Percutaneous coronary intervention with ridaforolimus eluting‐stents in small vessel coronary artery disease

Abstract

AbstractIntroductionThe ridaforolimus‐eluting stent (RES) system uses a novel cobalt alloy‐based coronary stent with a durable elastomeric polymer eluting ridaforolimus.Aim of studyTo assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease.MethodsA 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).ResultsA 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.ConclusionThe 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.