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Peripheral Arterial Obstruction: Prospective Study of Treatment with a Transluminally Placed Self-expanding Stent-Graft¹

¹ From the Department of Angiography and Interventional Radiology, Universitatsklinik fur Radiodiagnostik, AKH Universitatskliniken, Wahringer Gurtel 18-20, A-1090 Vienna, Austria (J.L., M.C.); Department of Radiology, Division of Interventional Radiology, Stanford University, Palo Alto, Calif (M.D.D.); Antwerp Bloedvaten Centrum, Belgium (J.B.); Miami Cardiac and Vascular Institute, Fla (B.T.K., G.J.B.); Department of Vascular Surgery, Hopital De La Timone, Marseille, France (P.P.); W. L. Gore and Associates, Flagstaff, Ariz (R.A.S.). Received July 7, 1999; revision requested August 16; revision received November 29; accepted December 7. Financial support is listed at the end of this article. Address correspondence to J.L. (e-mail: Johannes.Lammer@univie.ac.at).

PURPOSE: To evaluate the safety and efficacy of an endoluminal prosthesis for treatment of peripheral arterial occlusive disease (PAOD).

MATERIALS AND METHODS: A self-expanding endoprosthesis with an expanded polytetrafluoroethylene tube inside a nitinol support structure was implanted in 127 patients with symptomatic PAOD in the iliac (61 limbs) and femoral arteries (80 limbs). Clinical category status, ankle-brachial index, and color duplex flow imaging results were recorded before treatment, at discharge, and at 1, 3, 6, and 12 months after treatment. Aspirin was administered throughout the study, and heparin was administered during and for 2 days after the procedure.

RESULTS: Endoprosthesis deployment was technically successful in all patients. Complications occurred in 24 of 141 procedures and included three major complications. Early thrombosis (within 30 days) occurred in one iliac and three femoral arteries. Late restenosis or reocclusion was observed in five iliac and 14 femoral arteries within the 1st year. Primary patency rates in iliac arteries were 98% ± 3% (standard error) and 91% ± 4%, respectively, at 6 and 12 months after treatment. Primary patency rates in femoral arteries were 90% ± 3% and 79% ± 5%, respectively, at 6 and 12 months. Secondary patency rates were 95% and 93% for iliac and femoral arteries, respectively, at 12 months after treatment.

CONCLUSION: The device used in this study can be implanted without additional risks to the patient and provided encouraging patency rates up to 1 year.

Index terms: Arteriosclerosis, 92.721 , 98.721 • Arteries, peripheral • Arteries, restenosis, 92.44, 98.44 • Arteries, stenosis or obstruction, 92.44, 92.721, 98.44, 98.721 • Arteries, grafts and prostheses, 92.1286, 98.1286

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