Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38â
mm prospective trial.
Coron Artery Dis
; 34(6): 410-414, 2023 09 01.
Article
em En
| MEDLINE
| ID: mdl-37471280
ABSTRACT
BACKGROUND:
The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38â mm RES in long coronary lesions.METHODS:
A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30â days, 6â months, and 1â year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75â mm to ≤4.25â mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization.RESULTS:
A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4â mmâ ±â 8.3, reference vessel diameter 2.88â mmâ ±â 0.45, minimal lumen diameter 0.80â mmâ ±â 0.41, and percent diameter stenosis 72.6%â ±â 13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1â year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval (84-99%).CONCLUSION:
Percutaneous coronary intervention (PCI) of long lesions with a 38â mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions. (ClinicalTrials.gov NCT03702608).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doença da Artéria Coronariana
/
Stents Farmacológicos
/
Intervenção Coronária Percutânea
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
Limite:
Humans
Idioma:
En
Revista:
Coron Artery Dis
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Israel