2-Year Results of Paclitaxel-Eluting Balloons for Femoropopliteal Artery Disease

• Published in: JACC. Cardiovascular interventions 2013-03, Vol.6 (3), p.282-289
• Main Authors: Micari, Antonio, MD, PhD, Cioppa, Angelo, MD, Vadalà, Giuseppe, MD, Castriota, Fausto, MD, Liso, Armando, MD, Marchese, Alfredo, MD, Grattoni, Chiara, MD, Pantaleo, Paolo, MD, Cremonesi, Alberto, MD, Rubino, Paolo, MD, Biamino, Giancarlo, MD, PhD
• Format: Article
• Language: English
• Subjects: angioplasty; Cardiovascular; drug-eluting balloon; percutaneous transluminal angioplasty; peripheral artery disease
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2013.01.128

Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.