BackgroundThis quantitative meta-analysis was conducted to evaluate the efficacy and safety of drug-eluting balloon (DEB) vs. uncoated balloon (UCB) in patients with femoropopliteal arterial occlusive disease.MethodsElectronic databases were searched to identify randomized controlled trials (RCTs) that compared DEB and UCB till November 2018. The random-effects model was used for conducting pooled analyses.ResultsSeventeen RCTs with 2706 patients were included in the final meta-analysis. Patients who received DEB had higher levels of minimal luminal diameter (MLD) at 6 (WMD: 0.77; 95%CI: 0.53 to 1.02; P<0.001) and 12months (WMD: 1.33; 95%CI: 0.93 to 1.73; P<0.001) than those who received UCB. DEB reduced the late lumen loss (LLL) levels after 6 (WMD: -0.57; 95%CI: -1.07 to -0.06; P=0.029) and 12months (WMD: -0.95; 95%CI: -1.28 to -0.62; P<0.001). DEB was found not superior over UCB on primary patency after 6months (RR: 1.44; 95%CI: 0.88-2.35; P=0.149), whereas DEB increased the primary patency after 12 (RR: 1.51; 95%CI: 1.25-1.83; P<0.001) and 24months (RR: 1.51; 95%CI: 1.30-1.77; P<0.001). Patients who received DEB had reduced the risk of restenosis after 6 (RR: 0.47; 95%CI: 0.33-0.67; P<0.001) and 12months (RR: 0.55; 95%CI: 0.35-0.85; P=0.008). DEB reduced the risk of major adverse events after 6 (RR: 0.30; 95%CI: 0.14-0.61; P=0.001), 12 (RR: 0.49; 95%CI: 0.32-0.76; P=0.001) and 24months (RR: 0.62; 95%CI: 0.41-0.92; P=0.018).ConclusionsDEB yielded additional benefits on MLD, LLL, primary patency, restenosis, TLR, and major adverse events than UCB in patients with femoropopliteal arterial occlusive disease.