Paige Hanke, Ma Emmanuelle Domingo, Ghenella Salanio, Kulsoom Ahmed, Jingyu Hu, Kristin Hendricks, Jacob Howard, Tori Hashimura, Chris Guiliano, Bradley J Haan, Tsz Hin Ng, Denise Kelley, Tamara Knight, Kathleen Koopman, Monika Obstoj, Thomas Breeden, Dumitru Sirbu, Meredith Romano, Andrew Harpenau, Rebecca Konneker, Jason Acevedo, Neil Pan, Stephanie B Edwin
{"title":"Apixaban versus warfarin for treatment of venous thromboembolism in patients with severe renal impairment: a multicenter study.","authors":"Paige Hanke, Ma Emmanuelle Domingo, Ghenella Salanio, Kulsoom Ahmed, Jingyu Hu, Kristin Hendricks, Jacob Howard, Tori Hashimura, Chris Guiliano, Bradley J Haan, Tsz Hin Ng, Denise Kelley, Tamara Knight, Kathleen Koopman, Monika Obstoj, Thomas Breeden, Dumitru Sirbu, Meredith Romano, Andrew Harpenau, Rebecca Konneker, Jason Acevedo, Neil Pan, Stephanie B Edwin","doi":"10.1007/s11239-025-03075-5","DOIUrl":null,"url":null,"abstract":"<p><p>Limited evidence exists regarding the use of factor Xa inhibitors for the treatment of venous thromboembolism (VTE) in patients with severe renal impairment. Notably, these patients were excluded from clinical trials.The goal of this study was to examine the safety and effectiveness of apixaban versus warfarin for the treatment of acute VTE in patients with severe renal impairment.This retrospective cohort study was conducted across 36 Ascension Health sites between 2014 and 2024. Adult patients receiving apixaban or warfarin for VTE treatment with severe renal impairment were included. The primary outcome was time to composite bleeding event within six months.This study included 1200 patients receiving apixaban and 600 patients receiving warfarin. Overall, 23.4% of the study population had ESRD requiring renal replacement therapy. Among patients not requiring renal replacement therapy, stage IV CKD was most common (43.8%). No difference in time to composite bleeding events (HR 1.01; 95% CI 0.74-1.38, p = 0.97) or recurrent VTE (HR 1.24; 95% CI 0.70-2.18, p = 0.46) were noted after controlling for confounders. Furthermore, major bleeding (4.7% vs. 7.5%, p = 0.43) and clinically-relevant non-major bleeding (4.3% vs. 6.2%, p = 0.08) were similar between groups. Apixaban was associated with a significantly reduced incidence of anticoagulation-related ED admission (6.8% vs. 9.8%, p = 0.02) compared to warfarin. Anticoagulation-related readmission (7.4% vs. 8%, p = 0.66) and time to all-cause mortality (5.2% vs. 6.2%, p = 0.38) were similar between groups.No differences in safety or effectiveness were noted between apixaban and warfarin, providing encouraging evidence to support the use of apixaban for treatment of acute VTE in patients with severe renal impairment.</p>","PeriodicalId":17546,"journal":{"name":"Journal of Thrombosis and Thrombolysis","volume":" ","pages":"380-390"},"PeriodicalIF":2.2000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Thrombosis and Thrombolysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11239-025-03075-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Limited evidence exists regarding the use of factor Xa inhibitors for the treatment of venous thromboembolism (VTE) in patients with severe renal impairment. Notably, these patients were excluded from clinical trials.The goal of this study was to examine the safety and effectiveness of apixaban versus warfarin for the treatment of acute VTE in patients with severe renal impairment.This retrospective cohort study was conducted across 36 Ascension Health sites between 2014 and 2024. Adult patients receiving apixaban or warfarin for VTE treatment with severe renal impairment were included. The primary outcome was time to composite bleeding event within six months.This study included 1200 patients receiving apixaban and 600 patients receiving warfarin. Overall, 23.4% of the study population had ESRD requiring renal replacement therapy. Among patients not requiring renal replacement therapy, stage IV CKD was most common (43.8%). No difference in time to composite bleeding events (HR 1.01; 95% CI 0.74-1.38, p = 0.97) or recurrent VTE (HR 1.24; 95% CI 0.70-2.18, p = 0.46) were noted after controlling for confounders. Furthermore, major bleeding (4.7% vs. 7.5%, p = 0.43) and clinically-relevant non-major bleeding (4.3% vs. 6.2%, p = 0.08) were similar between groups. Apixaban was associated with a significantly reduced incidence of anticoagulation-related ED admission (6.8% vs. 9.8%, p = 0.02) compared to warfarin. Anticoagulation-related readmission (7.4% vs. 8%, p = 0.66) and time to all-cause mortality (5.2% vs. 6.2%, p = 0.38) were similar between groups.No differences in safety or effectiveness were noted between apixaban and warfarin, providing encouraging evidence to support the use of apixaban for treatment of acute VTE in patients with severe renal impairment.
关于使用Xa因子抑制剂治疗严重肾功能损害患者的静脉血栓栓塞(VTE)的证据有限。值得注意的是,这些患者被排除在临床试验之外。本研究的目的是检验阿哌沙班与华法林治疗急性静脉血栓栓塞合并严重肾功能损害患者的安全性和有效性。这项回顾性队列研究于2014年至2024年间在36个阿森松健康中心进行。接受阿哌沙班或华法林治疗静脉血栓栓塞并伴有严重肾功能损害的成年患者纳入研究。主要观察指标为6个月内发生复合出血事件的时间。本研究纳入1200例接受阿哌沙班治疗的患者和600例接受华法林治疗的患者。总体而言,23.4%的研究人群患有ESRD,需要肾脏替代治疗。在不需要肾脏替代治疗的患者中,IV期CKD最常见(43.8%)。复合出血事件发生时间无差异(HR 1.01;95% CI 0.74-1.38, p = 0.97)或复发性静脉血栓栓塞(HR 1.24;95% CI 0.70-2.18, p = 0.46)。此外,两组间大出血(4.7% vs. 7.5%, p = 0.43)和临床相关的非大出血(4.3% vs. 6.2%, p = 0.08)相似。与华法林相比,阿哌沙班与抗凝相关ED入院发生率显著降低相关(6.8%比9.8%,p = 0.02)。两组抗凝相关再入院率(7.4%比8%,p = 0.66)和全因死亡率(5.2%比6.2%,p = 0.38)相似。阿哌沙班和华法林在安全性和有效性方面没有差异,这为阿哌沙班治疗急性静脉血栓栓塞合并严重肾功能损害患者提供了令人鼓舞的证据。
期刊介绍:
The Journal of Thrombosis and Thrombolysis is a long-awaited resource for contemporary cardiologists, hematologists, vascular medicine specialists and clinician-scientists actively involved in treatment decisions and clinical investigation of thrombotic disorders involving the cardiovascular and cerebrovascular systems. The principal focus of the Journal centers on the pathobiology of thrombosis and vascular disorders and the use of anticoagulants, platelet antagonists, cell-based therapies and interventions in scientific investigation, clinical-translational research and patient care.
The Journal will publish original work which emphasizes the interface between fundamental scientific principles and clinical investigation, stimulating an interdisciplinary and scholarly dialogue in thrombosis and vascular science. Published works will also define platforms for translational research, drug development, clinical trials and patient-directed applications. The Journal of Thrombosis and Thrombolysis'' integrated format will expand the reader''s knowledge base and provide important insights for both the investigation and direct clinical application of the most rapidly growing fields in medicine-thrombosis and vascular science.