Abstract 19556: Drug-Eluting Balloon versus Standard Balloon Angioplasty for Infrapopliteal Arterial Disease: Meta-Analysis of Randomized Control Trials
Introduction: Drug-eluting balloon (DEB) angioplasty has emerged as a valuable treatment option for peripheral artery disease. The role of DEBs in infrapopliteal arterial (IPA) disease is still controversial due to inconsistent results from the clinical trials. We hypothesized that DEBs would have favorable outcomes compared to standard balloon percutaneous transluminal angioplasty (PTA) for IPA disease.
Objective: We performed a meta-analysis of randomized control trials (RCT) comparing DEB vs. PTA in patients with IPA disease.
Methods and Results: Pubmed, Google Scholar and Embase databases were searched for RCTs comparing DEB vs. PTA in patients with IPA disease. Meta-analysis was done using a random effects size model and results were expressed in terms of Odds ratio (OR) and 95% Confidence interval (CI) after evaluating for interstudy heterogeneity using I2. We compared clinically driven target lesion revascularization (CD-TLR), amputation, death, major adverse events and late lumen loss between two groups.
Total number of patients in our study was 570 from 4 RTCs, with 341 patients in DEB group and 229 patients in PTA group. When compared to PTA, DEB did not show statistically significant benefit in terms of CD-TLR (OR=0.54, [ CI: 0.25,1.15], p=0.11), amputation (OR=1.17, [CI: 0.77,1.78], p=0.46 ), death (OR=1.40 ,[CI: 0.72,2.71], p=0.32 ), major adverse events (OR=0.65,[CI: 0.26,1.63], p=0.36) and late lumen loss (OR= -0.10,[CI: -0.41,0.21], p=0.53).
Conclusion: In patients with IPA disease, use of DEBs is associated with similar safety and efficacy outcomes compared to PTA. Studies with larger sample size are still needed to address the role of DEBs in patients with IPA disease.
Author Disclosures: V. Anugu: None. B. Pandya: None. S. Gaddam: None. N. Nalluri: None. D. Asti: None. R. Kandov: None. T. Vazzana: None. J. Lafferty: None.
- © 2016 by American Heart Association, Inc.