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Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial |
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| Institution: | 1. Department of Radiology, Department of Radiology, Hospital Expansion, Room 4080, University of Virginia Hospital, University of Virginia Health System,1215 Lee St., Charlottesville, VA 22908-0170;2. Department of Radiology, University of Minnesota, Minneapolis, Minnesota;3. Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka, Japan;4. Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts;5. Newton-Wellesley Hospital, Newton, Massachusetts;6. Boulder Community Health, Boulder, Colorado;7. Department of Surgery, Jikei University, Tokyo, Japan;1. Department of Radiology, University of California, San Diego, Health Sciences, 200 W. Arbor Dr., San Diego, CA 92103-8756;2. Department of Radiology, Icahn School of Medicine, Mount Sinai Hospital, New York, New York;3. Department of Radiology, University of Minnesota, Minneapolis, Minnesota;4. Department of Radiology, Keck School of Medicine, University of Southern California, Los Angeles, California;5. Department of Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas;6. Department of Radiology, Naval Medical Center, San Diego, California;1. Department of Vascular Surgery, Ludwig-Maximilian University Hospital, Munich, Germany;2. Section of Angiology, Ludwig-Maximilian University Hospital, Munich, Germany;1. Division of Vascular and Endovascular Surgery, University of California, San Francisco, 400 Parnassus Ave., Fifth Floor, Suite A-501, San Francisco, CA 94143;2. Department of Surgery, Vascular Institute, Prince of Wales Hospital, University of New South Wales, Sydney, Australia;1. Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital, Linkou, No. 5, Fu-Hsing Street, Kuei-Shan Hsiang, Taoyuan Hsien, 333, Taoyuan, Taiwan;2. Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung Memorial Hospital, Linkou, No. 5, Fu-Hsing Street, Kuei-Shan Hsiang, Taoyuan Hsien, 333, Taoyuan, Taiwan;3. College of Medicine, Chang Gung University, Taoyuan, Taiwan |
| Abstract: | PurposeThis 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 MethodsThis 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.ResultsA 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).ConclusionsOSPREY (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. |
| Keywords: | ABI"} {"#name":"keyword" "$":{"id":"kwrd0015"} "$$":[{"#name":"text" "_":"ankle-brachial index BMS"} {"#name":"keyword" "$":{"id":"kwrd0025"} "$$":[{"#name":"text" "_":"bare metal stents CD-TLR"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"clinically driven target lesion revascularization DUS"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"duplex ultrasonography PAD"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"peripheral artery disease PTA"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"percutaneous transluminal angioplasty SFA"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"superficial femoral artery |
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