Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.
Catheter Cardiovasc Interv
; 103(1): 61-67, 2024 01.
Article
in En
| MEDLINE
| ID: mdl-38098249
ABSTRACT
INTRODUCTION:
The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease.METHODS:
A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE).RESULTS:
A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively.CONCLUSION:
The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Coronary Artery Disease
/
Drug-Eluting Stents
/
Percutaneous Coronary Intervention
Limits:
Humans
Language:
En
Journal:
Catheter Cardiovasc Interv
Journal subject:
CARDIOLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Israel