Trial Files: Edoxaban for A Fib/Stable CAD, Finerenone for Preserved EF, and Beta-Blockers after MI
Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease (EPIC-CAD)
The EPIC-CAD Investigators. NEJM (September 2024)
Bottom line: This multicenter, open-label, adjudicator-masked, randomized trial compared edoxaban monotherapy with dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) in 1040 patients with atrial fibrillation and stable coronary artery disease (CAD), defined as CAD previously treated with revascularization or managed medically. The primary outcome was a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major bleeding or clinically relevant non-major bleeding at 12 months. The mean age of the patients was 72.1 years, 22.9% were women, and the mean CHA2DS2-VASc score was 4.3. Edoxaban monotherapy was found to be more effective than dual antithrombotic therapy, with 6.8% of patients experiencing a primary-outcome event as compared to 16.2% of patients in the dual antithrombotic therapy group (hazard ratio, 0.44; 95% confidence interval [CI], 0.30 to 0.65; P<0.001). Safety outcomes also favoured edoxaban monotherapy, with a lower incidence of major bleeding or clinically relevant nonmajor bleeding (4.7% vs. 14.2%, hazard ratio, 0.34; 95% CI, 0.22 to 0.53). The cumulative incidence of major ischemic events at 12 months appeared similar in both groups. This study provides evidence for the use of edoxaban monotherapy in patients with atrial fibrillation and stable coronary artery disease.
Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction (FINEARTS-HF)
The FINEARTS-HF Committees & Investigators. NEJM (September 2024)
Bottom Line: This international, double-blind trial evaluated the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in patients with heart failure and mildly reduced or preserved ejection fraction of 40% or greater. A total of 6001 patients were randomly assigned to receive either finerenone (at a maximum dose of 20 mg or 40 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of total worsening heart failure events (defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes over a median follow-up of 32 months. There were 1083 primary outcome events in 624 patients in the finerenone group, compared to 1283 events in 719 patients in the placebo group (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P=0.007). The percentage of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). However, finerenone was associated with an increased risk of hyperkalemia and a reduced risk of hypokalemia. In conclusion, finerenone showed a significant reduction in total worsening heart failure events and death from cardiovascular causes in patients with heart failure and mildly reduced or preserved ejection fraction.
Beta-Blocker Interruption or Continuation after Myocardial Infarction (ACTION)
The ABYSS Investigators of the ACTION Study Group. NEJM (August 2024)
Bottom Line: This multicenter, open label, randomized, noninferiority trial aimed to determine the safety and efficacy of interrupting long-term beta-blocker treatment in patients with a history of uncomplicated myocardial infarction. A total of 3698 patients with left ventricular ejection fraction > 40% on long term beta-blocker treatment, with no cardiovascular event in the previous 6 months, were randomly assigned to either the interruption or continuation group. The primary outcome was a composite of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow up (minimum, 1 year), according to an analysis of noninferiority (defined as a between-group difference of < 3 percentage points for the upper boundary of the two-sided 95% confidence interval). A primary-outcome event occurred in 432 of 1812 patients (23.8%) in the interruption group and in 384 of 1821 patients (21.1%) in the continuation group (risk difference, 2.8 percentage points; 95% confidence interval [CI], <0.1 to 5.5), for a hazard ratio of 1.16 (95% CI, 1.01 to 1.33; P=0.44 for noninferiority). Beta-blocker interruption did not seem to improve the patients’ quality of life as measured by the European Quality of Life-5 Dimensions questionnaire. Overall, interruption of long-term beta-blocker treatment was not found to be noninferior to a strategy of beta-blocker continuation.
Trial Files Issue #2024-22
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