Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial.
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.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001530:Belgium / Q000453:epidemiology; D019917:Blood Vessel Prosthesis Implantation; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003907:Dexamethasone / Q000627:therapeutic use*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D010865:Pilot Projects; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality / Q000628:therapy; D012086:Reoperation; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D020099:Coated Materials, Biocompatible; D005938:Glucocorticoids; D003907:Dexamethasone