直接口服抗凝阿哌沙班用于左心室辅助装置(DOAC LVAD)研究的两年结果

IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Aditya Mehta, Pramita Bagchi, Mary Looby, Matthew Dimond, Iyad Isseh, Allman Rollins, Ahmad Abdul-Aziz, Jamie L W Kennedy, Daniel Tang, Wendy Sheaffer, Meredith Snipes, Bhruga Shah, Shashank S Sinha, Christopher M O'Connor, Palak Shah
{"title":"直接口服抗凝阿哌沙班用于左心室辅助装置(DOAC LVAD)研究的两年结果","authors":"Aditya Mehta, Pramita Bagchi, Mary Looby, Matthew Dimond, Iyad Isseh, Allman Rollins, Ahmad Abdul-Aziz, Jamie L W Kennedy, Daniel Tang, Wendy Sheaffer, Meredith Snipes, Bhruga Shah, Shashank S Sinha, Christopher M O'Connor, Palak Shah","doi":"10.1016/j.healun.2025.08.012","DOIUrl":null,"url":null,"abstract":"<p><p>Anticoagulation with apixaban was previously demonstrated to be feasible without excess hemocompatibility-related adverse events (HRAEs) at 6 months but longer-term data on use of apixaban is lacking. We report 2-year outcomes of patients enrolled into the DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) study. The primary study outcome was death or major HRAE (stroke, device thrombosis, major bleeding, aortic root thrombus, and/or arterial non-central nervous system thromboembolism). Patients were randomized to treatment with apixaban (5 mg twice daily, without dose adjustment) as compared to warfarin (INR goal of 2.0 to 2.5). A total of 30 patients were randomized (16 to apixaban, 14 to warfarin). At 2-years, the primary outcome occurred in 2 patients (12.5%) in the apixaban group compared to 6 patients (43%) in the warfarin group (p = 0.087). In the apixaban group, HRAEs occurred in 1 patient (6.3%, major bleeding), compared to 5 HRAEs with warfarin (35.7%, 1 hemorrhagic stroke, 3 major bleeds, and 1 right ventricular thrombus formation, p = 0.07). All bleeding episodes were gastrointestinal. These findings support the long-term feasibility of apixaban anticoagulation in patients with a LVAD and underscore the need for larger randomized trials to confirm these findings.</p>","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":" ","pages":""},"PeriodicalIF":6.0000,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Two-year outcomes in the direct oral anticoagulant apixaban in left ventricular assist devices (DOAC LVAD) study.\",\"authors\":\"Aditya Mehta, Pramita Bagchi, Mary Looby, Matthew Dimond, Iyad Isseh, Allman Rollins, Ahmad Abdul-Aziz, Jamie L W Kennedy, Daniel Tang, Wendy Sheaffer, Meredith Snipes, Bhruga Shah, Shashank S Sinha, Christopher M O'Connor, Palak Shah\",\"doi\":\"10.1016/j.healun.2025.08.012\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Anticoagulation with apixaban was previously demonstrated to be feasible without excess hemocompatibility-related adverse events (HRAEs) at 6 months but longer-term data on use of apixaban is lacking. We report 2-year outcomes of patients enrolled into the DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) study. The primary study outcome was death or major HRAE (stroke, device thrombosis, major bleeding, aortic root thrombus, and/or arterial non-central nervous system thromboembolism). Patients were randomized to treatment with apixaban (5 mg twice daily, without dose adjustment) as compared to warfarin (INR goal of 2.0 to 2.5). A total of 30 patients were randomized (16 to apixaban, 14 to warfarin). At 2-years, the primary outcome occurred in 2 patients (12.5%) in the apixaban group compared to 6 patients (43%) in the warfarin group (p = 0.087). In the apixaban group, HRAEs occurred in 1 patient (6.3%, major bleeding), compared to 5 HRAEs with warfarin (35.7%, 1 hemorrhagic stroke, 3 major bleeds, and 1 right ventricular thrombus formation, p = 0.07). All bleeding episodes were gastrointestinal. These findings support the long-term feasibility of apixaban anticoagulation in patients with a LVAD and underscore the need for larger randomized trials to confirm these findings.</p>\",\"PeriodicalId\":15900,\"journal\":{\"name\":\"Journal of Heart and Lung Transplantation\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.0000,\"publicationDate\":\"2025-08-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Heart and Lung Transplantation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.healun.2025.08.012\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Heart and Lung Transplantation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.healun.2025.08.012","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0

摘要

阿哌沙班抗凝以前被证明是可行的,在6个月时没有过多的血液相容性相关不良事件(HRAEs),但缺乏使用阿哌沙班的长期数据。我们报告了DOAC LVAD(左心室辅助装置中直接口服抗凝阿哌沙班血液相容性评估)研究中患者的两年结果。主要研究结果为死亡或严重HRAE(中风、器械血栓形成、大出血、主动脉根血栓和/或动脉非中枢神经系统血栓栓塞)。与华法林(INR目标为2.0 - 2.5)相比,患者随机接受阿哌沙班(5mg,每日两次,不调整剂量)治疗,30例患者随机接受(16例阿哌沙班,14例华法林)。两年时,阿哌沙班组有2例患者(12.5%)出现主要结局,华法林组有6例患者(43%)出现主要结局(p = 0.087)。阿哌沙班组发生HRAEs 1例(6.3%,大出血),华法林组发生HRAEs 5例(35.7%,出血性卒中1例,大出血3例,右室血栓形成1例,p = 0.07)。所有出血均发生在胃肠道。这些发现支持阿哌沙班抗凝治疗LVAD患者的长期可行性,并强调需要更大规模的随机试验来证实这些发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Two-year outcomes in the direct oral anticoagulant apixaban in left ventricular assist devices (DOAC LVAD) study.

Anticoagulation with apixaban was previously demonstrated to be feasible without excess hemocompatibility-related adverse events (HRAEs) at 6 months but longer-term data on use of apixaban is lacking. We report 2-year outcomes of patients enrolled into the DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) study. The primary study outcome was death or major HRAE (stroke, device thrombosis, major bleeding, aortic root thrombus, and/or arterial non-central nervous system thromboembolism). Patients were randomized to treatment with apixaban (5 mg twice daily, without dose adjustment) as compared to warfarin (INR goal of 2.0 to 2.5). A total of 30 patients were randomized (16 to apixaban, 14 to warfarin). At 2-years, the primary outcome occurred in 2 patients (12.5%) in the apixaban group compared to 6 patients (43%) in the warfarin group (p = 0.087). In the apixaban group, HRAEs occurred in 1 patient (6.3%, major bleeding), compared to 5 HRAEs with warfarin (35.7%, 1 hemorrhagic stroke, 3 major bleeds, and 1 right ventricular thrombus formation, p = 0.07). All bleeding episodes were gastrointestinal. These findings support the long-term feasibility of apixaban anticoagulation in patients with a LVAD and underscore the need for larger randomized trials to confirm these findings.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
10.10
自引率
6.70%
发文量
1667
审稿时长
69 days
期刊介绍: The Journal of Heart and Lung Transplantation, the official publication of the International Society for Heart and Lung Transplantation, brings readers essential scholarly and timely information in the field of cardio-pulmonary transplantation, mechanical and biological support of the failing heart, advanced lung disease (including pulmonary vascular disease) and cell replacement therapy. Importantly, the journal also serves as a medium of communication of pre-clinical sciences in all these rapidly expanding areas.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信