期刊
JACC-CARDIOVASCULAR INTERVENTIONS
卷 10, 期 2, 页码 147-156出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2016.10.020
关键词
drug-eluting stent(s); drug-filled stent(s); percutaneous coronary intervention; polymer-free stent
资金
- Medtronic (Santa Rosa, California)
- St. Jude Medical
- Abbott Vascular
- Boston Scientific
- Abiomed
- Eli Lilly
- GlaxoSmithKline
- HeartFlow
- Biosensors
- Biotronik
- Reva Corporation
- Medtronic
OBJECTIVES This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease. BACKGROUND Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. METHODS The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length # 27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data. RESULTS Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 +/- 0.28 mm for DFS and 0.36 +/- 0.52 mm for Resolute (pnoninferiority < 0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred. CONCLUSIONS At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348) (C) 2017 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
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