Treatment of the femoropopliteal artery with the bioresorbable REMEDY stent.

OBJECTIVE: Bioresorbable stents are an emerging technology in the endovascular treatment of femoropopliteal lesions. They address the issue of leaving permanent stents in the treated arterial segment that are only temporarily needed to treat dissection or recoil. The REMEDY stent (Kyoto Medical Planning Co, Kyoto, Japan) was the first commercially available biodegradable scaffold for peripheral use. We evaluated its performance and safety in the treatment of short femoropopliteal stenosis or occlusion.

METHODS: A prospective, multicenter, observational registry was set up of patients in Rutherford-Becker categories 2 to 5 with femoropopliteal lesions that could be treated with one REMEDY stent. Clinical examination and duplex ultrasound imaging were performed at 1, 6, and 12 months. The primary end point was absence of clinically driven target lesion revascularization at 12 months. Secondary end points were technical and clinical success, primary and secondary patency rate, clinically driven target vessel revascularization, major complications, and Rutherford-Becker classification at 6 and 12 months.

RESULTS: The registry enrolled 99 patients between January 2011 and July 2013 in 12 centers in Belgium. Most lesions were determined as TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A (n = 80) and located in the superficial femoral artery (n = 91). There were 19 total occlusions (mean length, 41.3 mm) and 80 stenoses (mean length, 37.5 mm). Technical success was achieved in 96 patients, and clinical success was obtained in 95. Target lesion revascularization, which equalled target vessel revascularization, was 19% at 6 months and rose to 33% at 12 months. Primary patency was 68% at 6 months and 58% at 12 months. Secondary patency was 85% at 6 months and 86% at 12 months. After 12 months, two patients had undergone an amputation.

CONCLUSIONS: The 1-year follow-up results of the REMEDY stent do not meet current standards set by nitinol stents. Given the significant issues concerning bioresorbable stents in femoropopliteal arteries, their use outside clinical trials should be withheld until improvements are made and better data are available.