March 28, 2020New England Journal of Medicine1,015 citationsOpen Access
Rivaroxaban in Peripheral Artery Disease after Revascularization
View Full Paper
Structured PICO
Does rivaroxaban plus aspirin reduce the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes in patients with peripheral artery disease who had undergone lower-extremity revascularization?
P
Population
Patients with peripheral artery disease who had undergone lower-extremity revascularization
I
Intervention
Rivaroxaban 2.5 mg twice daily plus aspirin
C
Comparator
Aspirin alone
O
Outcome
Composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causescomposite
In patients with peripheral artery disease post-revascularization, adding rivaroxaban 2.5 mg twice daily to aspirin significantly reduces major adverse limb and cardiovascular events but increases ISTH major bleeding.
Abstract
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. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).