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

医学 经皮冠状动脉介入治疗 心肌梗塞 依维莫司 靶病变 内科学 支架 冠状动脉疾病 临床终点 西罗莫司 随机对照试验 外科 血运重建 心脏病学 药物洗脱支架
作者
Kai Xu,Guosheng Fu,Bo Xu,Yujie Zhou,Xi Su,Huiliang Liu,Zheng Zhang,Bo Yu,Xiaozeng Wang,Yaling Han
出处
期刊:Catheterization and Cardiovascular Interventions [Wiley]
卷期号:93 (S1): 832-838 被引量:16
标识
DOI:10.1002/ccd.28067
摘要

Abstract 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 < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded. Conclusions This pooled, patient‐level analysis indicates that the NeoVas BRS has promising 1‐year efficacy and safety profiles.
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