Author + information
- Received September 9, 2011
- Revision received November 16, 2011
- Accepted November 24, 2011
- Published online March 1, 2012.
- Antonio Micari, MD, PhD⁎,⁎ (, )
- Angelo Cioppa, MD†,
- Giuseppe Vadalà, MD⁎,
- Fausto Castriota, MD‡,
- Armando Liso, MD§,
- Alfredo Marchese, MD∥,
- Chiara Grattoni, MD‡,
- Paolo Pantaleo, MD¶,
- Alberto Cremonesi, MD‡,
- Paolo Rubino, MD† and
- Giancarlo Biamino, MD, PhD†
- ↵⁎Reprint requests and correspondence:
Dr. Antonio Micari, Maria Eleonora Hospital, Viale Regione Siciliano 1571, 90135 Palermo, Italy
Objectives This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease.
Background Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described.
Methods This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed.
Results The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up.
Conclusions PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.
Dr. Micari is a Medtronic consultant. Drs. Castriota and Cremonesi have reported relationships with Medtronic, Invatec, and Boston Scientific. Dr. Biamino is a consultant for Spectranetics and Igaki; and is proctor for Proctor EV3 and Hexacath. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 9, 2011.
- Revision received November 16, 2011.
- Accepted November 24, 2011.
- American College of Cardiology Foundation