Drug coated balloons: Superior in infrapopliteal territory?

Original Title: Drug-Coated Balloons for Revascularization of Infrapopliteal Arteries. A Meta-Analysis of Randomized Trials.
Reference: Salvatore Cassese et al. J Am Coll Cardiol Intv. 2016. Online before print.



The aim of this study was to perform a meta-analyzis of the most relevant randomized trials on the use of drug coated balloons (DCBs) in infrapopliteal lesions published so far. The use of DCBs in infrapopliteal lesions is still controversial and their efficacy remains unclear.

Safety and efficacy end points were the need for repeat revascularization and amputation, respectively. Secondary end points were death, major adverse events, Rutherford class 5 or 6 and late lumen loss.

The study included 641 patients enrolled in 5 trials that had randomized to DCB (n=378) vs. control (conventional balloons or DES; n=263).
Mean follow up was 12 months.

Patients treated with DES had repeat revascularization risk (RR 0.71; CI 95% 0.47 to 1.09; p=0.12), amputation (RR 1.01; CI 95% 0.65 to 1.58; p=0.95), death (RR 1.14; CI 95% 0.71 to 1.82; p=0.59), major adverse events (RR 0.92; CI 95% 0.59 to 1.43; p=0.70) and Rutherford class 5 or 6 rates (RR 0.87; IC 95% 0.46 to 1.62; p=0.65) comparable to those of the control group.

The advantage of DCBs was evident only looking at late lumen loss vs. control group (p = 0.04).



DCBs are associated to similar clinical results at one year, compared to conventional balloons or DES, in treating infrapopliteal lesions.


Editorial Comment
The limited number of patients and, mainly, the lack of standardized wound management in most studies, make it difficult to reach a definitive conclusion.