Meta-Analysis Comparing Drug-Coated Balloons and Percutaneous Transluminal Angioplasty for Infrapopliteal Artery Disease.

Limited data is available regarding the safety and effectiveness of drug-coated balloon (DCB) versus conventional percutaneous transluminal balloon angioplasty (PTA) in the treatment of critical limb ischemia because of infrapopliteal peripheral arterial disease. We conducted an updated meta-analysis to assess the safety and efficacy of DCB in the treatment of infrapopliteal disease. A database search of PubMed/MEDLINE, EMBASE, and the Cochrane Library was performed by 2 reviewers from inception through November 15, 2021. Randomized trials that compared DCB with conventional PTA in treating infrapopliteal arterial disease were included. The risk ratios (RRs) and 95% confidence intervals (CIs) were reported. A total of 9 trials were included (1,501 participants) in the study. The mean age was 71.1 ± 10.2 years. Regarding the primary end points, treating infrapopliteal arterial disease with DCB had a lower incidence of re-stenosis (RR 0.48, 95% CI 0.33 to 0.70, p = 0.0001) with no significant difference in all-cause mortality (RR 1.11, 95% CI 0.73 to 1.69, p = 0.61), compared with conventional PTA. With regards to the secondary end points, DCB usage was associated with a significant reduction in clinically driven target lesion revascularization (RR 0.54, 95% CI 0.35 to 0.84, p = 0.006) with no significant difference with regards to major target limb amputation and major adverse cardiovascular events (p ≥0.05). In conclusion, among patients with critical limb ischemia secondary to infrapopliteal artery disease, DCB usage was associated with a significantly lower number of restenosis and clinically driven target lesion revascularization compared with conventional PTA. There was no increase in all-cause mortality or major target limb amputation with the use of DCB.