Safety and efficacy of the novel sirolimus‐eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: One‐year results from a prospective patient‐level pooled analysis of NeoVas trials

作者：Kai Xu, Guosheng Fu, Bo Xu, Yujie Zhou, Xi Su, Huiliang Liu, Zheng Zhang, Bo Yu, Xiaozeng Wang, Yaling Han, on behalf of the NeoVas OPC Investigators · 发表于：Catheterization and Cardiovascular Interventions · 年份：2019 · DOI：10.1002/ccd.28067 · 被引用次数：18 · 研究领域：Coronary Interventions and Diagnostics、Cardiac and Coronary Surgery Techniques、Angiogenesis and VEGF in Cancer

OBJECTIVES: This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial. BACKGROUND: Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated. METHODS: Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed. RESULTS: The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P ...