OBJECTIVE: Techniques for surgical repair of Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions of the superficial femoral artery (SFA) are supragenicular bypass grafting or the less invasive remote endarterectomy (RSFAE). This trial compares the patency rates of both techniques. DESIGN: Randomized, multicenter trial. MATERIALS AND METHODS: 116 patients were randomized to RSFAE (n=61) and supragenicular bypass surgery (n=55). Indications for surgery were claudication (n=77), rest pain (n=21), or tissue loss (n=18). RESULTS:Median hospital stay was 4 days in the RSFAE group compared with 6 days in the bypass group (p=0.004). Primary patency after 1-year follow-up was 61% for RSFAE and 73% for bypass (p=0.094). Secondary patency was 79% for both groups. Subdividing between venous (n=25) and prosthetic grafts (n=30) shows a primary patency of 89% and 63% respectively at 1-year follow-up (p=0.086). CONCLUSION:RSFAE is a minimally invasive adjunct in the treatment of TASC C and D lesions of the SFA, with shorter admittance and a comparable secondary patency rate to bypass. The venous bypass is superior to both RSFAE and PTFE bypass surgery, but only 45% of patients had a sufficient saphenous vein available. This study is registered with ClinicalTrials.gov, number NCT00566436.
RCT Entities:
OBJECTIVE: Techniques for surgical repair of Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions of the superficial femoral artery (SFA) are supragenicular bypass grafting or the less invasive remote endarterectomy (RSFAE). This trial compares the patency rates of both techniques. DESIGN: Randomized, multicenter trial. MATERIALS AND METHODS: 116 patients were randomized to RSFAE (n=61) and supragenicular bypass surgery (n=55). Indications for surgery were claudication (n=77), rest pain (n=21), or tissue loss (n=18). RESULTS: Median hospital stay was 4 days in the RSFAE group compared with 6 days in the bypass group (p=0.004). Primary patency after 1-year follow-up was 61% for RSFAE and 73% for bypass (p=0.094). Secondary patency was 79% for both groups. Subdividing between venous (n=25) and prosthetic grafts (n=30) shows a primary patency of 89% and 63% respectively at 1-year follow-up (p=0.086). CONCLUSION: RSFAE is a minimally invasive adjunct in the treatment of TASC C and D lesions of the SFA, with shorter admittance and a comparable secondary patency rate to bypass. The venous bypass is superior to both RSFAE and PTFE bypass surgery, but only 45% of patients had a sufficient saphenous vein available. This study is registered with ClinicalTrials.gov, number NCT00566436.
Authors: George A Antoniou; George S Georgiadis; Stavros A Antoniou; Ragai R Makar; Jonathan D Smout; Francesco Torella Journal: Cochrane Database Syst Rev Date: 2017-04-03
Authors: Bethany G Wardle; Graeme K Ambler; Rami W Radwan; Robert J Hinchliffe; Christopher P Twine Journal: Cochrane Database Syst Rev Date: 2020-09-29