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

• Published in: Catheterization and cardiovascular interventions Vol. 60; no. 2; pp. 172 - 178
• Main Authors: Liu, Xiaoshun, Huang, Yanming, Hanet, Claude, Vandormael, Michel, Legrand, Victor, Dens, Joseph, Vandenbossche, Jean Luc, Missault, Luc, Vrints, Christiaan, De Scheerder, Ivan
• Format: Journal Article Web Resource
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.10.2003; Wiley-Liss; Wiley Liss, Inc
• Subjects: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Anti-Inflammatory Agents - therapeutic use; Belgium - epidemiology; Biological and medical sciences; Blood Vessel Prosthesis Implantation; Cardiovascular & respiratory systems; Coated Materials, Biocompatible - therapeutic use; Coronary Angiography; Coronary Restenosis - diagnosis; Coronary Restenosis - mortality; Coronary Restenosis - therapy; dexamethasone; Dexamethasone - therapeutic use; Diseases of the cardiovascular system; drug-eluting stent; Equipment Design; Equipment Safety; Female; Follow-Up Studies; Glucocorticoids - therapeutic use; Human health sciences; Humans; Male; Medical sciences; Middle Aged; Myocardial Ischemia - diagnosis; Myocardial Ischemia - mortality; Myocardial Ischemia - therapy; Pilot Projects; Postoperative Complications - etiology; Postoperative Complications - mortality; Postoperative Complications - therapy; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Reoperation; Sciences de la santé humaine; Stents; Survival Analysis; Systèmes cardiovasculaire & respiratoire; Time Factors; Treatment Outcome; Belgium; Human; Restenosis; Corticosteroid; Endoprosthesis; Dexamethasone; Prognosis; Treatment; drug-eluting stent; Coronary artery; Instrumentation therapy; Instrumental dilatation; Technique
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.10636

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. Catheter Cardiovasc Interv 2003;60:172–178. © 2003 Wiley‐Liss, Inc.