%0 Journal Article
%T Self
%A Akira Miyamoto
%A Hidehiko Hara
%A Hiroshi Ando
%A Junji Yajima
%A Kazushi Urasawa
%A Keisuke Hirano
%A Kimihiko Kichikawa
%A Masato Nakamura
%A Mitsuyoshi Takahara
%A Naoto Inoue
%A Osamu Iida
%A Shigeru Nakamura
%A Shinsuke Nanto
%A Takao Ohki
%A Toshiaki Mano
%A Yasuo Komura
%A Yoshiaki Yokoi
%A Yoshimitsu Soga
%A Yuki Horita
%J Journal of Endovascular Therapy
%@ 1545-1550
%D 2019
%R 10.1177/1526602819826591
%X 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¡À8 years; 36 men) in the stent group and 52 patients (mean age 73¡À8 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 <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. Results: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. Conclusion: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies
%K balloon angioplasty
%K endovascular treatment/therapy
%K femoropopliteal disease
%K self-expanding stent
%K patency
%K peripheral artery disease
%K popliteal artery
%K randomized controlled trial
%K superficial femoral artery
%K stent
%K target lesion revascularization
%U https://journals.sagepub.com/doi/full/10.1177/1526602819826591