{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T06:59:48Z","timestamp":1763535588629,"version":"3.40.5"},"reference-count":38,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2019,3,19]],"date-time":"2019-03-19T00:00:00Z","timestamp":1552953600000},"content-version":"vor","delay-in-days":32,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2019,2,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This prospective, patient\u2010level analysis assessed the safety and efficacy of NeoVas sirolimus\u2010eluting 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Drug\u2010eluting stent\u2010related 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\u2010eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus\u2010eluting poly\u2010<jats:sc>l<\/jats:sc>\u2010lactic acid (PLLA)\u2010based BRS whose safety and efficacy remains to be fully elucidated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patient\u2010level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n\u2009=\u2009278) and NeoVas registry (n\u2009=\u2009825) were prospectively collected, pooled, and analyzed. The primary outcome was 12\u2010month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia\u2010driven\u2010target lesion revascularization. The patient\u2010oriented composite endpoint (PoCE) of all\u2010cause death, all MI, or any revascularization was also analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 12\u2010month rate of TLF in 1,103 patients (follow\u2010up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001). Furthermore, 50 (5.4%) PoCEs and five definite\/probable ST (0.5%) were recorded.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This pooled, patient\u2010level analysis indicates that the NeoVas BRS has promising 1\u2010year efficacy and safety profiles.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28067","type":"journal-article","created":{"date-parts":[[2019,3,20]],"date-time":"2019-03-20T03:42:26Z","timestamp":1553053346000},"page":"832-838","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Safety and efficacy of the novel sirolimus\u2010eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: One\u2010year results from a prospective patient\u2010level pooled analysis of NeoVas trials"],"prefix":"10.1002","volume":"93","author":[{"given":"Kai","family":"Xu","sequence":"first","affiliation":[{"name":"General Hospital of Northern Theater Command  Shenyang 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