期刊
JACC-CARDIOVASCULAR INTERVENTIONS
卷 9, 期 1, 页码 51-64出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2015.09.008
关键词
biolimus; carrier-free; coronary artery disease; drug-coated stent(s); percutaneous coronary intervention; polymer-free
资金
- Biosensors Europe SA
- Medtronic
- Daiichi-Sankyo
- Boston Scientific
- Abbott Vascular
- Biosensors
- Elixir Medical
- Bristol-Myers Squibb/Sanofi Pharmaceuticals
- Eli Lilly
- AstraZeneca
- Medicines Company
- Lilly/Daiichi-Sankyo
- Bayer
- CSL Behring
- Covidien
- Merck
- Osprey Medical
- Regado Biosciences
- Sanofi-Aventis
- Watermark Research Partners
- Janssen Pharmaceuticals/Johnson Johnson
OBJECTIVES The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions. BACKGROUND The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland). METHODS A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD standard dose (BFD) or BFD low dose (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany. RESULTS Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported. CONCLUSIONS The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119) (J Am Coll Cardiol Intv 2016; 9:51-64) (C) 2016 by the American College of Cardiology Foundation.
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