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Study of antirestenosis with the biodivYsio dexamethasone-eluting stent (STRIDE): A first-in-human multicenter pilot trial

par Liu, Xiaoshun;Huang, Yanming;Dens, Joseph;De Scheerder, Ivan;Hanet, Claude;Vandormael, Michel;Legrand, Victor;Vandenbossche, Jean Luc ;Missault, Luc;Vrints, Christiaan Jm
Référence Catheterization and cardiovascular interventions, 60, 2, page (172-178)
Publication Publié, 2003-10

Article révisé par les pairs

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Résumé :

The aim of this multicenter pilot study was to evaluate the acute safety and efficacy of the dexamethasone-eluting stent (0.5 μg/mm2 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/mm2 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. © 2003 Wiley-Liss, Inc.