One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study).
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.
Department of Surgery, Division of Vascular Surgery, Jikei University School of Medicine, Tokyo, Japan. Electronic address: takohki@msn.com.
Takao
T
Ohki
Department of Radiology and Medical Imaging, Division of Interventional Radiology, Angiography and Special Procedures, University of Virginia Hospital Medical Center, Charlottesville, Va.
John F
JF
Angle
Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka, Japan.
Hiroyoshi
H
Yokoi
Paul and Phyllis Fireman Vascular Center, Massachusetts General Hospital, Boston, Mass.
Michael R
MR
Jaff
Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Mass.
Jeffrey
J
Popma
Berks Cardiologists, Ltd, Wyomissing, Pa.
Guy
G
Piegari
Department of Surgery, Division of Vascular Surgery, Jikei University School of Medicine, Tokyo, Japan.
Yuji
Y
Kanaoka
D000368:Aged; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000208:ethnology / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D056910:Republic of Korea; D012307:Risk Factors; D015607:Stents; D013624:Taiwan; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014654:Vascular Patency