Total Ischemic Event Reduction with Rivaroxaban after Peripheral Arterial Revascularization in the VOYAGER PAD Trial.

ABSTRACT Background Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. VOYAGER PAD 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 To evaluate the total burden of vascular events in PAD patients after LER and the efficacy of low dose rivaroxaban on total events. Methods VOYAGER PAD randomized PAD patients 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 CV 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. Hazard ratios were estimated by marginal proportional hazards models. Results Among 6564 randomized there were 4714 total first and subsequent vascular events including 1614 primary endpoint events and 3100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR 0.86,95% CI 0.75-0.98; p=0.02) and total vascular events (HR 0.86,95% CI 0.79-0.95; p=0.003). An estimated 4.4 primary and 12.5 vascular events/100 participants were avoided with rivaroxaban over three years. Conclusions Symptomatic PAD patients undergoing LER have a high total event burden which is significantly reduced with rivaroxaban. Total event reduction may be useful metric to quantify the efficacy of rivaroxaban in this setting.