Drug-eluting balloons for femoropopliteal lesions show better performance in de novo stenosis or occlusion than in restenosis

• Published in: Journal of vascular surgery 2015-02, Vol.61 (2), p.394-399
• Main Authors: Herten, Monika, PhD, Torsello, Giovanni B., PhD, Schönefeld, Eva, MD, Imm, Britta, Osada, Nani, PhD, Stahlhoff, Stefan, MD
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Angioplasty, Balloon - mortality; Cardiovascular Agents - administration & dosage; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Femoral Artery - physiopathology; Humans; Intermittent Claudication - diagnosis; Intermittent Claudication - mortality; Intermittent Claudication - physiopathology; Intermittent Claudication - therapy; Ischemia - diagnosis; Ischemia - mortality; Ischemia - physiopathology; Ischemia - therapy; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel - administration & dosage; Peripheral Arterial Disease - diagnosis; Peripheral Arterial Disease - mortality; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - therapy; Popliteal Artery - physiopathology; Prospective Studies; Recurrence; Stents; Surgery; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2014.08.005

Objective Although drug-eluting balloons (DEBs) have shown promising results treating de novo (DN) atherosclerotic lesions and appear to have been widely adopted in Europe, their long-term efficacy in the broad spectrum of femoropopliteal restenosis (RE) remains to be proven. The purpose of the study was to assess the efficacy of paclitaxel-DEBs in restenotic (stented and nonstented) vs DN stenotic femoropopliteal arteries. Methods The study prospectively enrolled 100 patients undergoing femoropopliteal endovascular intervention by DEB for RE or DN stenosis. Patients who received additive atherectomy were excluded. The primary end point was the primary patency (PP) rate at 12 months. Secondary end points were sustained clinical improvement and clinically driven target lesion revascularization. Results DEBs were used to treat 105 limbs for intermittent claudication (82 [78%]) or critical limb ischemia (23 [22%]) in 100 patients. Of these, 111 lesions were DN stenosis (46 [41%]) or RE (65 [59%]). The overall PP was 86% at 6 months and 74% at 12 months. PP of DN stenosis was higher at 6 months (93% vs 81%) and was significantly ( P  = .021) better than RE at 12 months (85% vs 68%). Sustained clinical improvement based on Rutherford classification was significant in both groups ( P  < .001). Target lesion revascularization was significantly lower in DN stenosis compared with RE at 12 months (15% vs 32%; P  = .021). Conclusions DEB angioplasty is an effective therapy for DN femoropopliteal lesions. The results of DEB angioplasty for RE are inferior compared with DN stenosis after 12 months. Nevertheless, results of DEB angioplasty for RE seem comparable with technically more demanding literature-derived strategies.