Efficacy and Safety of Rivaroxaban Therapy for Patients With Peripheral Artery Disease: A Systematic Review and Meta-Analysis.

OBJECTIVE

We performed a systematic review and meta-analysis to evaluate the efficacy and safety of rivaroxaban in patients with PAD for the first time.

METHODS

We searched MEDLINE, EMBASE and the Cochrane Library database for randomized controlled trials (RCTs) conducted for PAD.

RESULTS

Three trials which contained 14873 patients were included for final meta-analysis. The results showed patients with rivaroxaban was associated with reduction in primary efficacy outcome (RR 0.83; 95% CI 0.76 to 0.90; p < 0.001). The RR was 0.85 (0.71 to 1.01) for patients with rivaroxaban alone and 0.81 (0.74 to 0.89) for those with rivaroxaban plus aspirin (p for heterogeneity between groups = 0.65). Patients with rivaroxaban showed a lower rate of acute limb ischemia (0.56; 0.47 to 0.66; p < 0.001). There was a trend toward a reduction in the rate of major amputation for vascular causes in the rivaroxaban arm (0.81; 0.63 to 1.03; p = 0.08). Compared with control, rivaroxaban therapy did not reduce the risks of myocardial infarction (0.87, 0.73 to 1.04, p = 0.12), ischemic stroke (0.85, CI 0.68 to 1.06, p = 0.15), death from cardiovascular causes (0.99, 0.85 to 1.15, p = 0.91) or death from any cause (1.00, 0.90 to 1.12, p = 0.98). Rivaroxaban therapy was associated with a 1.57-fold higher major bleeding rate as compared with those with aspirin or warfarin alone.

CONCLUSIONS

Overall, the risks of the primary efficacy outcomes or adverse limb events were significantly lower with rivaroxaban than with aspirin or warfarin alone in patients with PAD. It also points out the significant major bleeding that occur because of such therapies.