Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial

• Published in: Journal of endovascular therapy 2019-04, Vol.26 (2), p.158-167
• Main Authors: Iida, Osamu, Urasawa, Kazushi, Komura, Yasuo, Soga, Yoshimitsu, Inoue, Naoto, Hara, Hidehiko, Yajima, Junji, Nakamura, Shigeru, Ohki, Takao, Ando, Hiroshi, Hirano, Keisuke, Horita, Yuki, Kichikawa, Kimihiko, Yokoi, Yoshiaki, Miyamoto, Akira, Nakamura, Masato, Takahara, Mitsuyoshi, Mano, Toshiaki, Nanto, Shinsuke
• Format: Article
• Language: English
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1177/1526602819826591

Purpose: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. Materials and Methods: The SM-01 study (ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio