{"title":"非瓣膜性心房颤动患者经皮左心耳关闭手术干预后直接口服抗凝剂与华法林的临床疗效及安全性比较:一项前瞻性观察研究。","authors":"Yao Yao, Qinchun Jin, Xiaochun Zhang, Qianzhou Lv","doi":"10.1186/s40360-024-00834-7","DOIUrl":null,"url":null,"abstract":"<p><p>The main objective of this study was to investigate the optimal post-left atrial appendage closure (LAAC) anticoagulation strategy, focusing on minimizing device-related thrombosis (DRT) and thromboembolism (TE) events without increasing bleeding risk. After successful LAAC, consecutive participants were treated with 45-day anticoagulants (rivaroxaban 15 mg daily, dabigatran 110 mg twice a day, and warfarin). The efficacy endpoints included DRT, TE, and hospital readmissions due to cardiac caused, while safety endpoints encompassed bleeding events, monitored over a 12-month follow-up period. The incidence of DRT was relatively lower in the rivaroxaban group compared to both the dabigatran and warfarin groups (rivaroxaban vs. dabigatran: HR = 0.504, 95% CI 0.208-1.223, log-rank P = 0.101; rivaroxaban vs. warfarin: HR = 0.468, 95% CI 0.167-1.316, log-rank P = 0.093). The median [interquartile range] length and width of DRT in the rivaroxaban group were 1.92 [1.68-2.15] mm and 1.49 [1.28-1.76] mm, both significantly lower than those in the dabigatran (length = 2.15 [1.99-2.25] mm, P = 0.036; width = 1.60 [1.54-1.85] mm, P = 0.035) and warfarin groups (length = 2.26 [2.11-2.44] mm, P = 0.006; width = 1.74 [1.54-1.85] mm, P = 0.006). Kaplan-Meier survival analysis indicated that procedural bleeding was more common in the warfarin group. The 12-month incidence of TE was significantly lower in the rivaroxaban group compared to the dabigatran (HR = 0.466, 95% CI 0.221-0.984, log-rank P = 0.029) and warfarin groups (HR = 0.456, 95% CI 0.188-0.966, log-rank P = 0.042). Long-term antithrombotic therapy with reduced dose of rivaroxaban significantly reduced the risk of DRT and composite endpoints without increasing bleeding events, compared to warfarin and dabigatran, for patients following LAAC.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"1"},"PeriodicalIF":2.8000,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697742/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinical effectiveness and safety comparison between direct oral anticoagulants and warfarin for nonvalvular atrial fibrillation patients following percutaneous left atrial appendage closure operation intervention: a prospective observational study.\",\"authors\":\"Yao Yao, Qinchun Jin, Xiaochun Zhang, Qianzhou Lv\",\"doi\":\"10.1186/s40360-024-00834-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The main objective of this study was to investigate the optimal post-left atrial appendage closure (LAAC) anticoagulation strategy, focusing on minimizing device-related thrombosis (DRT) and thromboembolism (TE) events without increasing bleeding risk. After successful LAAC, consecutive participants were treated with 45-day anticoagulants (rivaroxaban 15 mg daily, dabigatran 110 mg twice a day, and warfarin). The efficacy endpoints included DRT, TE, and hospital readmissions due to cardiac caused, while safety endpoints encompassed bleeding events, monitored over a 12-month follow-up period. The incidence of DRT was relatively lower in the rivaroxaban group compared to both the dabigatran and warfarin groups (rivaroxaban vs. dabigatran: HR = 0.504, 95% CI 0.208-1.223, log-rank P = 0.101; rivaroxaban vs. warfarin: HR = 0.468, 95% CI 0.167-1.316, log-rank P = 0.093). The median [interquartile range] length and width of DRT in the rivaroxaban group were 1.92 [1.68-2.15] mm and 1.49 [1.28-1.76] mm, both significantly lower than those in the dabigatran (length = 2.15 [1.99-2.25] mm, P = 0.036; width = 1.60 [1.54-1.85] mm, P = 0.035) and warfarin groups (length = 2.26 [2.11-2.44] mm, P = 0.006; width = 1.74 [1.54-1.85] mm, P = 0.006). Kaplan-Meier survival analysis indicated that procedural bleeding was more common in the warfarin group. The 12-month incidence of TE was significantly lower in the rivaroxaban group compared to the dabigatran (HR = 0.466, 95% CI 0.221-0.984, log-rank P = 0.029) and warfarin groups (HR = 0.456, 95% CI 0.188-0.966, log-rank P = 0.042). Long-term antithrombotic therapy with reduced dose of rivaroxaban significantly reduced the risk of DRT and composite endpoints without increasing bleeding events, compared to warfarin and dabigatran, for patients following LAAC.</p>\",\"PeriodicalId\":9023,\"journal\":{\"name\":\"BMC Pharmacology & Toxicology\",\"volume\":\"26 1\",\"pages\":\"1\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-01-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697742/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Pharmacology & Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s40360-024-00834-7\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Pharmacology & Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s40360-024-00834-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
本研究的主要目的是探讨最佳的左心耳关闭(LAAC)后抗凝策略,重点是在不增加出血风险的情况下最大限度地减少器械相关血栓形成(DRT)和血栓栓塞(TE)事件。LAAC成功后,连续受试者接受45天抗凝治疗(利伐沙班15 mg /天,达比加群110 mg /天2次,华法林)。疗效终点包括DRT、TE和因心脏原因再入院,而安全性终点包括出血事件,在12个月的随访期间监测。与达比加群和华法林组相比,利伐沙班组DRT的发生率相对较低(利伐沙班vs.达比加群:HR = 0.504, 95% CI 0.208-1.223, log-rank P = 0.101;利伐沙班vs华法林:HR = 0.468, 95% CI 0.167-1.316, log-rank P = 0.093)。利伐沙班组DRT长度和宽度的中位数[四分位间距]分别为1.92 [1.68-2.15]mm和1.49 [1.28-1.76]mm,均显著低于达比加群组(长度= 2.15 [1.99-2.25]mm, P = 0.036;宽度= 1.60毫米(1.54 - -1.85),P = 0.035)和华法林组(长度= 2.26 mm (2.11 - -2.44), P = 0.006;宽度= 1.74 [1.54-1.85]mm, P = 0.006)。Kaplan-Meier生存分析显示,华法林组的程序性出血更为常见。利伐沙班组12个月TE发生率显著低于达比加群组(HR = 0.466, 95% CI 0.221 ~ 0.984, log-rank P = 0.029)和华法林组(HR = 0.456, 95% CI 0.188 ~ 0.966, log-rank P = 0.042)。与华法林和达比加群相比,低剂量利伐沙班的长期抗血栓治疗显著降低了LAAC患者发生DRT和复合终点的风险,且不增加出血事件。
Clinical effectiveness and safety comparison between direct oral anticoagulants and warfarin for nonvalvular atrial fibrillation patients following percutaneous left atrial appendage closure operation intervention: a prospective observational study.
The main objective of this study was to investigate the optimal post-left atrial appendage closure (LAAC) anticoagulation strategy, focusing on minimizing device-related thrombosis (DRT) and thromboembolism (TE) events without increasing bleeding risk. After successful LAAC, consecutive participants were treated with 45-day anticoagulants (rivaroxaban 15 mg daily, dabigatran 110 mg twice a day, and warfarin). The efficacy endpoints included DRT, TE, and hospital readmissions due to cardiac caused, while safety endpoints encompassed bleeding events, monitored over a 12-month follow-up period. The incidence of DRT was relatively lower in the rivaroxaban group compared to both the dabigatran and warfarin groups (rivaroxaban vs. dabigatran: HR = 0.504, 95% CI 0.208-1.223, log-rank P = 0.101; rivaroxaban vs. warfarin: HR = 0.468, 95% CI 0.167-1.316, log-rank P = 0.093). The median [interquartile range] length and width of DRT in the rivaroxaban group were 1.92 [1.68-2.15] mm and 1.49 [1.28-1.76] mm, both significantly lower than those in the dabigatran (length = 2.15 [1.99-2.25] mm, P = 0.036; width = 1.60 [1.54-1.85] mm, P = 0.035) and warfarin groups (length = 2.26 [2.11-2.44] mm, P = 0.006; width = 1.74 [1.54-1.85] mm, P = 0.006). Kaplan-Meier survival analysis indicated that procedural bleeding was more common in the warfarin group. The 12-month incidence of TE was significantly lower in the rivaroxaban group compared to the dabigatran (HR = 0.466, 95% CI 0.221-0.984, log-rank P = 0.029) and warfarin groups (HR = 0.456, 95% CI 0.188-0.966, log-rank P = 0.042). Long-term antithrombotic therapy with reduced dose of rivaroxaban significantly reduced the risk of DRT and composite endpoints without increasing bleeding events, compared to warfarin and dabigatran, for patients following LAAC.
期刊介绍:
BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.