Endovascular treatment of long lesions of the superficial femoral artery: Results from a multicenter registry of a spiral, covered polytetrafluoroethylene stent

• Published in: Journal of vascular surgery 2007, Vol.45 (1), p.32-39
• Main Authors: Lenti, Massimo, MD, Cieri, Enrico, MD, De Rango, Paola, MD, Pozzilli, Pietro, MD, Coscarella, Carlo, MD, Bertoglio, Carlo, MD, Troiani, Roberto, MD, Cao, Piergiorgio, MD, FRCS
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Angiography; Arterial Occlusive Diseases - diagnostic imaging; Arterial Occlusive Diseases - surgery; Biological and medical sciences; Blood and lymphatic vessels; Blood Vessel Prosthesis Implantation - instrumentation; Cardiology. Vascular system; Coated Materials, Biocompatible; Diseases of the aorta; Diseases of the cardiovascular system; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stents; Surgery; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2006.08.032

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 ≤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 isc