6/30/23, 12:38 AM VOYAGER PAD Pathway Feedback Search Clinical Topics Home Studies VOYAGER PAD VOYAGER PAD Disease Peripheral artery disease of low Trial question What is the role of rivaroxaban in patients with PAD after revascularization? Study design Multi-center Double blinded RCT Population Characteristics of study participants 26.0% female N = 6564 74.0% male 6564 patients (1704 female, 4860 male) Inclusion criteria: patients aged 50 years with PAD who had undergone revascularization Key exclusion criteria: clinically unstable condition; high risk for bleeding; known liver disease with coagulopathy or bleeding risk; receipt or anticipated to begin receiving prohibited concomitant medications including long-term treatment with clopidogrel Interventions N=3286 rivaroxaban (oral dose of 2.5 mg BID plus aspirin) N=3278 placebo (oral dose of matching placebo BID plus aspirin) Primary outcome Composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes 19.9 % 19.9 17.3 14 9 % https://web.pathway.md/studies/reca5QvzXktWfpyCn 1/2 6/30/23, 12:38 AM 14.9 % VOYAGER PAD Pathway 9.9 % Significant decrease 5.0 % NNT = 38 0.0 % Rivaroxaban Placebo Significant decrease in composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes (17.3% vs. 19.9%; HR 0.85, 95% CI 0.76 to 0.96) Secondary outcomes Significant decrease in composite outcome of acute limb ischemia, major amputation for a vascular cause, myocardial infarction, ischemic stroke, or death from coronary heart disease (14.7% vs. 18.2%; HR 0.8, 95% CI 0.71 to 0.91) Significant decrease in unplanned index-limb revascularization for recurrent limb ischemia (20% vs. 22.5%; HR 0.88, 95% CI 0.79 to 0.99) Significant decrease in hospitalization for thrombotic coronary or peripheral event (8.7% vs. 12.1%; HR 0.72, 95% CI 0.62 to 0.85) Safety outcomes No significant difference in major bleeding according to the Thrombolysis In Myocardial Infarction classification or intracranial hemorrhage. Significant difference in major bleeding according to the International Society on Thrombosis and Hemostasis criteria (5.94% vs. 4.06%). Conclusion In patients aged 50 years with PAD who had undergone revascularization, rivaroxaban was superior to placebo with respect to the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. Reference Marc P Bonaca, Rupert M Bauersachs, Sonia S Anand et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. Open reference URL https://web.pathway.md/studies/reca5QvzXktWfpyCn 2/2