Abstract
The aim of this multicenter pilot study was to evaluate the acute safety and efficacy of the dexamethasone-eluting stent (0.5 microg/mm(2) of stent) implanted in patients with de novo single-vessel disease. This study included 71 patients, 42% of whom had unstable angina pectoris. An appropriately sized BiodivYsio Matrix Lo stent loaded with a total dexamethasone dose of 0.5 microg/mm(2) of stent was used. Technical device success rate was 95%. Six-month MACE occurred in two patients (3.3%). Binary restenosis rate was 13.3%. Late loss was 0.45. Late loss and percent diameter stenosis were lower in the unstable angina pectoris patients compared to the stable patients (0.32 +/- 0.39 vs. 0.60 +/- 0.55 mm, P < 0.07, and 26.86 +/- 14 vs. 38.40 +/- 16%, P < 0.02). This study demonstrated the feasibility and safety of the implantation of a dexamethasone-eluting stent and its effect on in-stent neointimal hyperplasia.
Copyright 2003 Wiley-Liss, Inc.
Publication types
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Comparative Study
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Evaluation Study
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Multicenter Study
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Angioplasty, Balloon, Coronary
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Anti-Inflammatory Agents / therapeutic use*
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Belgium / epidemiology
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Blood Vessel Prosthesis Implantation
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Coated Materials, Biocompatible / therapeutic use*
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Coronary Angiography
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Coronary Restenosis / diagnosis
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Coronary Restenosis / mortality
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Coronary Restenosis / therapy*
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Dexamethasone / therapeutic use*
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Equipment Design
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Equipment Safety
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Female
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Follow-Up Studies
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Glucocorticoids / therapeutic use*
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Humans
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Male
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Middle Aged
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Myocardial Ischemia / diagnosis
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Myocardial Ischemia / mortality
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Myocardial Ischemia / therapy
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Pilot Projects
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Postoperative Complications / etiology
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Postoperative Complications / mortality
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Postoperative Complications / therapy
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Reoperation
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Stents*
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Survival Analysis
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Time Factors
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Treatment Outcome
Substances
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Anti-Inflammatory Agents
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Coated Materials, Biocompatible
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Glucocorticoids
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Dexamethasone