One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease ( XXXX study).

@entity1 @entity174 @entity75 @entity715 @entity24201
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 @entity1 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 261subjects 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 @entity1 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 @entity75 revascularization were 82.9% and 13.0%, respectively. Regional differences within the Occlusive/Stenotic Peripheral Artery Revascularization Study ( @entity24201 ) and outcomes between U.S. and Asian @entity1 were similar, including primary patency (82.9% vs 83.0%; P  = .889), clinically driven @entity75 revascularization (13.4% vs 11.7%; P  = .829), stent @entity174 rate (1.3% vs 0.0%; P  = 1.000), and stent @entity715 rate (0.5% vs 0.0%; P  = 1.000). CONCLUSIONS: @entity24201 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.
