Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial

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. 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 [CT], 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 Ruthetford 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 turd Rutherford score with primary stent placement for SFA lesions.