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}
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.
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.