Ohki Takao, Angle John F, Yokoi Hiroyoshi, Jaff Michael R, Popma Jeffrey, Piegari Guy, Kanaoka Yuji
Department of Surgery, Division of Vascular Surgery, Jikei University School of Medicine, Tokyo, Japan.
Department of Radiology and Medical Imaging, Division of Interventional Radiology, Angiography and Special Procedures, University of Virginia Hospital Medical Center, Charlottesville, Va.
J Vasc Surg. 2016 Feb;63(2):370-6.e1. doi: 10.1016/j.jvs.2015.08.093. Epub 2015 Oct 17.
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.
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.
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).
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.
本研究旨在评估Misago支架（日本东京泰尔茂公司）治疗股浅动脉（SFA）闭塞性和狭窄性疾病的安全性和有效性。
在日本和美国之间的这项初步合作试验中，对Misago SFA支架的安全性和有效性进行了前瞻性评估。由于该试验主要招募来自日本和美国的患者，并且存在SFA支架性能是否存在种族差异的问题，因此还分析了结果的种族差异。此外，将结果与先前的SFA支架试验进行了比较。
Misago支架植入了261例患有跨大西洋跨学会共识（TASC）A型和B型SFA病变的受试者（美国201例，日本50例，台湾9例，韩国1例）。患者的平均年龄为69.3±10.0岁，平均病变长度为83.8±41.3mm。总体12个月的主要通畅率和临床驱动的靶病变血运重建率分别为82.9%和13.0%。闭塞/狭窄性外周动脉血运重建研究（OSPREY）中的区域差异以及美国和亚洲患者之间的结果相似，包括主要通畅率（82.9%对83.0%；P = 0.889）、临床驱动的靶病变血运重建率（13.4%对11.7%；P = 0.829）、支架骨折率（1.3%对0.0%；P = 1.000）和支架血栓形成率（0.5%对0.0%；P = 1.000）。
OSPREY 12个月的数据显示，Misago支架治疗TASC A型和B型SFA病变的结果令人满意，并且似乎与最近的支架试验相当。此外，种族之间结果缺乏差异支持了国际试验的价值。
