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Study of antirestenosis with the BiodivYsio dexamethasone‐eluting stent (STRIDE): A first‐in‐human multicenter pilot trial
Author(s) -
Liu Xiaoshun,
Huang Yanming,
Hanet Claude,
Vandormael Michel,
Legrand Victor,
Dens Joseph,
Vandenbossche Jean Luc,
Missault Luc,
Vrints Christiaan,
De Scheerder Ivan
Publication year - 2003
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.10636
Subject(s) - medicine , stent , restenosis , mace , neointimal hyperplasia , stenosis , surgery , multicenter study , unstable angina , cardiology , myocardial infarction , randomized controlled trial , conventional pci
The aim of this multicenter pilot study was to evaluate the acute safety and efficacy of the dexamethasone‐eluting stent (0.5 μg/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 μg/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. Catheter Cardiovasc Interv 2003;60:172–178. © 2003 Wiley‐Liss, Inc.