Current status and future perspectives of bioresorbable stents in peripheral arterial disease.

BACKGROUND: Endovascular treatment of peripheral arterial disease (PAD) still yields unsatisfactory patency rates. Recent new developments include the use of bioresorbable stents. The objective of this study was to provide an overview of currently available data on the use of bioresorbable stents in lower limb PAD and to summarize the needs for future research focus.

METHODS: A systematic search in the databases of MEDLINE, Embase, and the Cochrane Library was performed. Studies using predefined inclusion and exclusion criteria were included and critically appraised by two independent reviewers. Inclusion criteria were (1) original data on (2) bioresorbable stents in (3) lower limb arteries including the iliac tract. Primary end points were safety and feasibility of bioresorbable stents, including 30-day adverse events. Secondary end points included radial force, bioresorption process, long-term primary and secondary patency, and clinical outcomes, such as amputation rate, Rutherford category, and ankle-brachial index improvement.

RESULTS: Seven published studies with a total of 316 patients were included, and five conference abstracts including 272 patients were assessed. Median follow-up time was 12 months. Overall technical success rate was 99% (range, 95.0%-100%). The 30-day adverse event rates were reported in 5.0% of patients (range, 0%-13.3%); these included one death, two major amputations, and seven reinterventions. Mean primary patency rate was 61.6% in the femoral arteries (range, 32.1%-80.0%) after 6 to 12 months compared with 50.3% in below-the-knee lesions (range, 31.8%-92.9%). Secondary patency rates were 91.5% (range, 84%-97.1%) and 72.1% (range, 62.9%-100%), respectively. The 1-year amputation rate was 3.0% in the whole group (range, 0%-12.4%).

CONCLUSIONS: Experience with the use of bioresorbable stents in PAD is still limited and is investigated only in small studies. The use of bioresorbable stents in PAD appears to be feasible and safe. With current published results, we are unable to fully answer all of the questions about the future use of bioresorbable stents in PAD, and use should be limited to study-related cases in PAD.