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

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 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 are unknown. The Objectives: of this study sought to evaluate the total burden of vascular events in patients with PAD after Lower extremity revascularization and the efficacy of low-dose rivaroxaban on total events. Methods:  In this study patients with PAD undergoing Lower extremity revascularization were randomized to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to the 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. As Results: Rivaroxaban significantly reduced total primary endpoint events and total vascular events by (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) & (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003) respectively. An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years. Conclusions: Patients with PAD undergoing Lower extremity revascularization are at high risk of adverse limb and cardiovascular events, with a particularly high burden when considering total events in spite of standard available medical therapy. The risk profile in patients with symptomatic PAD is dominantly driven by adverse limb outcomes, particularly after Lower extremity revascularization, including acute limb ischemia, major vascular amputation, and recurrent revascularization. Rivaroxaban 2.5 mg twice daily with aspirin versus aspirin alone reduces first and subsequent adverse limb and cardiovascular events with an even greater total benefit when considering all events. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.