Five-Year Outcomes of the SuperB Trial: A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass.

Abstract

This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status. The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking. Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses. At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups. Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions. This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.