Published 1-Year DEBATE-BTK Results Support DEB Treatment of Diabetic CLI Patients

June 24, 2013—Francesco Liistro, MD, et al published the findings from the DEBATE-BTK study online ahead of print in Circulation.  DEBATE-BTK (Drug-Eluting Balloon in Peripheral Intervention for Below-the-Knee Angioplasty Evaluation) is a randomized, open-label, single-center study comparing endovascular intervention with a drug-eluting balloon (DEB) versus percutaneous transluminal angioplasty (PTA) in diabetic patients with critical limb ischemia (CLI).

Diabetic CLI patients were treated with the In.Pact Amphirion paclitaxel-eluting balloon (Medtronic Invatec, Frauenfeld, Switzerland) or a conventional uncoated Amphirion Deep balloon (Medtronic Invatec). The background of the study noted that 1-year restenosis rates after balloon angioplasty of long lesions in BTK arteries may be as high as 70%.

The 1-year DEBATE-BTK data were first presented in November 2011 at the TCT 2011: Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

As summarized in Circulation, inclusion criteria for DEBATE-BTK were: diabetes, CLI (Rutherford ≥ 4), significant stenosis or occlusion > 40 mm of at least one BTK vessel with distal run-off, and life expectancy > 1 year. Binary in-segment restenosis at 1-year angiographic or ultrasonographic follow-up was the primary endpoint. Clinically driven target lesion revascularization (TLR), major amputation, and target vessel occlusion were the secondary endpoints.

The study enrolled 132 patients with 158 infrapopliteal atherosclerotic lesions. Mean length of the treated segments was 129 ± 83 mm in the DEB group versus 131 ± 79 mm in the PTA group (P = .7).

The investigators reported that binary restenosis, assessed by angiography in > 90% of patients, occurred in 20/74 (27%) lesions in the DEB group versus 55/74 (74%) lesions in the PTA group (P < .001); TLR in 12 (18%) versus 29 (43%) (P = .002); and target vessel occlusion in 12 (17%) versus 41 (55%) (P < .001). There was one major amputation, which occurred in the PTA group (P = .9).

In DEBATE-BTK, DEB, as compared to PTA, reduced 1-year restenosis, TLR, and target vessel occlusion in the treatment of BTK lesions in diabetic patients with CLI, concluded the investigators in Circulation.