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

Catheter Cardiovasc Interv. 2003 Oct;60(2):172-8; discussion 179. doi: 10.1002/ccd.10636.

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.

Publication types

  • Comparative Study
  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary
  • Anti-Inflammatory Agents / therapeutic use*
  • Belgium / epidemiology
  • Blood Vessel Prosthesis Implantation
  • Coated Materials, Biocompatible / therapeutic use*
  • Coronary Angiography
  • Coronary Restenosis / diagnosis
  • Coronary Restenosis / mortality
  • Coronary Restenosis / therapy*
  • Dexamethasone / therapeutic use*
  • Equipment Design
  • Equipment Safety
  • Female
  • Follow-Up Studies
  • Glucocorticoids / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Myocardial Ischemia / diagnosis
  • Myocardial Ischemia / mortality
  • Myocardial Ischemia / therapy
  • Pilot Projects
  • Postoperative Complications / etiology
  • Postoperative Complications / mortality
  • Postoperative Complications / therapy
  • Reoperation
  • Stents*
  • Survival Analysis
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Coated Materials, Biocompatible
  • Glucocorticoids
  • Dexamethasone