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Objective: We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms., Methods: This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture., Results: One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years., Conclusions: This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: This study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication., Materials and Methods: This was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture., Results: A total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%-83.0%) at 24 months and 75.4% (95% CI, 69.6%-80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (-0.1 ± 0.2) and 1.5 (-0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients)., Conclusions: OSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to assess the safety and efficacy of the Misago stent (Terumo Corp, Tokyo, Japan) in occlusive and stenotic superficial femoral artery (SFA) disease., Methods: The safety and efficacy of the Misago SFA stent were evaluated prospectively in this initial collaboration trial between Japan and the United States. Because this trial enrolled patients mainly from Japan and the United States and because there is a question as to whether a race difference exists in SFA stent performance, the race difference on outcome was also analyzed. In addition, results were compared with a prior SFA stent trial., Results: The Misago stent was implanted in 261 subjects with TransAtlantic Inter-Society Consensus (TASC) type A and type B SFA lesions (201 subjects in the United States, 50 in Japan, 9 in Taiwan, 1 in South Korea). The mean age of the patients was 69.3 ± 10.0 years, and the mean lesion length was 83.8 ± 41.3 mm. The overall 12-month primary patency rate and clinically driven target lesion revascularization were 82.9% and 13.0%, respectively. Regional differences within the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) and outcomes between U.S. and Asian patients were similar, including primary patency (82.9% vs 83.0%; P = .889), clinically driven target lesion revascularization (13.4% vs 11.7%; P = .829), stent fracture rate (1.3% vs 0.0%; P = 1.000), and stent thrombosis rate (0.5% vs 0.0%; P = 1.000)., Conclusions: OSPREY 12-month data showed satisfactory outcome of the Misago stent for the treatment of TASC type A and type B SFA lesions and appears to be comparable to recent stent trials. In addition, the lack of difference in outcome among races supports the value of international trials., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective, multinational, randomized controlled trial (ClinicalTrials.gov identifier NCT00120406) evaluating a paclitaxel-coated drug-eluting stent (DES) compared to percutaneous transluminal angioplasty (PTA) for treating peripheral artery disease., Methods: Patients were randomly assigned to primary DES or PTA. In the Japanese cohort, 27 patients (21 men; mean age 71.2±9.6 years) were randomized to PTA and 25 patients (19 men; mean age 69.8±10.2 years) to primary DES. In the non-Japanese cohort, 211 patients (131 men; mean age 67.3±10.6 years) were randomized to PTA and 211 patients (136 men; mean age 67.6±9.5 years) to primary DES. Outcome measures included event-free survival (EFS), freedom from target lesion revascularization (TLR), patency, stent fracture, and sustained clinical benefit through 2 years., Results: Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts, although the outcomes in the Japanese cohort treated with primary DES were numerically better. In the DES group, the 2-year EFS was 92.0% vs. 85.0% (p=0.61), freedom from TLR was 96.0% vs. 85.5% (p=0.55), primary patency was 80.0% vs. 74.3% (p=0.61), and clinical benefit was sustained in 88.5% vs. 80.5% of patients (p=0.31) in the Japanese and non-Japanese cohorts, respectively. Stent fractures were seen in 4 of 457 stents at 12 months: 3 in the Japanese cohort and 1 in the non-Japanese cohort., Conclusion: The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries. The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials.