One-year outcomes with the Alex Plus drug-eluting coronary stent in routine clinical practice: the RESALP (r-EPIC 01) registry

Introduction and objectives:The Alex Plus stent is a cobalt-chromium sirolimus-eluting stent with a biodegradable polymer for which postmarketing clinical data remain limited.This study aimed to evaluate the 1-year safety and clinical efficacy of this Alex Plus stent in routine clinical practice.Methods: This prospective, multicenter, observational registry was conducted in Spain.Eligible patients were referred for percutaneous coronary intervention (PCI) due to stable angina, acute coronary syndrome with or without ST-segment elevation, or silent ischemia.Implantation of at least 1 Alex Plus stent was required, although the use of additional devices was permitted according to routine clinical practice.The primary endpoints were target lesion revascularization (TLR) of of lesions treated with the study stent and target vessel failure (TVF) at 1 year.Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE).Results: 589 patients were enrolled; 547 (92.9%) were analyzed.Mean age was 65.7 ± 11.1 years.22.5% were women.Overall, 1006 stents were implanted, including 722 Alex Plus (71.8%).Acute coronary syndrome was the indication in 67%.In-hospital MACCE was 1.65%.At one-year, target lesion revascularization and target vessel failure were 3.1% and 3.5%, respectively; stent thrombosis occurred in 0.7%.Mortality was 4%, myocardial infarction 2%, stroke 1.5%, and overall MACCE 12.1%.Renal dysfunction strongly predicted mortality and MACCE, while disease extent and number of treated vessels and stents were associated with adverse events.Conclusions: In real-world clinical practice, the Alex Plus stent demonstrated low rates of revascularization and thrombosis at one-year, with a safety and efficacy profile comparable to that of other contemporary DES.