In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06% hazard ratio, 1.42 95% CI, 1.10 to 1.84 P=0.007). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87% hazard ratio, 1.43 95% CI, 0.97 to 2.10 P=0.07). The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group the Kaplan–Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval, 0.76 to 0.96 P=0.009). ResultsĪ total of 6564 patients underwent randomization 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The efficacy and safety of rivaroxaban in this context are uncertain. Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The most trusted, influential source of new medical knowledge and clinical best practices in the world.
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