Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial
| Autor: | Richard R. Saxon, Jeanine M. Coffman, Eileen Natuzzi, Donald J. Ponec, Justin M. Gooding |
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| Rok vydání: | 2003 |
| Předmět: |
Male
medicine.medical_specialty Percutaneous medicine.medical_treatment Arterial Occlusive Diseases Single Center Ischemia Angioplasty medicine.artery Medicine Humans Radiology Nuclear Medicine and imaging Popliteal Artery Embolization Prospective Studies Polytetrafluoroethylene Vascular Patency Aged business.industry Stent Thrombolysis Intermittent Claudication Popliteal artery Surgery Blood Vessel Prosthesis Femoral Artery Treatment Outcome Female Stents medicine.symptom Cardiology and Cardiovascular Medicine business Claudication Angioplasty Balloon Follow-Up Studies |
| Zdroj: | Journal of vascular and interventional radiology : JVIR. 14(3) |
| ISSN: | 1051-0443 |
| Popis: | PURPOSE To 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 METHODS Twenty-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. RESULTS Technical 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. CONCLUSION This 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. |
| Databáze: | OpenAIRE |
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