Background: The aim of this meta-analysis was to compare the angiographic outcomes in patients with femoropopliteal artery disease treated with either paclitaxel-coated balloon (PCB) or with standard balloon angioplasty (SBA).
Methods: A systematic literature search was performed in PubMed and EMBASE database for clinical trials evaluating femoropopliteal artery disease interventions. Angiographic outcomes were compared. We conducted meta-analysis assuming random effects by using RevMan (Version 5.3.5 Copenhagen, Denmark). Results were calculated with 95% CI and was considered statistically significant if 2–sided alpha error was <.05.
Results: A total of 9 studies (n=1,361) were included in the meta-analysis. Average follow-up was 18 months. Compared to SBA, PCB treated patients had significant reduction in target revascularization rates (OR 0.28 [0.17-0.45], P < 0.00001), binary restenosis (OR 0.33 [0.23-0.50], P <0.00001), and late lumen loss (mean difference [95% CI]: -0.53 [-0.75 to -0.31] mm, P <0.00001).
Conclusion: Using PCB for treating femoropopliteal artery occlusion led to a significant reduction in target lesion revascularization, binary restenosis and late lumen loss compared to SBA. More studies are needed to assess the long-term angiographic and clinical outcomes in this high-risk population.