S.M.A.R.T. self-expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery (STROLL): 1-year outcomes
| Autor: | Andrew Feiring, Robert Hibbard, David B. Jessup, Yazan Khatib, William Bachinsky, Michael R. Jaff, Roberto Patarca, Hans-Peter Stoll, William A. Gray, Jeffrey Tauth, Bruce H. Gray, Ernesto Rivera, Joseph M. Massaro, Marco Cioppi |
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| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Hemodynamics Constriction Pathologic Constriction Lesion Peripheral Arterial Disease Restenosis Diabetes mellitus medicine.artery medicine Alloys Humans Radiology Nuclear Medicine and imaging Ultrasonography Interventional Aged business.industry Ultrasound Stent medicine.disease Atherosclerosis Popliteal artery Surgery Femoral Artery Treatment Outcome Female Stents medicine.symptom Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Journal of vascular and interventional radiology : JVIR. 26(1) |
| ISSN: | 1535-7732 |
| Popis: | Purpose To assess safety and efficacy of the S.M.A.R.T. Vascular Stent System (Cordis Corp, Fremont, California) in obstructive superficial femoral artery (SFA) disease. Materials and Methods The single-arm, multicenter STROLL study (S.M.A.R.T. Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) included 250 patients (250 lesions in SFA or proximal popliteal artery). The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization (TLR) at 12 months. Results Mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions). The 30-day freedom from major adverse events (death, index limb amputation, clinically driven TLR) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4–0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81.0% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3–4 was reduced from 54.2% at baseline to 8.0% at 12 months. Four patients (2.0%) experienced single-stent strut fracture (type I) at 1 year, without associated loss of stent patency. Conclusions The S.M.A.R.T. Vascular Stent System proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease, based on 1-year vessel patency and associated hemodynamic and clinical improvements. |
| Databáze: | OpenAIRE |
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