Cardio Trial Files Throwback Thursday: Apixaban vs. Warfarin in AF, Oral Iron vs. Placebo in HFrEF and Iron Deficiency, and Fondaparinux vs. Enoxaparin in NSTE-ACS
Apixaban versus Warfarin in Patients with Atrial Fibrillation
Granger CB et al. NEJM (September 2011)
Bottom Line: This randomized, double-blind trial compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke over a median follow-up of 1.8 years. Primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The primary objective was to test for noninferiority, a secondary objective was to test for superiority, Apixaban was found to be noninferior and superior to warfarin in preventing the primary outcome. Apixaban was found to be both noninferior and superior to warfarin in preventing the primary outcome (HR, 0.79; 95% CI, 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rates of major bleeding and mortality was lower in the apixaban group as well.
Effect of Oral Iron Repletion on Exercise Capacity in Patients With Heart Failure With Reduced Ejection Fraction and Iron Deficiency (IRONOUT)
Lewis GD et al. JAMA (May 2017)
Bottom Line: This phase 2, double-blind, placebo-controlled randomized clinical trial enrolled 225 patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and iron deficiency to test if therapy with oral iron polysaccharide improves peak exercise capacity. The primary outcome, change in peak oxygen uptake from baseline to 16 weeks (+23 mL/min vs −2 mL/min; difference, 21 mL/min; 95% CI, −34 to +76 mL/min; P = 0.46), did not significantly differ between the oral iron and placebo groups. Secondary outcomes, including change in 6-minute walk distance, plasma N-terminal pro-B-type natriuretic peptide levels, and health status as assessed by Kansas City Cardiomyopathy Questionnaire, also did not significantly differ between treatment groups. These results do not support use of oral iron supplementation in patients with HFrEF.
Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes
OASIS-5 Investigators. NEJM (April 2006)
Bottom Line: This randomized controlled, noninferiority, trial included 20,078 patients with acute coronary syndromes who were followed for up to six months. Patients were assigned to receive either fondaparinux (2.5 mg daily) or enoxaparin (1 mg per kilogram of body weight twice daily) for a mean of six days. The primary outcome was death, myocardial infarction, or refractory ischemia at nine days. Results showed that the number of patients with primary-outcome events was similar in the two groups (579 with fondaparinux (5.8%) vs 573 with enoxaparin (5.7%) (HR, 1.01; 95 CI, 0.90 to 1.13), satisfying the noninferiority criteria Major bleeding at nine days was markedly lower with fondaparinux than with enoxaparin, and the composite of the primary outcome and major bleeding at nine days favored fondaparinux. Fondaparinux was associated with a significantly reduced number of deaths at 30 days and at 180 days. The conclusion was that fondaparinux is similar to enoxaparin in reducing the risk of ischemic events at nine days, but it substantially reduces major bleeding and improves long term mortality and morbidity.
Cardio Trial Files Issue #CRD-2024-13
Want to view past issues? Visit our archive: