Antonio Micari1, Giuseppe Vadalà2, Fausto Castriota3, Armando Liso4, Chiara Grattoni3, Paolo Russo5, Alfredo Marchese6, Paolo Pantaleo7, Giuseppe Roscitano2, Bruno Mario Cesana8, Alberto Cremonesi3. 1. Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Eleonora Hospital, Palermo, Italy. Electronic address: micariantonio@gmail.com. 2. Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Eleonora Hospital, Palermo, Italy. 3. Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Cecilia Hospital, Cotignola, Italy. 4. Cardiology Unit, Gruppo Villa Maria Care and Research, Città di Lecce Hospital, Lecce, Italy. 5. Gruppo Villa Maria Care and Research, Maria Pia Hospital, Torino, Italy. 6. Gruppo Villa Maria Care and Research, Anthea Hospital, Bari, Italy. 7. Gruppo Villa Maria Care and Research, Instituto Clinico Ligure di Alta Specialita, Rapallo, Italy. 8. Biostatistics and Biomathematics Unit, University of Brescia, Brescia, Italy.
Abstract
OBJECTIVES: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. BACKGROUND: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. RESULTS: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. CONCLUSIONS: Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).
OBJECTIVES: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. BACKGROUND: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. RESULTS: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. CONCLUSIONS:Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).
Authors: Ali F AbuRahma; Zachary T AbuRahma; Grant Scott; Elliot Adams; Matthew Beasley; Meghan Davis; L Scott Dean; Elaine Davis Journal: J Vasc Surg Date: 2019-08-08 Impact factor: 4.268
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Authors: Thomas Zeller; Ralf Langhoff; Krishna J Rocha-Singh; Michael R Jaff; Erwin Blessing; Beatrice Amann-Vesti; Marek Krzanowski; Patrick Peeters; Dierk Scheinert; Giovanni Torsello; Sebastian Sixt; Gunnar Tepe Journal: Circ Cardiovasc Interv Date: 2017-09 Impact factor: 6.546