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A Prospective Randomized Comparison of Percutaneous ePTFE/Nitinol Self Expanding Stent Grafts vs. Prosthetic Femoral – Popliteal Bypass in the Treatment of Superficial Femoral Artery Occlusive Disease with Twenty-Four Month Follow-up

Karen McQuade, Stephen Hohmann, Brian Theune, Gregory Pearl, Dennis Gable.
Baylor University Medical Center, Dallas, Texas.

OBJECTIVES: A randomized prospective study comparing the percutaneous treatment of superficial femoral artery (SFA) occlusive disease with an 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 eighty-six patients with SFA artery occlusive disease were identified from March 2004 to May 2005. Patient symptoms included claudication and/or limb threatening ischemia with or without tissue loss. Patients were prospectively randomized 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. TASC C and D lesions were the most common lesions treated (82% of patients in the surgical group; 84% of patients in the stent graft group). Mean total length of the treated arterial segment in the stent graft group was 25.6 cm (SD±15 cm). 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: Patients were followed for 24 months. Procedural complications, primary and secondary patencies as well as cost analysis for the initial procedures were evaluated. The stent graft group demonstrated a primary patency of 82%, 73% and 62% with a secondary patency of 86%, 84% and 73% at 6, 12 and 24 months respectively. The surgical femoral-popliteal group demonstrated a primary patency of 88%, 79% and 65% with a secondary patency of 90%, 83% and 75% at 6, 12 and 24 months respectively. No statistical difference was found between the two groups with respect to primary (p>0.05) or secondary patency (p>0.05). There were 16 re-interventions in the stent-graft group and 15 re-interventions in the surgical group.

CONCLUSIONS: Management of SFA occlusive disease with percutaneous stent grafts exhibits equivalent primary patency at 24 month follow-up when compared to conventional femoral popliteal arterial bypass with prosthetic conduit. This treatment method may offer an alternative to treatment of the SFA segment for revascularization when prosthetic bypass is being considered.
AUTHOR DISCLOSURES: K. McQuade, None; S. Hohmann, None; B. Theune, None; G. Pearl , None; D. Gable, Gore.