IF03. Prospective Randomized Controlled Trial Comparing Drug-Eluting Versus Conventional Balloon Angioplasty Below the Knee in Critical Limb Ischemia: The 6-Month Results

Abstract

To report the 6-month Results of a prospective randomized, controlled trial comparing drug-eluting balloon (DEB) angioplasty versus conventional balloon (CB) angioplasty for below the knee arteries in patients with critical limb ischemia (CLI). In this investigator-initiated, prospective, multicenter, randomized controlled trial (NCT02129634), 138 CLI patients (93 males and 45 females) with a mean age of 62.6 years (standard deviation [SD], 9.9), were randomized 1:1 to either DEB group (n = 70) or CB group (n = 68). Of these patients, 94.2% were diabetics and 52.9% had end-stage renal failure. The primary end point was angiographic primary patency rate of target lesions at 6 months. Efficacy analysis was analyzed by generalized linear model adjusted for end-stage renal failure status in an intention-to-treat population. Missing data for primary end point was imputed by multiple imputation. Patient demographics were similar between the two groups. The mean lesion length treated was 90.3 mm (SD, 73.9) for the DEB group and 81.8 mm (SD, 71.8) for the CB group (difference, 8.5 mm; 95% confidence interval [CI], -16.2 to 33.2; P = .498). There was no statistical difference in the 6-month angiographic patency rates (DEB 41.9% vs CB 37.8%; risk difference, 6.2%; 95% CI, -11.0% to 23.4%; P = .479) and 6-month limb salvage rates (DEB 77.9% vs CB 84.8%; risk difference, 8.8%; 95% CI, -21.7% to 4.7%; P = .188). The 6-month amputation-free survival was worse in the DEB group and the difference was statistically significant (DEB 69.6% vs CB 80.3%; P = .030). The serious adverse event rate at 6 months was similar between the two groups. Our data showed no statistically significant differences in 6-month target lesion angiographic patency and limb salvage rate between DEB and CB groups in below the knee angioplasty for CLI. However, the 6-month amputation-free survival is significantly worse in the DEB group.