Low-Dose Rivaroxaban Plus Aspirin in Fragile Patients After Lower Extremity Revascularization

作者：Mario Enrico Canonico, Cecilia C. Low Wang, Judith Hsia, E. Sebastian Debus, Mark R. Nehler, Manesh R. Patel, Sonia S. Anand, J. Ycas, Warren H. Capell, Eva Muehlhofer, Lloyd Haskell, Scott D. Berkowitz, Rupert Bauersachs, Marc P. Bonaca · 发表于：Journal of the American College of Cardiology · 年份：2024 · DOI：10.1016/j.jacc.2024.05.060 · 被引用次数：11 · 研究领域：Peripheral Artery Disease Management、Heart Failure Treatment and Management、Cardiac, Anesthesia and Surgical Outcomes

BACKGROUND: Rivaroxaban 2.5 mg plus aspirin reduced limb and cardiovascular events and increased bleeding in patients with symptomatic peripheral artery disease (PAD) after lower extremity revascularization in the VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) study. Fragile patients are at heightened risk for ischemic and bleeding events. OBJECTIVES: The purpose of this study was to investigate the safety and efficacy of rivaroxaban 2.5 mg in fragile patients from VOYAGER PAD. METHODS: ). The primary efficacy outcome was the composite of acute limb ischemia, major amputation of a vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was TIMI major bleeding. RESULTS: Of 6,564 randomized patients, a total of 1,674 subjects were categorized as fragile at baseline. In the placebo arm, fragile patients were at higher risk of the primary outcome (HR: 1.34; 95% CI: 1.12-1.61) and TIMI major bleeding (HR: 1.57; 95% CI: 0.83-2.96), compared with nonfragile patients. The effect of rivaroxaban on the primary endpoint was not modified by frailty status (fragile HR: 0.93; 95% CI: 0.75-1.15; nonfragile HR: 0.83; 95% CI: 0.72-0.97; P interaction = 0.37). Rivaroxaban increased TIMI major bleeding in fragile (HR: 1.54; 95% CI: 0.82-2.91) and nonfr...