• Richard R Saxon, Jeanine M Coffman, Justin M Gooding, Eileen Natuzzi, and Donald J Ponec.
• San Diego Vascular Institute, Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, 4002 Vista Way, Oceanside, California 92056, USA. rsaxonmd@nctimes.net
• J Vasc Interv Radiol. 2003 Mar 1; 14 (3): 303-11.

PurposeTo describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions.Materials And MethodsTwenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months.ResultsTechnical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87% of patients (13 of 15) in the endoprosthesis group versus 46% of patients (six of 13) in the PTA group.ConclusionThis single-center experience with placement of the Hemobahn endoprosthesis (W.L. Gore & Associates) in the SFA demonstrated a statistically significant improvement in both patency and clinical outcome compared with PTA alone.

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