Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease.

Background: A randomized prospective study comparing the treatment of superficial femoral artery occlusive disease percutaneously with an expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent graft (stent-graft) vs surgical femoral to above knee popliteal artery bypass with synthetic graft material.

Methods: One hundred limbs in 86 patients with superficial femoral artery occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included both claudication and limb threatening ischemia with or without tissue loss. The TransAtlantic InterSociety Consensus (TASC) II A (N = 18), B (N = 56), C (N = 11), and D (N = 15) lesions were included. Patients were randomized prospectively into one of two treatment groups; a percutaneous treatment group (group A; N = 50) with angioplasty and placement of one or more stent-grafts or a surgical treatment group (group B; N = 50) with a femoral to above knee popliteal artery bypass using synthetic conduit (Dacron graft or ePTFE). Patients were followed for a total of 24 months. Follow-up evaluation included clinical assessment and physical examination, ankle-brachial indices (ABI), and color flow duplex sonography at 3, 6, 9, 12, 18, and 24 months.

Results: The mean total lesion length of the treated arterial segment in the stent-graft group was 25.6 cm (SD +/- 15 cm). The stent-graft group demonstrated a primary patency of 81%, 72%, and 63% with a secondary patency of 86%, 83%, and 74% at 6, 12, and 24 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 84%, 77%, and 64% with a secondary patency of 89%, 86%, and 76% at 6, 12, and 24 months, respectively. No statistical difference was found between the two groups with respect to primary (P = .716) or secondary patency (P = .695). Grouping of less severe (TASC II A/B) vs more severe (TASC II C/D) lesions demonstrated patency at 24 months for the femoral-popliteal arm of 63% and 67%, respectively while that of the stent-graft arm was 64% and 47%, respectively. Secondary patency was 76% in both TASC classifications for the femoral-popliteal arm with 78% and 47% patency found respectively in the stent-graft group. These resulted in no significant difference for primary (P = .978) or secondary (P = .653) patency overall, although there is a trend for decreased patency with higher TASC II lesions.

Conclusion: Management of superficial femoral artery occlusive disease with percutaneous stent-grafts exhibits similar primary patency at 24-month follow-up when compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. This treatment method may offer an alternative to treatment of the superficial femoral artery segment for revascularization when prosthetic bypass is being considered or when autologous conduit is unavailable.