Rivaroxaban plus aspirin significantly reduced MACE compared to aspirin alone in patients with peripheral artery disease (RR 0.82; 95% CI 0.78-0.87), but increased the risk of major bleeding.
Meta-Analysis (n=90,325)
Does rivaroxaban plus aspirin reduce cardiovascular and limb events compared to aspirin alone in adults with peripheral artery disease?
In patients with peripheral artery disease, adding rivaroxaban to aspirin reduces major adverse cardiovascular events and acute limb ischemia but increases the risk of major bleeding.
Relative Risk: 0.82 (95% CI 0.78–0.87)
Background: Peripheral artery disease (PAD) is a prevalent atherosclerotic disorder associated with significant cardiovascular morbidity. Although aspirin remains the cornerstone of therapy, residual thrombotic risk persists. The addition of rivaroxaban, a factor Xa inhibitor, may enhance protection through dual pathway inhibition. This meta-analysis aimed to evaluate the efficacy and safety of rivaroxaban plus aspirin versus aspirin alone in patients with PAD. Methods: A systematic review and meta-analysis were conducted following PRISMA and AMSTAR guidelines. Randomized controlled trials comparing rivaroxaban plus aspirin with aspirin alone in adults with PAD were included. Data were pooled using a random-effects model in Review Manager 5.4. Risk of bias was assessed with RoB 2 and certainty of evidence was graded using GRADE pro. Results: Six RCTs including 90 325 participants met inclusion criteria. Combination therapy significantly reduced MACE (RR: 0.82, 95% CI: 0.78–0.87), MI (RR: 0.87), ischemic stroke (RR: 0.76), and acute limb ischemia (RR: 0.68), with low heterogeneity (≤35%). No significant reduction was observed in cardiovascular mortality or major amputation. TIMI major bleeding risk increased (RR: 1.41, 95% CI: 1.07–1.84), however intracranial and fatal bleeding rates were similar between groups. Moderate-to-high certainty evidence supports reductions in ischemic and limb events, with increased bleeding risk. Conclusion: Rivaroxaban plus aspirin is associated with improved cardiovascular and limb outcomes compared to aspirin alone in PAD, albeit with a higher risk of major bleeding. Findings should be interpreted in the context of potential publication bias and heterogeneity across trials. Careful patient selection is warranted for optimal risk-benefit balance.
Farhan et al. (Wed,) conducted a meta-analysis in Peripheral arterial disease (n=90,325). Rivaroxaban plus aspirin vs. Aspirin alone was evaluated on MACE (RR 0.82, 95% CI 0.78-0.87). Rivaroxaban plus aspirin significantly reduced MACE compared to aspirin alone in patients with peripheral artery disease (RR 0.82; 95% CI 0.78-0.87), but increased the risk of major bleeding.