DefinePK

Abstract

Background: Recent trials demonstrated favorable results with drug-coated-balloons (DCB) in femoro-popliteal lesions. Additional vessel preparation with a scoring-balloon prior to DCB-angioplasty might reduce rates of flow-limiting dissections and subsequent need for bail-out stenting due to a controlled laceration of the intimal layer. However, clinical data for this combined procedure are lacking.
Methods: In a single center registry, 20 consecutive patients with femoro-popliteal lesions were treated with a scoring-balloon (VascuTrak®) and a DCB subsequently. The primary endpoint was the clinically driven target lesion revascularization (TLR). Secondary endpoints were clinically driven target vessel revascularization (TVR), binary restenosis (PSV>2.4), change in rutherford classification and ABI. Safety endpoints were major cardiovascular events (cardiovascular death, MI, stroke, death) and need for amputation.
Results: The procedure was successful in 17 patients, 1 patient was lost to follow-up. Therefore 16 patients (4 female) were analyzed at the 6 months follow-up visit. There were no clinically driven TLR or TVR after 6 months. Rutherford classification improved from 3.5±0.97 to 0.88±0.72 (p<0.01) after 6 months. ABI increased from 0.85±0.26 to 1.02±0.19 (p=0.01) after the procedure with no further change at 6 months (1.01±0.15, p=0.83). Duplex ultrasound was performed in 9 patients at 6 months, with one binary restenosis (11%). There were neither major cardiovascular events nor amputations at 6 months follow-up.
Conclusions: Vessel preparation with a scoring-balloon prior to DCB-angioplasty in femoro-popliteal lesions is suggested to improve clinical outcome of patients without any safety concerns. Further trials with more patients are needed for validation of the results of our registry.