Safety and efficacy of drug‐coated balloon for peripheral artery revascularization—A systematic review and meta‐analysis

Abstract Background The relative merits of the drug‐coated balloon (DCB) versus uncoated balloon (UCB) angioplasty in endovascular intervention for patients with symptomatic lower extremity peripheral arterial disease (PAD) remains controversial. Methods Online databases were queried with various combinations of keywords to identify relevant articles. Net adverse events (NAEs) and its components were compared using a random effect model to calculate unadjusted odds ratios (ORs). Results A total of 26 studies comprising 26,845 patients (UCB: 17,770 and DCB: 9075) were included. On pooled analysis, DCB was associated with significantly lower odds of NAE (OR: 0.47, 95% confidence interval [CI]: 0.36–0.61), vessel restenosis (OR: 0.46, 95% CI: 0.37–0.57), major amputation (OR: 0.68, 95% CI: 0.47–99), need for repeat target lesion (OR: 0.38, 95% CI: 0.31–0.47) and target vessel revascularization (OR: 0.62, 95% CI: 0.47–0.81) compared with UCB. Similarly, the primary patency rate was significantly higher in patients undergoing DCB angioplasty (OR: 1.44, 95% CI: 1.19–1.75), while the odds for all‐cause mortality (OR: 0.96, 95% CI: 0.85–1.09) were not significantly different between the two groups. A subgroup analysis based on follow‐up duration (6 months vs. 1 vs. 2 years) followed the findings of the pooled analysis with few exceptions. Conclusions The use of DCB in lower extremity PAD intervention is associated with higher primary patency, lower restenosis, lower amputation rate, and decreased need for repeat revascularization with similar all‐cause mortality as compared to UCB.