- Question
- Does adding low-dose rivaroxaban to aspirin reduce major limb and cardiovascular events in patients with peripheral artery disease who have undergone lower-extremity revascularization?
- Design
- International, multicenter, randomized, double-blind, placebo-controlled phase 3 trial enrolling 6564 patients.
- Population
- Patients with symptomatic peripheral artery disease who had undergone a lower-extremity revascularization procedure.
- Intervention
- Rivaroxaban 2.5 mg twice daily plus aspirin.
- Control
- Placebo plus aspirin.
- Primary outcome
- Composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes.
- Results
- The primary outcome occurred in 508 patients with rivaroxaban and 584 with placebo; the estimated 3-year incidence was 17.3% versus 19.9% (HR 0.85; 95% CI 0.76 to 0.96; P = 0.009).
- Safety
- TIMI major bleeding (the principal safety outcome) did not differ significantly: 2.65% with rivaroxaban versus 1.87% with placebo (HR 1.43; 95% CI 0.97 to 2.10; P = 0.07). ISTH major bleeding was higher with rivaroxaban: 5.94% versus 4.06% (HR 1.42; 95% CI 1.10 to 1.84; P = 0.007).
- Conclusion
- In patients with peripheral artery disease after revascularization, rivaroxaban 2.5 mg twice daily plus aspirin significantly reduced limb and cardiovascular ischemic events compared with aspirin alone, at the cost of more ISTH major bleeding.
- Why it matters
- It showed that a low-dose dual-pathway antithrombotic strategy can improve outcomes after peripheral revascularization, a high-risk setting with few pharmacologic options, while requiring clinicians to weigh the ischemic benefit against the higher bleeding risk.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026