Introduction: Peripheral artery disease (PAD) is a common manifestation of atherosclerosis, being associated with severe cardiovascular events. It has been shown that dual antiplatelet therapy (DAPT) is more effective in reducing the rate of ischemic vascular events than monotherapy with aspirin, but is associated with a higher risk of bleeding. DAPT in patients with PAD is still a controversial issue.
Methods: We performed a comprehensive metaanalysis of randomized controlled trials (RCTs) comparing DAPT vs aspirin monotherapy. The primary outcome was mortality.
Results: Ten RCTs including 66,194 patients were included. Compared with aspirin monotherapy, DAPT was associated with a significant reduction in mortality (odds ratio, 0.86; 95% confidence interval, 0.83-0.89; p<0.001) and in repeat revascularizations (odds ratio=0.80; 95% confidence interval=0.69-0.92; p=0.002). No significant increase in major bleeding complications was observed with DAPT vs aspirin monotherapy (odds ratio=1.21; 95% confidence interval=0.87-1.68; p=0.65). Results were consistent in different subgroups including those with symptomatic PAD and those treated with percutaneous angioplasty or bypass with no significant p for interaction.
Conclusions: The present metaanalysis demonstrated that DAPT as compared to aspirin monotherapy significantly improves survival in the wide spectrum of patients with PAD. The combination of aspirin with a second antiplatelet agent should be regarded as therapeutic mainstay in patients with PAD with or without invasive revascularizations.