Drug-Eluting Balloon for Below the Knee Angioplasty: Five-Year Outcome of the DEBATE-BTK Randomized Clinical Trial

Background The aim of this study is to evaluate the 5-year clinical outcome of the DEBATE-BTK (Drug-eluting balloon for below-the-knee angioplasty evaluation) trial. Methods The DEBATE-BTK was a single-center, randomized trial that enrolled 132 diabetic patients with critical limb ischemia. Subjects were randomized 1:1 to DCB or plain old balloon angioplasty (POBA). Major clinical endpoints were, freedom from all–cause death, freedom from clinically driven target lesion revascularization (CDTLR) and the occurrence of major amputation. Additional analysis were conducted to assess overall survival in patients treated with DCB compared to those treated with only POBA in the entire 5-years period and to test the correlation between paclitaxel dose exposure (in terciles) and overall survival. Results Freedom from all-cause death at 5 years was 63.1% (41/65) in DCB vs. 53.7%(35/67) POBA patients (p = 0.4). Freedom from CDTLR was 82% in DCB and 63% in POBA patients ( p = 0.002) at 1 year and 63 versus 54% at 5 years respectively P = 0.07. One patient in DCB and 2 patients in POBA underwent a major amputation of the target limb. During the 5-year follow-up, 24 patients originally randomized to POBA received DCB treatment for additional limb revascularization. According to DCB treatment in all the 5 years period, overall survival was 66.3.% (30/89) in DCB versus 40%(26/43) in POBA patients, p = 0.003. Conclusions Overall survival at 5-year was similar in DCB treated patients compared to POBA. Moreover, survival was higher in patients that received DCB angioplasty at any time of the 5 years period. Level of Evidence Level 1b, Individual inception cohort study with > 80% follow-up.