European 1-Year Data Support Terumo’s Misago Stent in Femoral and Popliteal Arteries
December 6, 2012—In the Journal of Endovascular Therapy, Karl-Ludwig Schulte, MD, et al published results of the European MISAGO 2 clinical trial (2012;19:774–784). MISAGO 2 is evaluating the Misago self-expanding rapid-exchange nitinol stent system (Terumo Europe N.V., Leuven, Belgium). The investigators concluded that the device showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.
As detailed in the Journal of Endovascular Therapy, between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. The mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months after intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed.
The investigators reported that in the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year (3.1% among 709 [95.3%] patients at 6 months). Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in 76% of the patients over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, two grade 2) in 3.1% of stents examined radiographically (n = 484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year after the procedure.
In an accompanying commentary in the Journal of Endovascular Therapy, Ehrin J. Armstrong, MD, and John R. Laird, MD, discuss the strengths and weaknesses of the MISAGO 2 research (2012;19:785–787). Drs. Armstrong and Laird noted that other clinical trials have had similar positive results. They stated that a number of stents have shown efficacy, and alternative technologies, including drug-eluting stents and balloons, are now available. Drs. Armstrong and Laird concluded that, “the time has come for comparative trials with clinically meaningful outcomes.”