Twelve years ago, controversial clinical trial results caused an international medical society to warn against the use of stents in leg arteries. But recent years have brought significant improvements in stent technology. One-year follow-up results of a worldwide, multicenter trial with 744 patients show that 90% participants had successful procedures that did not require a repeat treatment.
The Journal of Endovascular Therapy recently published the results of the clinical trial of the Misago self-expanding rapid-exchange nitinol stent system. The Misago 2 study included 744 patients with at least 70% occlusion of the femoral or popliteal arteries who were treated in 76 medical centres worldwide.
Success of the procedures was assessed at 6 and 12 months following stent placement.
The use of balloon angioplasty in the peripheral arteries has proven safe and effective – at least in the short term. High plaque burden, low blood flow velocities, and lesion length present obstacles to the success of this technique. The additional placement of a stent can prevent recoil of the dilated vessel, limit residual stenosis, and decrease the risk of dissection.
Since the 2000 TransAtlantic Inter-Society Consensus Working Group discouraged femoropopliteal stenting as a primary therapy, much progress has been made. In several clinical trials, self-expanding nitinol stents have shown improved intermediate outcomes. At the 1-year follow-up, the Misago 2 study found an overall revascularisation rate of 10%. Event-free survival was 85%. Significant improvements were noted for patients’ ischaemic symptoms and pain-free walking distances. With a low incidence of complications, the study raised no safety concerns for use of the Misago system.
The authors of an accompanying commentary discussed strengths and weaknesses of this research and pointed out that other clinical trials have had similar positive results. A number of stents have shown efficacy, and a number of alternative technologies, including drug-eluting stents and balloons, are now available.
