Fabrizio Fanelli, Vascular and Interventional Radiology Unit, Department of Radiological Sciences, “Sapienza” University of Rome, Italy, and colleagues selected 50 patients (37 men), who were randomly assigned to either conventional angioplasty (25 patients with 65 lesions) or the drug-eluting balloon (25 patients with 57 lesions) procedure. These patients presented a total of 122 lesions in the femoropopliteal (92, 75.4%) or below-the-knee (30, 24.6%) arteries. Some patients in each group required insertion of a stent after balloon dilation.
Late lumen loss at 6 months was the primary endpoint and target lesion revascularisation, amputation and thrombosis were assigned as secondary endpoints.
Six months after the procedure, the group treated with the drug eluting balloon showed better clinical outcomes than the group treated with conventional angioplasty. Late lumen loss was lower in the drug-eluting balloon group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). Target lesion revascularisation was necessary in 6.1% of the drug-eluting balloon group vs. 23.6% of the angioplasty balloon group. The thrombosis rates were 3.0% for the drug-eluting group vs. 5.2%, and the amputation rates were 3.0% for drug-eluting patients vs. 7.9%. The binary restenosis rates were 9.1% (3/33 limbs) in the drug-eluting balloon group vs. 28.9% (11/38 limbs) in the control group. Overall, the drug-eluting balloon group experienced better outcomes regardless of whether a stent had been placed.
Ramon L Varcoe (Department of Surgery, Prince of Wales Hospital, University of New South Wales and The Vascular Institute, Prince of Wales, Sydney, Australia) wrote in an accompany commentary: “The DEBELLUM trial has once again demonstrated that paclitaxel delivered to the site of vascular injury on the surface of an angioplasty balloon is effective in reducing neointimal hyperplasia and lumen stenosis in the first 6 months after intervention.” However, he cautioned that the procedure has yet to prove itself in the long term. It needs to be determined how this technology can be used most effectively and most cost-efficiently, he commented.