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DEB outperformed PTA in diabetic patients with below-the-knee lesions
Drug-eluting balloons reduced 1-year restenosis, target lesion revascularization and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia compared with percutaneous transluminal angioplasty, results from the DEBATE-BTK study showed.
Researchers of the randomized, open-label, single-center study enrolled 132 patients with 158 infrapopliteal atherosclerotic lesions. Patients had diabetes, critical limb ischemia (Rutherford ≥4), significant stenosis or occlusion >40 mm of at least one below-the-knee vessel with distal runoff, and life expectancy more than 1 year.
Binary restenosis occurred in 27% of lesions in the DEB group vs. 74% of lesions in the percutaneous transluminal angioplasty (PTA) group (P<.001). Compared with the PTA group, those in the DEB group had significantly lower rates of TLR (18% vs. 43%; P=.002) and target vessel occlusion (17% vs. 55%; P<.001). There was one major amputation in the PTA group and none in the DEB group.
Researchers said the high frequency of angiographic follow-up in the study and the very low rate of bailout treatment with drug-eluting stents (1.3% for each group) ensured reliability of the study results.
“Besides major amputation, our study did not have pre-planned endpoints of minor amputation and healing due to the fact that vessel patency alone is considered necessary but not sufficient to guarantee amputation-free survival,” they wrote. “However, post-hoc analysis revealed that DEB are likely to provide significant improvement in the rate of complete index ulcer healing at 12 months.”
Disclosure: Researchers reported no relevant financial disclosures.
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The Achilles heel of angioplasty for below-the-knee interventions is the high restenosis and reocclusion rates. In the randomized DEBATE-BTK trial, Liistro and colleagues demonstrated significant patency benefits with the use of DEB in complex tibial interventions, with a 27% restenosis rate in the DEB arm compared with a 74% rate in the regular PTA arm. This study further refines how below-the-knee lesions should be treated.