title: Multicenter registry to evaluate the efficacy of the NIROYAL stent in de novo or restenotic coronary stenosis.
abstract: The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm. Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5+/-10.8% to 2.7+/- 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p<0.05) predictive factors for MACE. The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.
authors.affiliation: Villa Maria Cecilia, Cardiology Department, Via Corriera 1, I-48010 Cotignola, Ravenna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Cremonesi
authors.forename: E
authors.initials: E
authors.lastname: Benit
authors.forename: M
authors.initials: M
authors.lastname: Carlier
authors.forename: A
authors.initials: A
authors.lastname: Colombo
authors.forename: R
authors.initials: R
authors.lastname: Piva
authors.forename: P
authors.initials: P
authors.lastname: Probst
authors.forename: A
authors.initials: A
authors.lastname: Wirtzfeld
authors.forename: C
authors.initials: C
authors.lastname: Pico-Bourdonnec
authors.forename: T
authors.initials: T
authors.lastname: Corcos
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000175:diagnosis / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D003251:Constriction, Pathologic / Q000628:therapy; D003327:Coronary Disease / Q000175:diagnosis / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006046:Gold; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D011336:Probability; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D015607:Stents; D016896:Treatment Outcome
chemical_list: D006046:Gold