Paclitaxel-coated balloon reduces target lesion revascularization compared with standard balloon angioplasty.

OBJECTIVE: Peripheral arterial disease (PAD) is a highly prevalent condition that contributes significantly to the morbidity and mortality of affected patients. PAD creates a significant economic burden on health care systems around the world. We reviewed all available literature to provide a meta-analysis assessing the outcome of patients treated with drug-eluting balloons (DEBs) compared with percutaneous transluminal balloon angioplasty (PTA) through measuring the rate of target lesion revascularization (TLR).

METHODS: An electronic search of the MEDLINE, Scopus, Embase, Web of Science, and Cochrane Library databases was performed. Articles reporting randomized controlled trials that compared treatment with DEBs vs PTA were selected for inclusion. A meta-analysis was performed by pooling data on rates of TLR, binary restenosis (BR), and late lumen loss (LLL).

RESULTS: The 10 included articles comprised a sample size of 1292 patients. Meta-analysis demonstrated the rate of TLR in DEB-treated patients was significantly lower compared with patients treated with PTA at 6 months (odds ratio [OR], 0.24; 95% confidence interval [CI], 0.11-0.53; P = .0004), 12 months (OR, 0.28; 95% CI, 0.13-0.62; P = .002), and 24 months (OR, 0.25; 95% CI, 0.10-0.61; P = .002). Decreased LLL and BR was demonstrated at 6 months in patients treated with DEBs compared with patients treated with PTA (mean difference, -0.74; 95% CI, -0.97 to -0.51; P = .00001; OR, 0.34; 95% CI, 0.23-0.49; P = .00001).

CONCLUSIONS: This meta-analysis demonstrates that treatment with DEBs compared with PTA results in reduced rates of reintervention in patients with PAD. Comparison of DEBs to other emerging treatments to determine which method results in the lowest reintervention rates and in the greatest improvement in quality of life should be the focus of future trials.