 53.1–72.2%), respectively. The pooled proportion of patients who discontinued their PAH-targeted medications was 42.3% (95% CI 31.6–53.3). Factors reported to impact adherence included administration frequency, length of time on treatment, co-payment, and occurrence of adverse events. Conclusions In the real world, a considerable proportion of patients prescribed PAH-specific therapies were non-adherent or discontinued. As diverse factors may influence treatment adherence, multifaceted interventions are needed to address this trend in order to improve patient outcomes. Registration The systematic review protocol was registered in the PROSPERO database (CRD42022316638).
PubDate: 2022-11-25
- Statins Reduce Bleeding Risk in Patients Taking Oral Anticoagulants for
Nonvalvular Atrial Fibrillation: A Retrospective Registry Study-
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Abstract: Background The effects of statins in patients with non-valvular atrial fibrillation (NVAF) taking oral anticoagulants (OACs) are not well-studied. This study was a historical multicenter registry of patients with NVAF taking OACs in Japan. Methods We excluded those patients with mechanical heart valves or a history of pulmonary or deep vein thrombosis. Overall, 7826 patients were registered on 26 February 2013 and followed until 25 February 2017. We compared those with versus without statin treatment (statin vs. no-statin groups) for the primary outcome of major bleeding and secondary outcomes of all-cause mortality, ischemic events, hemorrhagic stroke, and ischemic stroke. Results Statins were administered in 2599 (33%) patients. The statin group was more likely to have paroxysmal AF (37% vs. 33%; p = 0.0003), hypertension (84% vs. 76%; p < 0.0001), diabetes mellitus (41% vs. 27%; p < 0.0001), and dyslipidemia (91% vs. 30%; p < 0.0001) than the no-statin group. The cumulative incidence of major bleeding was 6.9% and 8.1% (p = 0.06). The adjusted hazard ratio [HR] (95% confidence interval [CI]) of the statin group for major bleeding was 0.77 (0.63–0.94) compared with the no-statin group. The adjusted HR (95% CI) for all-cause mortality, ischemic events, hemorrhagic stroke, and ischemic stroke were 0.58 (0.47–0.71), 0.77 (0.59–0.999), 0.85 (0.48–1.50), and 0.79 (0.60–1.05), respectively. Conclusions Statins significantly reduced the risk of major bleeding, all-cause mortality, and ischemic events in patients with NVAF taking OACs. Their additive benefits should be considered in routine practice and thus be further researched.
PubDate: 2022-11-16
- Apixaban Use in Obese Patients: A Review of the Pharmacokinetic,
Interventional, and Observational Study Data-
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Abstract: Relatively little is known about the influence of extreme body weight on the pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of drugs used in many disease states. While direct oral anticoagulants (DOACs) have an advantage over warfarin in that they do not require routine drug monitoring, some may regard this convenience as less compelling in obese patients. Some consensus guidelines discourage using DOACs in patients weighing > 120 kg or with a body mass index > 35–40 kg/m2, given a sparsity of available data in this population and the concern that fixed dosing in obese patients might lead to decreased drug exposure and lower efficacy. Per the prescribing information, apixaban does not require dose adjustment in patients weighing above a certain threshold (e.g., ≥ 120 kg). Data from healthy volunteers and patients with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) have shown that increased body weight has a modest effect on apixaban’s PK. However, the paucity of exposure data in individuals > 120 kg and the lack of guideline consensus on DOAC use in obese patients continue to raise concerns about potential decreased drug exposure at extreme weight. This article is the first to comprehensively review the available PK data in obese individuals without NVAF or VTE, and PK, PD, efficacy, effectiveness, and safety data for apixaban in obese patients with either NVAF or VTE, including subgroup analyses across randomized controlled trials and observational (real-world) studies. These data suggest that obesity does not substantially influence the efficacy, effectiveness, or safety of apixaban in these patients. Trial Registration ARISTOTLE: NCT00412984; AVERROES: NCT00496769; AMPLIFY: NCT00643201; AMPLIFY-EXT: NCT00633893; ADVANCE-1: NCT00371683; ADVANCE-2: NCT00452530; ADVANCE-3: NCT00423319 Video abstract Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data (MP4 161.22 MB)
PubDate: 2022-11-01
- Abbreviated versus Standard Duration of DAPT after PCI: A Systematic
Review and Network Meta-analysis-
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Abstract: Background Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) is typically continued for 6–12 months depending on clinical presentation. Recent studies have evaluated the safety of shorter durations of DAPT across stable and unstable coronary syndrome but are limited by smaller patient pools and varying indications. Methods The present study performed a systematic review and network meta-analysis comparing abbreviated (1–3 months) with standard (6–12 months) duration of DAPT. Both conventional and frequentist network meta-analyses with a random-effects model were conducted. Results Seventeen randomized controlled trials, nine of which included 1–3 months of DAPT, were selected. The risks of any bleeding (RR 0.68, 95% CI 0.54–0.85), major bleeding (RR 0.66, 95% CI 0.50–0.86), and net adverse clinical events (NACE) (RR 0.87, 95% CI 0.76–0.99) were lower with abbreviated (1–3 months) than standard-term (6–12 months) DAPT. No significant differences in the risk of myocardial infarction (RR 1.02, 95% CI 0.87–1.18), definite or probable stent thrombosis (RR 1.11, 95% CI 0.83–1.50), and major adverse cardiac events (MACE) (RR 0.96, 95% CI 0.86–1.06) were observed. Network meta-analysis demonstrated lower risk of any bleeding, major bleeding, and NACE with shorter durations of DAPT compared with 12 months. Risks of definite or probable stent thrombosis, myocardial infarction, and MACE were not significantly different. Conclusion The results support the growing body of evidence that abbreviated duration (1–3 months) of DAPT may be considered to reduce the risk of bleeding without any differences in myocardial infarction, stent thrombosis, or MACE.
PubDate: 2022-11-01
- Benefits and Risks Associated with Low-Dose Aspirin Use for the Primary
Prevention of Cardiovascular Disease: A Systematic Review and
Meta-Analysis of Randomized Control Trials and Trial Sequential Analysis-
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Abstract: Background The role of aspirin in cardiovascular primary prevention remains controversial. Moreover, evidence for the potential benefits of aspirin in patients with high cardiovascular risk remains limited. Objective The aim of this study was to explore the role of low-dose aspirin in primary prevention. Methods The PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov databases were searched for randomized clinical trials (RCTs) from the date of inception to August 2021. The efficacy outcomes were major adverse cardiovascular events (MACE), myocardial infarction (MI), ischemic stroke (IS), all-cause mortality, and cardiovascular mortality, whereas safety outcomes were major bleeding, intracranial hemorrhage, and gastrointestinal (GI) bleeding. Subgroup analyses were based on different cardiovascular risks and diabetes statuses. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using the fixed- and random-effects models, and trial sequential analysis (TSA) was conducted to determine the robustness of the results. Results A total of 10 RCTs fulfilled the inclusion criteria. The use of aspirin was associated with a significant reduction in the risk of MACE (RR 0.89, 95% CI 0.84–0.93), MI (RR 0.86, 95% CI 0.78–0.95), and IS (RR 0.84, 95% CI 0.76–0.93); however, aspirin also increased the risk of safety outcomes, i.e. major bleeding (RR 1.42, 95% CI 1.26–1.60), intracranial hemorrhage (RR 1.33, 95% CI 1.11–1.59), and GI bleeding (RR 1.91, 95% CI 1.44–2.54). Subgroup analyses revealed that in the absence of a statistically significant interaction, a trend toward a net benefit of lower incidence of cardiovascular events (number needed to treat of MACE: high risk: 682 vs. low risk: 2191) and lesser risk of bleeding events (number needed to harm of major bleeding: high risk: 983 vs. low risk: 819) was seen in the subgroup of high cardiovascular risk. Meanwhile, the greater MACE reduction was also detected in the high-risk group of diabetes or nondiabetes patients. Furthermore, a post hoc subgroup analysis indicated a significant rate reduction in patients aged ≤ 70 years but not in patients aged > 70 years. TSA confirmed the benefit of aspirin for MACE up to a relative risk reduction of 10%. Conclusion The current study demonstrated that the cardiovascular benefits of low-dose aspirin were equally balanced by major bleeding events. In addition, the potential beneficial effects might be seen in the population ≤ 70 years of age with high cardiovascular risk and no increased risk of bleeding.
PubDate: 2022-11-01
- Potential Cardiovascular Events Avoided with Bempedoic Acid Plus Ezetimibe
Fixed-Dose Combination Compared with Ezetimibe Alone in Patients with
-
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Abstract: Background Patients with atherosclerotic cardiovascular disease who require additional low-density lipoprotein cholesterol (LDL-C) lowering despite maximally tolerated statins have a significant unmet medical need and are at increased risk of future cardiovascular events and a reduced quality of life. Objective We aimed to estimate the percentage of cardiovascular events avoided following treatment with a fixed-dose combination of bempedoic acid plus ezetimibe (BA+EZE FDC) versus ezetimibe (EZE) in patients with atherosclerotic cardiovascular disease receiving maximally tolerated statins across a range of baseline LDL-C levels. Methods A Markov cohort simulation model estimated major adverse cardiovascular events avoided over a lifetime horizon among patients with atherosclerotic cardiovascular disease and baseline LDL-C levels from 80 to >200 mg/dL. BA+EZE FDC was compared with EZE based on mean percent LDL-C reductions versus placebo reported in a phase III trial. Health outcomes for the average patient were extrapolated to a US population of 100,000 persons using evidence on contemporary LDL-C levels from the National Health and Nutrition Examination Survey. Results Among patients with atherosclerotic cardiovascular disease not at the LDL-C goal with maximally tolerated statins, the addition of BA+EZE FDC compared with the addition of EZE was predicted to provide incremental absolute reductions in major adverse cardiovascular events dependent on baseline LDL-C levels at the population level. For those with baseline LDL-C of 101–110 mg/dL (n = 15,237), there were 4.9% (744) fewer events predicted, while for patients with baseline LDL-C of > 200 mg/dL (n = 1689), 10.9% (184) fewer events were predicted through the addition of BA+EZE FDC versus EZE. Conclusions Further LDL-C reductions through the addition of BA+EZE FDC to maximally tolerated statins are predicted to reduce major adverse cardiovascular events compared with the addition of EZE. Benefits are potentially greater among those with higher starting LDL-C.
PubDate: 2022-10-31
- A Real-World Matched Cohort Study of the Effect of Concomitant Amiodarone
or Diltiazem Administration on Apixaban Peak and Trough Concentrations-
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Abstract: Background Apixaban is a substrate for p-glycoprotein and is extensively metabolized by cytochrome P450 (CYP) 3A4. There are minimal published data regarding the effect of amiodarone and diltiazem on apixaban serum concentrations. Objective The aim of this study was to determine the degree of elevation of apixaban concentrations resulting from amiodarone or diltiazem. Methods This was a matched cohort study approved by the Institutional Review Board. Patients receiving apixaban 5 mg twice daily with concomitant diltiazem or amiodarone were enrolled. Control groups were enrolled via matching characteristics of sex, age, weight, creatinine clearance, and statin therapy. Exclusions were an inappropriate dosage of apixaban or concomitant dronedarone, verapamil, ranolazine, naproxen, or both amiodarone and diltiazem. Blood samples were collected 3–4 h after and 0.5–2 h before an apixaban dose, corresponding to peak and trough concentrations, respectively. Results were compared using a t test. Results Thirty patients were enrolled in each of the four groups. The mean peak apixaban concentration was 239 ± 82 ng/mL in the amiodarone group and 208 ± 66 ng/mL in the corresponding control group (p = 0.068). Trough concentrations were 142 ± 71 ng/mL and 117 ± 41 ng/mL, respectively (p = 0.055). The mean peak apixaban concentration was 243 ± 99 ng/mL in the diltiazem group and 213 ± 82 ng/mL in the control group (p = 0.11). Trough concentrations were 130 ± 65 ng/mL and 108 ± 54 ng/mL, respectively (p = 0.09). Conclusion Coadministration of amiodarone and diltiazem resulted in a trend toward increased apixaban concentrations. The extent of elevation suggests that empiric dose changes are not necessary; however, individual patients may benefit from monitoring and dose adjustment.
PubDate: 2022-10-31
- Antithrombotic Strategy in Secondary Prevention for High-Risk Patients
with Previous Acute Coronary Syndrome: Overlap between the PEGASUS
Eligibility and the COMPASS Eligibility in a Large Multicenter Registry-
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Abstract: Background Patients with previous acute coronary syndrome (ACS) are at high risk of recurrent adverse cardiovascular events. Recently, prolonged dual antiplatelet therapy (DAPT) and oral anticoagulation therapy (OAT) have been shown to reduce recurrent ischemic events to the expense of an increase in bleeding events. The number of patients potentially eligible for these therapies in real life remains to be determined. Methods Among ACS patients from five registries and one randomized controlled trial, we assessed the proportion of patients eligible for the PEGASUS strategy only and the proportion of patients eligible for the COMPASS strategy only, and set out the proportion of patients with an overlap between the strategies. Findings Among the 10,048 evaluable patients, we found that 5373 (53.4%) were eligible for the PEGASUS strategy and 3841 (38.2%) were eligible for the COMPASS strategy, with a group of 3444 (34.4%) overlapping between the two strategies. The number of patients eligible for the PEGASUS strategy only was 1929 (19.2%) and the number eligible for the COMPASS strategy only was 397 (4.0%); 4278 (42.6%) were eligible for neither a PEGASUS strategy nor a COMPASS strategy. Interpretation In a large cohort of ACS patients, one in three patients was eligible for either a prolonged DAPT with ticagrelor 60 mg and low-dose aspirin or a dual pathway inhibition approach with rivaroxaban 2.5 mg and low-dose aspirin.
PubDate: 2022-10-31
- Acknowledgement to Referees
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PubDate: 2022-10-23
- Novel Pulmonary Delivery of Drugs for the Management of Atrial
Fibrillation-
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Abstract: Abstract Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, affecting approximately 335 million patients worldwide. Comprehensive pharmacological treatment of AF includes medications for rate or rhythm control and anticoagulants to reduce the risk of thromboembolism; yet, these agents have significant limitations. Oral anti-arrhythmic agents have a slow onset of action, and rapid onset formulations require hospitalization for intravenous therapy. Orally administered drugs also require high doses to attain therapeutic levels, and thus dose-related severe adverse effects are often unavoidable. Given the therapeutic benefits of inhaled drug delivery, including rapid onset of action and very low doses to achieve therapeutic efficacy, this review will discuss the benefits of novel pulmonary delivery of drugs for the management of AF.
PubDate: 2022-10-18
- Cost-Effectiveness of Adding Empagliflozin to Standard Treatment for Heart
Failure with Preserved Ejection Fraction Patients in China-
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Abstract: Objectives Heart failure is a worldwide health problem and is the leading cause of hospitalization in older patients. Heart failure with preserved ejection fraction (HFpEF) accounts for about 38% of heart failure cases. The latest EMPEROR-Preserved study shows that empagliflozin can reduce the risk of hospitalization in HFpEF, but whether empagliflozin is cost-effective in HFpEF in a Chinese setting remained uninvestigated. Methods A simulation of lifetime horizon for a 72-year-old HFpEF patient was conducted using a Markov model. The primary outcome was incremental cost-effectiveness ratio (ICER), expressed as incremental costs per quality-adjusted life-year (QALY). Three times the per capita GDP of China was set as the willingness-to-pay (WTP) threshold. Empagliflozin was considered cost-effective if the ICER was below the WTP threshold, otherwise it would be regarded as not cost-effective. One-way sensitivity and probabilistic sensitivity analysis (PSA) were used to assess uncertainty. Results After a simulation of lifetime horizon, a 72-year-old HFpEF patient is expected to have an expected QALY of 4.80 in the empagliflozin group, and 4.67 QALY with standard treatment. The costs of empagliflozin and standard treatment are 34,987 (US$5423) and 27,027 (US$4189) Chinese Yuan (CNY), respectively, with an ICER of 63,746 (US$9881)/QALY, lower than the WTP threshold. One-way sensitivity and PSA show that our results are robust. Conclusion In Chinese HFpEF patients, adding empagliflozin to standard treatment is cost-effective, but studies based on real-world data are needed.
PubDate: 2022-10-08
- Haemodynamic Effects of Sacubitril/Valsartan Initiation in Outpatients
with Chronic Heart Failure-
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Abstract: Background Sacubitril/valsartan (S/V) improves outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Data about the immediate, short-, and intermediate-term hemodynamic effects of S/V are limited. Methods In this prospective observational study, 37 outpatients with chronic HFrEF were treated with S/V according to current guideline recommendations. Next to clinical, laboratory and echocardiographic parameters, haemodynamic variables were assessed non-invasively by use of inert gas rebreathing and bioimpedance cardiography at baseline and at 2-week, 3-month and 6-month follow-up. The course of variables throughout the study and the relationship between variables were analysed using fractional polynomials. Results S/V treatment resulted in short- and intermediate-term improvements in NYHA functional class (2.3 ± 0.6 at baseline vs. 1.9 ± 0.5 at 6-month follow-up, p = 0.14), 6-min walk test (453 ± 110 vs. 528 ± 98 m, p = 0.02), ejection fraction (31 ± 9 vs. 36 ± 12%, p = 0.13), pulmonary artery pressure (39 ± 10 vs. 31 ± 10 mmHg, p = 0.02), and NT-proBNP values (1702 (782–2897 vs. 1004 (599–1627) ng/L, p = 0.03). In addition, S/V caused immediate decreases in systemic vascular resistance index (SVRI) and systolic blood pressure (SBP), which were associated with a simultaneous drop in stroke volume (SV) and cardiac index (CI). However, while SVRI and SBP remained at low levels during further treatment, SV and CI restored rapidly and increased to slightly higher levels thereafter. Conclusion The vasodilative effects of S/V result in immediate reductions in SVRI, SBP, SV and CI. However, S/V induces reverse cardiac remodelling, which is apparent shortly after treatment initiation and leads to improvements of clinical, functional, echocardiographic, laboratory and haemodynamic variables.
PubDate: 2022-09-22
DOI: 10.1007/s40256-022-00549-2
- Atrial Fibrillation Management: A Comprehensive Review with a Focus on
Pharmacotherapy, Rate, and Rhythm Control Strategies-
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Abstract: Abstract Atrial fibrillation (AF) is an increasingly common arrhythmia encountered in clinical practice that leads to a substantial increase in utilization of healthcare services and a decrease in the quality of life of patients. The prevalence of AF will continue to increase as the population ages and develops cardiac comorbidities; thus, prompt and effective treatment is important to help mitigate systemic resource utilization. Treatment of AF involves two tenets: prevention of stroke and systemic embolism and symptom control with either a rate or a rhythm control strategy. Historically, due to the safe nature of medications like beta-blockers and non-dihydropyridine calcium channel blockers, used in rate control, it has been the initial strategy used for symptom control in AF. Newer data suggest that a rhythm control strategy with antiarrhythmic medications with or without catheter ablation may lead to a reduction in major adverse cardiovascular events, particularly in patients newly diagnosed with AF. Modulation of factors that promote AF or its complications is another important aspect of the overall holistic management of AF. This review provides a comprehensive focus on the management of patients with AF and an in-depth review of pharmacotherapy of AF in the rate and rhythm control strategies.
PubDate: 2022-09-01
DOI: 10.1007/s40256-022-00529-6
- Effectiveness and Safety of Thyroid Hormone Therapy in Patients with
Dilated Cardiomyopathy: A Systematic Review and Meta-analysis of RCTs-
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Abstract: Background Previous research demonstrated that short-term treatment of dilated cardiomyopathy with thyroid hormones exerted beneficial hemodynamic effects when added to standard anti-heart failure therapy, but it remains debatable whether thyroid hormones can be used to treat dilated cardiomyopathy. Therefore, we conducted a meta-analysis to evaluate the effectiveness and safety of thyroid hormone treatment in patients with dilated cardiomyopathy. Methods The Cochrane Clinical Trials Registry database, PubMed, Embase, Chinese Biomedical Literature Database, China Academic Journals full-text database, Wanfang Database, China Science and Technology Journal Database, and Clinical Trials.gov were screened through 15 October, 2021. Randomized controlled clinical trials were selected based on study inclusion criteria. Two independent reviewers extracted the data and assessed study bias using the Cochrane risk of bias tool. For the data synthesis, the weighted mean difference was calculated using baseline and post-thyroid hormone treatment data. Random-effects models were used for the meta-analysis. The primary outcomes were left ventricular ejection fraction after a minimum follow-up of 1 week and adverse events. Results Ten of the 1149 published reports met the inclusion criteria (N = 608 randomized individuals). After reasonable use of thyroid hormone therapy, left ventricular ejection fraction increased (weighted mean difference, 3.94; 95% confidence interval 3.06–4.81; I2 = 0.00%), cardiac output increased, and left ventricular end-diastolic diameter decreased, but left ventricular mass index and thyroid function were unaffected. Adverse events were reported in the intervention group of two studies. The ten studies demonstrated a low risk of bias. Conclusions Adding thyroid hormones to conventional anti-heart failure treatment in patients with DCM appears to be an effective and well tolerated therapeutic option. Clinical Trial Registration The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42021286043).
PubDate: 2022-09-01
DOI: 10.1007/s40256-022-00548-3
- Remdesivir-induced Bradycardia is not Associated with Worse Outcome in
Patients with COVID-19: A Retrospective Analysis-
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Abstract: Background COVID-19, is primarily a respiratory illness but is known to cause extrapulmonary manifestations, especially on the cardiovascular system. Bradycardia is commonly reported in COVID-19 patients despite no prior history of occurrence, and many studies have shown an association with increased mortality. Multiple case reports have been published showcasing remdesivir potentially causing bradycardia. Our aim was to investigate the incidence of bradycardia in patients receiving remdesivir and examine the association with disease severity and survival outcomes. Methods A retrospective study was performed including 160 COVID-19 patients receiving remdesivir for 5 days. Patients’ demographics, comorbidities, medication, vital signs, laboratory tests and outcome were recorded. Bradycardia was defined as a heart rate < 60 beats/min and severe bradycardia < 50 beats/min. Results One hundred eighteen (73.8%) patients experienced at least one episode of bradycardia during hospitalisation. Bradycardia was present in 12 (7.5%) patients before treatment with remdesivir. The rate of bradycardia increased up to the 6th day of hospitalisation (40.6%) and subsequently diminished and normalised within 5 days after the last remdesivir dose (5% at Day 10). Severe bradycardia was observed in 13 (7.5%) patients. No difference was observed in ICU admission between groups (bradycardia vs no bradycardia). When we stratified patients according to the outcome of hospitalisation, no significant difference was observed in the occurrence of bradycardia between groups (alive vs dead) [p = 0.853]. Conclusions Treatment with remdesivir may be associated with new-onset bradycardia in hospitalised patients with COVID-19. However, bradycardia is transient and is not associated with ICU admission and mortality.
PubDate: 2022-08-25
DOI: 10.1007/s40256-022-00547-4
- Early Statin Therapy and In-Hospital Outcomes in Acute Coronary Syndrome
Patients Presenting with Advanced Killip Class at Admission: Findings from
the CCC-ACS Project-
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Abstract: Purpose It is unknown if acute coronary syndrome (ACS) patients presenting with advanced Killip class (III/IV) would benefit from early statin therapy. Therefore, we aimed to explore the relationship between statin therapy within the first 24 h of medical contact and in-hospital outcomes in this patient population in a nationwide registry. Method In the Improving Care for Cardiovascular Disease in China—ACS project, among ACS patients presenting with Killip class III/IV, we performed the following three analyses: (i) the associations between early statin therapy and risks for in-hospital mortality and ischaemic events; (ii) the dose effect of statins on mortality and (iii) the interaction between low-density lipoprotein cholesterol (LDL-C) levels and statins on mortality. Result Among 104,516 ACS patients, 12,149 presented with advanced Killip class and 89.3% received early statins. Multivariable-adjusted logistic regression models revealed a 69% reduction in mortality in the statin group (adjusted odds ratio [OR] 0.31; 95% confidence interval [CI] 0.25–0.39), parallel with a reduction in ischaemic events (adjusted OR 0.50, 95% CI 0.33–0.74), compared with those not receiving early statins, which was consistent in multiple sensitivity analyses. Additionally, the protective association of early statins on in-hospital mortality was observed even among patients that received a low-to-moderate dose. Finally, the short-term survival benefit of early statins was independent of LDL-C. Conclusion In a nationwide ACS registry, statin therapy initiated within the first 24 h of medical contact was associated with a reduced risk of in-hospital mortality in ACS patients presenting with advanced Killip class.
PubDate: 2022-08-13
DOI: 10.1007/s40256-022-00546-5
- SGLT2 Inhibitors: New Hope for the Treatment of Acute Myocardial
Infarction'-
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Abstract: Abstract Among all of the new antidiabetic drugs, an increasing number of studies have evaluated the relationship between the sodium-glucose cotransporter 2 inhibitors (SGLT2i) and acute myocardial infarction (AMI). Since SGLT2i like empagliflozin, canagliflozin, and recently, dapagliflozin have shown impressive positive effects in patients with chronic heart failure with reduced ejection fraction (HFrEF), it has increased research interest to explore the cardiac molecular mechanisms underlying the clinical benefits and attracted more attention to the effects of SGLT2i on a series of cardiovascular events. Experimental and clinical data on SGLT2i treatment after AMI is limited. This is a review of the clinical and preclinical effects of SGLT2i, focusing on available data on the effects of SGLT2i in AMI patients with a brief overview of ongoing trials.
PubDate: 2022-08-10
DOI: 10.1007/s40256-022-00545-6
- Aspirin with Low-Dose Ticagrelor or with Low-Dose Rivaroxaban for
Secondary Prevention: A Cost per Outcome Analysis-
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Abstract: Introduction Secondary prevention of cardiovascular events among patients with diagnosed cardiovascular disease and high ischemic risk poses a significant challenge in clinical practice. The combinations of aspirin with low-dose (LD) ticagrelor or LD rivaroxaban have shown superiority in preventing major adverse cardiovascular events (MACE) compared with aspirin treatment alone. The comparative value for money of these two regimens remains unexplored. Methods We analyzed each regimen's annual cost needed to treat (CNT) by multiplying the annualized number needed to treat (aNNT) by the annual cost of each drug. The aNNTs were based on outcome data from PEGASUS TIMI-54 and COMPASS trials. Scenario analyses were performed to overcome variances in terms of population risk. Costs were calculated as 75% of US National Average Drug Acquisition Cost (NADAC), extracted in January 2022. The primary outcome was defined as CNT to prevent one MACE across the two regimens. Secondary value analysis was performed for myocardial infarction (MI), stroke, and cardiovascular death as separate outcomes. Results The aNNTs to prevent MACE with LD ticagrelor and with LD rivaroxaban were 229 [95% confidence interval (CI) 141–734] and 147 (95% CI 104–252), respectively. At an annual cost of US$3726 versus US$4533, the corresponding CNTs were US$853,254 (95% CI 525,366–2,734,884) with LD ticagrelor and US$666,351 (95% CI 471,432–1,142,316) with LD rivaroxaban. Conclusion Combining aspirin with LD rivaroxaban provides better value for money than with LD ticagrelor for secondary prevention of MACE.
PubDate: 2022-07-23
DOI: 10.1007/s40256-022-00543-8
- Do Oral Factor Xa Inhibitors have a Role in Patients with Mechanical Heart
Valves'-
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Abstract: Abstract Mechanical heart valves (MHVs) replacement is recommended for younger patients with valvular heart disease because of the durability of the mechanical valve, but these patients need antithrombotic therapy for a lifelong time. The vitamin K antagonist (VKA) warfarin is the only approved oral antithrombotic drug for patients with MHVs. The direct oral anticoagulants (DOACs), including direct thrombin inhibitors and factor Xa (FXa) inhibitors, present some advantages over warfarin, such as weak interaction with drugs, no need for routine monitoring of coagulation function, and no frequent adjustment of medication dose. DOACs have been approved in the antithrombotic treatment of venous thromboembolism and nonvalvular atrial fibrillation. However, the application of thrombin inhibitors in patients with MHV is contraindicated because of the RE-ALIGN trial results, and FXa inhibitors are not recommended. Considering the mechanism underlying coagulation, it may be more efficient to inhibit the upstream coagulation FXa than thrombin. Recently, several preclinical and clinical investigations have looked into the role of FXa inhibitors in patients with MHVs, and have provided some encouraging evidence. Herein, we review the completed and ongoing clinical trials, and express our opinion that the following patients with a low risk of thromboembolic events should be considered for treatment with FXa inhibitors: patients with MHVs replacement 3 months postoperatively, patients with isolated aortic valve replacement, patients with a new, low thrombogenicity mechanical valve, and Asian patients. We hope this summary will provide meaningful insights for further clinical investigations.
PubDate: 2022-07-23
DOI: 10.1007/s40256-022-00544-7
- Contemporary Trends in the Use of and Expenditures on Digoxin in the
United States-
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Abstract: Background Digoxin is indicated for the management of heart failure with reduced ejection fraction and atrial fibrillation. Despite stronger guideline recommendations for other pharmacologic and device therapies, digoxin retains a role in select patients unable to tolerate or refractory to standard therapies. Contemporary utilization of and costs related to digoxin in the United States of America (USA) remain uncharacterized. The objective of this study was to estimate trends in digoxin use and expenditures across the USA from 2010 to 2017. Methods We utilized the Medical Expenditure Panel Survey to estimate trends in digoxin use and expenditures across the USA from 2010 to 2017. The Medical Expenditure Panel Survey is an overlapping panel survey that interviews households in the USA to ascertain their healthcare utilization and expenditures. Complex sampling procedures allow for nationally representative estimates of utilization and expenditures. We report the number of digoxin users and expenditures across key subgroups in 2-year increments from 2010 to 2017. Results The number of digoxin users in the USA declined by 47% from 766 users per 100,000 adults in 2010–11 to 402 users per 100,000 adults in 2016–17. While digoxin use declined among women and self-identified White adults, adults living at or below the federal poverty level and those who self-identified as Asian or Hispanic represent an increasing proportion of overall digoxin users. While nationwide digoxin expenditures declined by 26% from 2010–11 to 2012–13, they peaked at $260.3 million in 2014–15 and remained elevated at $188.7 million in 2016–17. Conclusions Despite a nationwide trend towards declining use, digoxin remains prevalent amongst people of Asian and Hispanic descent in the USA. After a spike in cost in 2013, digoxin prices have yet to return to pre-spike levels. The role of digoxin in contemporary heart failure and arrhythmia management will continue to evolve as additional randomized and observational analyses become available.
PubDate: 2022-06-24
DOI: 10.1007/s40256-022-00540-x
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