Three‐year clinical outcomes of the novel sirolimus‐eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: A prospective patient‐level pooled analysis of NeoVas trials

Abstract Objectives We aimed to evaluate the long‐term outcomes of the novel NeoVas sirolimus‐eluting bioresorbable scaffold (BRS) for the treatment of de novo coronary artery disease. Background The long‐term safety and efficacy of the novel NeoVas BRS are still needed to be elucidated. Methods A total of 1103 patients with de novo native coronary lesions for coronary stenting were enrolled. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death (CD), target vessel myocardial infarction (TV‐MI), or ischemia‐driven‐target lesion revascularization (ID‐TLR). Results A three‐year clinical follow‐up period was available for 1,091 (98.9%) patients. The cumulative TLF rate was 7.2% with 0.8% for CD, 2.6% for TV‐MI, and 5.1% for ID‐TLR. Additionally, 128 (11.8%) patient‐oriented composite endpoint and 11 definite/probable stent thromboses (1.0%) were recorded. Conclusions The extended outcomes of the NeoVas objective performance criterion trial demonstrated a promising 3‐year efficacy and safety of the NeoVas BRS in low‐risk patients with low complexity in terms of lesions and comorbidities.