Zahra Notta

and 8 more

Patients with peripheral arterial disease (PAD) who have their lower extremities revascularized are nevertheless at increased risk for cardiovascular and thrombotic events. Aspirin and rivaroxaban combined antithrombotic therapies have demonstrated potential advantages over aspirin monotherapy. Hence, the purpose of this systematic review and meta-analysis is to compare the safety and effectiveness of rivaroxaban + aspirin versus aspirin alone. In accordance with PRISMA principles, randomized controlled trials (RCTs) comparing rivaroxaban (2.5 mg twice day) plus aspirin (100 mg daily) with placebo plus aspirin were included. Adverse events include significant bleeding (TIMI and ISTH criteria), cerebral hemorrhage, and fatal bleeding were among the primary outcomes. Acute limb ischemia (ALI), major amputation, myocardial infarction (MI), ischemic stroke, cardiovascular death, and composite outcomes were among the secondary outcomes that evaluated efficacy measures. There were three high-quality RCTs with a total of 20,594 patients. Aspirin and rivaroxaban together significantly decreased the incidence of composite cardiovascular events (RR = 0.83; 95% CI: 0.76–0.90; p < 0.0001) and acute limb ischemia (RR = 0.61; 95% CI: 0.51–0.72; p ≤ 0.00001). Although it was not statistically significant, there was a trend toward fewer ischemic strokes and MIs. While there were no appreciable changes in fatal bleeding or cerebral hemorrhage, the intervention group had higher major bleeding risks, such as TIMI (RR = 1.44; p = 0.008) and ISTH bleeding (RR = 1.37; p = 0.002). There was little publication bias and little heterogeneity among the majority of the results.