Paul J L Ong, Shing Fung Chui, Frankie Chor-Cheung Tam, Quang Tuan Nguyen, Cheng-Ting Tsai, Woong Chol Kang, Amin Arif Nuruddin, Ramesh Singh, Chunhakasem Chotinaiwattarakul, Michael Lee
{"title":"治疗亚洲患者急性ST段抬高型心肌梗死的无聚合物生物利莫司涂层支架。","authors":"Paul J L Ong, Shing Fung Chui, Frankie Chor-Cheung Tam, Quang Tuan Nguyen, Cheng-Ting Tsai, Woong Chol Kang, Amin Arif Nuruddin, Ramesh Singh, Chunhakasem Chotinaiwattarakul, Michael Lee","doi":"10.1002/ccd.31263","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment-elevation myocardial infarction (STEMI) have a high thrombotic burden and often have a high bleeding risk (HBR). Asian patients have different patterns of thrombotic and bleeding risk from other populations which may be particularly relevant in the setting of PPCI for STEMI.</p><p><strong>Objectives: </strong>To assess the safety and efficacy of the polymer free biolimus coated coronary stent (PF-BCS, BioFreedom<sup>TM</sup>, Biosensors International) in Asian STEMI patients.</p><p><strong>Methods: </strong>Patients with acute STEMI who received at least one PF-BCS were invited to participate after their index procedure. Follow-up was performed at 1, 4, and 12 months. The primary endpoint was the rate of target lesion failure (TLF) at 1 year. A performance goal was derived from the biolimus eluting stent arm of the COMFORTABLE AMI study which was the only prior dedicated study of biolimus eluting stents in patients with STEMI.</p><p><strong>Results: </strong>A total of 914 patients with STEMI were enrolled. Mean patient age was 60 ± 13 years, diabetes was present in 23.2% and 43% were active smokers. According to the ARC definition, 12.4% of the patients were HBR. TLF rate was 2.54% [95% CI: 1.52-3.56], p-value for non-inferiority <0.0001, p-value for superiority = 0.0004). The rate of definite/probable stent thrombosis was 0.44% [95% CI: 0.16-1.16]. There was a trend toward more BARC 3 to 5 bleeding in ARC-HBR patients (3.69% vs 1.46%, HR = 2.74, [95% CI: 0.87-8.62], p = 0.07).</p><p><strong>Conclusions: </strong>In Asian patients undergoing PPCI for STEMI and treated with variable durations of DAPT, the use of a PF-BCS was associated with low rates of TLF and stent thrombosis (NCT03609346).</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients.\",\"authors\":\"Paul J L Ong, Shing Fung Chui, Frankie Chor-Cheung Tam, Quang Tuan Nguyen, Cheng-Ting Tsai, Woong Chol Kang, Amin Arif Nuruddin, Ramesh Singh, Chunhakasem Chotinaiwattarakul, Michael Lee\",\"doi\":\"10.1002/ccd.31263\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment-elevation myocardial infarction (STEMI) have a high thrombotic burden and often have a high bleeding risk (HBR). Asian patients have different patterns of thrombotic and bleeding risk from other populations which may be particularly relevant in the setting of PPCI for STEMI.</p><p><strong>Objectives: </strong>To assess the safety and efficacy of the polymer free biolimus coated coronary stent (PF-BCS, BioFreedom<sup>TM</sup>, Biosensors International) in Asian STEMI patients.</p><p><strong>Methods: </strong>Patients with acute STEMI who received at least one PF-BCS were invited to participate after their index procedure. Follow-up was performed at 1, 4, and 12 months. The primary endpoint was the rate of target lesion failure (TLF) at 1 year. A performance goal was derived from the biolimus eluting stent arm of the COMFORTABLE AMI study which was the only prior dedicated study of biolimus eluting stents in patients with STEMI.</p><p><strong>Results: </strong>A total of 914 patients with STEMI were enrolled. Mean patient age was 60 ± 13 years, diabetes was present in 23.2% and 43% were active smokers. According to the ARC definition, 12.4% of the patients were HBR. TLF rate was 2.54% [95% CI: 1.52-3.56], p-value for non-inferiority <0.0001, p-value for superiority = 0.0004). The rate of definite/probable stent thrombosis was 0.44% [95% CI: 0.16-1.16]. There was a trend toward more BARC 3 to 5 bleeding in ARC-HBR patients (3.69% vs 1.46%, HR = 2.74, [95% CI: 0.87-8.62], p = 0.07).</p><p><strong>Conclusions: </strong>In Asian patients undergoing PPCI for STEMI and treated with variable durations of DAPT, the use of a PF-BCS was associated with low rates of TLF and stent thrombosis (NCT03609346).</p>\",\"PeriodicalId\":9650,\"journal\":{\"name\":\"Catheterization and Cardiovascular Interventions\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-10-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Catheterization and Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ccd.31263\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ccd.31263","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients.
Background: Patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment-elevation myocardial infarction (STEMI) have a high thrombotic burden and often have a high bleeding risk (HBR). Asian patients have different patterns of thrombotic and bleeding risk from other populations which may be particularly relevant in the setting of PPCI for STEMI.
Objectives: To assess the safety and efficacy of the polymer free biolimus coated coronary stent (PF-BCS, BioFreedomTM, Biosensors International) in Asian STEMI patients.
Methods: Patients with acute STEMI who received at least one PF-BCS were invited to participate after their index procedure. Follow-up was performed at 1, 4, and 12 months. The primary endpoint was the rate of target lesion failure (TLF) at 1 year. A performance goal was derived from the biolimus eluting stent arm of the COMFORTABLE AMI study which was the only prior dedicated study of biolimus eluting stents in patients with STEMI.
Results: A total of 914 patients with STEMI were enrolled. Mean patient age was 60 ± 13 years, diabetes was present in 23.2% and 43% were active smokers. According to the ARC definition, 12.4% of the patients were HBR. TLF rate was 2.54% [95% CI: 1.52-3.56], p-value for non-inferiority <0.0001, p-value for superiority = 0.0004). The rate of definite/probable stent thrombosis was 0.44% [95% CI: 0.16-1.16]. There was a trend toward more BARC 3 to 5 bleeding in ARC-HBR patients (3.69% vs 1.46%, HR = 2.74, [95% CI: 0.87-8.62], p = 0.07).
Conclusions: In Asian patients undergoing PPCI for STEMI and treated with variable durations of DAPT, the use of a PF-BCS was associated with low rates of TLF and stent thrombosis (NCT03609346).
期刊介绍：
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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