OBJECTIVE: This randomized prospective study was designed to compare the effectiveness of treating superficial femoral artery occlusive disease percutaneously with expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent grafts vs surgical femoral-to-above knee (AK) popliteal artery bypass with synthetic graft material. METHODS: From March 2004 to May 2005, 100 limbs in 86 patients with femoral-popliteal arterial occlusive disease were identified. Patients had symptoms ranging from claudication to rest pain, with or without tissue loss, and were prospectively randomized for treatment into one of two groups. The limbs were treated percutaneously with angioplasty and one or more self-expanding stent grafts (n = 50) or surgically with femoral-to-AK popliteal artery bypass using synthetic Dacron or ePTFE grafts (n = 50). The mean +/- SD total length of artery stented was 25.6 +/- 15 cm. Follow-up evaluation with ankle-brachial indices and color flow duplex sonography imaging were performed at 3, 6, 9, and 12 months after treatment. RESULTS: Patients were monitored for a median of 18 months. No statistical difference was found in the primary patency (P = .895) or secondary patency (P = .861) between the two treatment groups. Primary patency at 3, 6, 9, and 12 months of follow-up was 84%, 82%, 75.6%, and 73.5% for the stent graft group and 90%, 81.8%, 79.7%, and 74.2% for the femoral-popliteal surgical group. Thirteen patients in the stent graft group had 14 reinterventions, and 12 reinterventions occurred in the surgical group. This resulted in secondary patency rates of 83.9% for the stent graft group and 83.7% for the surgical group at the 12-month follow-up. CONCLUSIONS: Management of femoral-popliteal arterial occlusive disease using percutaneous treatment with a stent graft is comparable with surgical revascularization with conventional femoral-to-AK popliteal artery bypass using synthetic material up to 12 months. Longer-term follow-up would be helpful in determining ongoing efficacy.
RCT Entities:
OBJECTIVE: This randomized prospective study was designed to compare the effectiveness of treating superficial femoral artery occlusive disease percutaneously with expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent grafts vs surgical femoral-to-above knee (AK) popliteal artery bypass with synthetic graft material. METHODS: From March 2004 to May 2005, 100 limbs in 86 patients with femoral-popliteal arterial occlusive disease were identified. Patients had symptoms ranging from claudication to rest pain, with or without tissue loss, and were prospectively randomized for treatment into one of two groups. The limbs were treated percutaneously with angioplasty and one or more self-expanding stent grafts (n = 50) or surgically with femoral-to-AK popliteal artery bypass using synthetic Dacron or ePTFE grafts (n = 50). The mean +/- SD total length of artery stented was 25.6 +/- 15 cm. Follow-up evaluation with ankle-brachial indices and color flow duplex sonography imaging were performed at 3, 6, 9, and 12 months after treatment. RESULTS:Patients were monitored for a median of 18 months. No statistical difference was found in the primary patency (P = .895) or secondary patency (P = .861) between the two treatment groups. Primary patency at 3, 6, 9, and 12 months of follow-up was 84%, 82%, 75.6%, and 73.5% for the stent graft group and 90%, 81.8%, 79.7%, and 74.2% for the femoral-popliteal surgical group. Thirteen patients in the stent graft group had 14 reinterventions, and 12 reinterventions occurred in the surgical group. This resulted in secondary patency rates of 83.9% for the stent graft group and 83.7% for the surgical group at the 12-month follow-up. CONCLUSIONS: Management of femoral-popliteal arterial occlusive disease using percutaneous treatment with a stent graft is comparable with surgical revascularization with conventional femoral-to-AK popliteal artery bypass using synthetic material up to 12 months. Longer-term follow-up would be helpful in determining ongoing efficacy.
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