Endovascular treatment of long lesions of the superficial femoral artery: results from a multicenter registry of a spiral, covered polytetrafluoroethylene stent.
OBJECTIVE: Information on outcome of patients with long superficial femoral artery (SFA) obstruction undergoing endovascular treatment is scarce. The present study reports results from a prospective multicenter registry designed to evaluate the safety, effectiveness, and patency of the aSpire self-expanding polytetrafluoroethylene covered stent (Vascular Architects Inc, San Jose, Calif) in patients with femoropopliteal occlusive disease. METHOD: The aSpire Registry included 150 patients (166 limbs) enrolled in 16 centers during a 28-month period (2003 to 2005) for medium/long (>3 cm) occlusion (n = 115) or stenosis (n = 51) of the SFA (n = 51) or of the proximal popliteal (n = 115) arteries. Procedures were performed for intermittent claudication in 92, for rest pain in 33, and for limb savage in 41. The mean length of arterial segment covered was 107.35 +/- 73.7 mm. Indications for treatment included 44 type B1, 57 type B2, 47 type C1, and 18 type D lesions according to TransAtlantic Inter-Society Consensus classification. Clinical and ultrasound evaluation was performed at discharge and at 1, 6, 12 months, and yearly thereafter. Mean follow-up was 13 months (range, 1 to 36). Primary end points were immediate technical success (vessel recanalization with residual stenosis < or =30%) and stent patency. RESULTS: Initial technical success was obtained in 162 (97.6%) of 166 procedures. More than one stent was applied in 48 procedures, for a total of 214 stents. No periprocedural deaths occurred. Procedure-related complications occurred in 22 of 166 procedures, including 6 peripheral embolizations, 7 thromboses, 2 hemorrhages requiring revision, 1 vessel rupture, and 6 vessel dissections. Life-table estimates of primary patency at 12, 24, and 36 months were 64%, 59%, and 59%, respectively. Thirty-two reinterventions were performed during follow-up, resulting in secondary patency rates at 12, 24, and 36 months of 74.2%, 67%, and 67%, respectively. Amputation was required in six of 41 patients treated for limb salvage. At multivariate analysis, critical limb ischemia was the only significant predictor of late failure. CONCLUSION: Endovascular treatment of SFA occlusive lesions provides interesting results. Length of lesion and clinical symptoms influence negatively the patency. The aSpire covered stent showed good mid-term results, but a number of reinterventions were necessary to obtain an optimal secondary patency. Risk of patency failure was related to critical limb ischemia as an indication for the procedure. Technologic and pharmacologic improvement and longer follow-up are needed to define the indications for the aSpire stent.