Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial

作者：Rupert Bauersachs, Michael Szarek, Marianne Brodmann, Ivan Gudz, E. Sebastian Debus, Mark R. Nehler, Sonia S. Anand, Manesh R. Patel, Connie N. Hess, Warren H. Capell, Kevin Rogers, Eva Muehlhofer, Lloyd Haskell, Scott D. Berkowitz, William R. Hiatt, Marc P. Bonaca · 发表于：Journal of the American College of Cardiology · 年份：2021 · DOI：10.1016/j.jacc.2021.05.003 · 被引用次数：55 · 研究领域：Peripheral Artery Disease Management、Diagnosis and Treatment of Venous Diseases、Antiplatelet Therapy and Cardiovascular Diseases

BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. 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) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown. OBJECTIVES: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events. METHODS: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models. RESULTS: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascula...