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.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
wsj发布了新的文献求助10
2秒前
ZONG发布了新的文献求助20
2秒前
wuy发布了新的文献求助10
4秒前
5秒前
6秒前
6秒前
Jun关闭了Jun文献求助
6秒前
星星发布了新的文献求助10
7秒前
9秒前
射天狼发布了新的文献求助10
9秒前
9秒前
9秒前
zebra8848完成签到,获得积分10
9秒前
10秒前
深情安青应助wsj采纳,获得10
10秒前
10秒前
sxy发布了新的文献求助10
11秒前
蔡从安发布了新的文献求助10
12秒前
13秒前
柔弱云朵完成签到,获得积分10
14秒前
14秒前
14秒前
xxddw发布了新的文献求助10
14秒前
Owen应助小晓采纳,获得10
15秒前
16秒前
16秒前
16秒前
23秒前
23秒前
量子星尘发布了新的文献求助10
23秒前
23秒前
肖雪依完成签到,获得积分10
24秒前
26秒前
Tink完成签到,获得积分0
26秒前
麦子发布了新的文献求助10
29秒前
星辰大海应助自信鑫鹏采纳,获得10
30秒前
铮铮完成签到,获得积分10
30秒前
Leeie03发布了新的文献求助10
30秒前
32秒前
思源应助wuy采纳,获得10
34秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989444
求助须知:如何正确求助?哪些是违规求助? 3531531
关于积分的说明 11254250
捐赠科研通 3270191
什么是DOI,文献DOI怎么找? 1804901
邀请新用户注册赠送积分活动 882105
科研通“疑难数据库(出版商)”最低求助积分说明 809174