Objectives: The objectives of this study were to examine factors predictive of success or failure after percutaneous angioplasty (PTA) and stenting (S) of the superficial femoral artery (SFA) and to compare the results of PTA/S with a contemporary group of patients treated with femoropopliteal bypass.
Methods: A database of patients undergoing PTA and/or S of the SFA between 1986 and 2004 was maintained. Intention-to-treat analysis was performed. Patients underwent duplex scanning follow-up at 1, 3, and every 6 months after the intervention. Angiograms were reviewed in all cases to assess lesion characteristics and preprocedure and postprocedure runoff. Results were standardized to current TransAtlantic Inter-Society Consensus (TASC) and Society for Vascular Surgery (SVS) criteria. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Cox proportional hazard analyses were performed to assess factors associated with patient survival and treatment efficacy.
Results: Three hundred eighty total limbs underwent PTA/S in 329 patients (67% male, 33% female; average age, 65 years). Mean follow-up was 1.8 years from the date of initial intervention. Indications for intervention were claudication in 66%, rest pain in 16%, and tissue loss in 18%. Runoff at the tibial level was 2.1 +/- 0.8 patent vessels. Mean SVS ischemia grade was 3.1 (range, 1 to 5). TASC lesion grades were A (48%), B (18%), C (22%), and D (12%). Angioplasty alone was used in 63% of cases. Primary treatment failure (inability to cross lesion) was seen in 7% of patients. There was one periprocedural death. Primary patency rates were 86% at 3 months, 80% at 6 months, 75% at 12 months, 66% at 24 months, 60% at 36 months, 58% at 48 months, and 52% at 60 months. Assisted primary patency rates were slightly higher ( P = not significant). By Cox proportional hazards analysis, patency of PTA/S was associated with higher preoperative ankle/brachial index ( P = .016) and the performance of angioplasty only ( P = .011). Failed or occluded PTA/S was associated with TASC C ( P < .0001) and TASC D lesions ( P < .0001). Patient death was associated with the presence of congestive heart failure ( P = .003). Subgroup analysis revealed that primary patency rates are highly dependent on lesion type (A > B > C > D, P < .0001). PTA/S patency for TASC A and B lesions compared favorably to prosthetic and venous femoropopliteal bypass. Surgical bypass was superior to PTA/S for TASC C and D lesions.
Conclusions: PTA and stenting of the SFA can be performed safely with excellent procedural success rates. Improved patency of these interventions was seen with increased ankle/brachial index and the performance of angioplasty only. Worse patency was seen with TASC C and TASC D lesions. Patency rates were strongly dependent on lesion type, and the results of angioplasty and stenting compared favorably with surgical bypass for TASC A and B lesions.