Kiara Bautista, Anisa Bici, Denise Sutter-Long, Elizabeth Liza Renner, Erin Mouland, Mary Jo Elder, Nhan Hoang, Amir Farid, Nghi Ha
{"title":"在现实世界环境中，与华法林相比，直接口服抗凝剂对体重指数≥40 kg/m2患者的安全性和有效性","authors":"Kiara Bautista, Anisa Bici, Denise Sutter-Long, Elizabeth Liza Renner, Erin Mouland, Mary Jo Elder, Nhan Hoang, Amir Farid, Nghi Ha","doi":"10.1177/87551225261445649","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) and venous thromboembolism (VTE) are common conditions requiring anticoagulation in patients with severe obesity (body mass index ≥40 kg/m<sup>2</sup>). Comparative safety and efficacy data for direct oral anticoagulants (DOACs) vs warfarin in this population remain limited.</p><p><strong>Objective: </strong>To compare the safety and efficacy of DOACs and warfarin in non-valvular atrial fibrillation (NVAF) and VTE in patients with severe obesity in a real-world setting.</p><p><strong>Methods: </strong>This single-center, retrospective matched cohort study included adults with severe obesity receiving a DOAC or warfarin for NVAF or VTE from January 1, 2019, to December 31, 2024. Patients were matched by age, sex, and indication. Primary outcomes were composite thrombotic events (recurrent VTE or ischemic stroke occurrence) and composite bleeding events (clinically relevant non-major and major bleed). Secondary outcomes were assessments of predictors for these events.</p><p><strong>Results: </strong>The study included 182 patients, 91 per cohort. Composite bleeding was significantly higher in the warfarin group (39.6% vs 23.1%, <i>P</i> = 0.017), but it was not significantly different after adjustment for time on therapy. Composite thrombotic events were similar between groups (12.1% vs 9.9%, <i>P</i> = 0.89). History of major bleed (hazard ratio [HR] = 2.37, <i>P</i> = 0.022, 95% confidence interval [CI] = [1.13-4.96]) and concomitant antiplatelet use (HR = 3.80, <i>P</i> < 0.001, 95% CI = [1.98-7.26]) were predictors for bleeding. History of cerebrovascular accident (CVA)/transient ischemic attack (TIA) (HR = 3.34, <i>P</i> = 0.014, 95% CI = [1.28-8.74]) was a predictor for thrombosis.</p><p><strong>Conclusion: </strong>DOACs demonstrated comparable safety and efficacy to warfarin in patients with severe obesity with NVAF or VTE.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225261445649"},"PeriodicalIF":1.3000,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13132985/pdf/","citationCount":"0","resultStr":"{\"title\":\"Safety and Efficacy of Direct Oral Anticoagulants Compared to Warfarin in Patients With Body Mass Index ≥40 kg/m<sup>2</sup> in a Real-World Setting.\",\"authors\":\"Kiara Bautista, Anisa Bici, Denise Sutter-Long, Elizabeth Liza Renner, Erin Mouland, Mary Jo Elder, Nhan Hoang, Amir Farid, Nghi Ha\",\"doi\":\"10.1177/87551225261445649\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Atrial fibrillation (AF) and venous thromboembolism (VTE) are common conditions requiring anticoagulation in patients with severe obesity (body mass index ≥40 kg/m<sup>2</sup>). Comparative safety and efficacy data for direct oral anticoagulants (DOACs) vs warfarin in this population remain limited.</p><p><strong>Objective: </strong>To compare the safety and efficacy of DOACs and warfarin in non-valvular atrial fibrillation (NVAF) and VTE in patients with severe obesity in a real-world setting.</p><p><strong>Methods: </strong>This single-center, retrospective matched cohort study included adults with severe obesity receiving a DOAC or warfarin for NVAF or VTE from January 1, 2019, to December 31, 2024. Patients were matched by age, sex, and indication. Primary outcomes were composite thrombotic events (recurrent VTE or ischemic stroke occurrence) and composite bleeding events (clinically relevant non-major and major bleed). Secondary outcomes were assessments of predictors for these events.</p><p><strong>Results: </strong>The study included 182 patients, 91 per cohort. Composite bleeding was significantly higher in the warfarin group (39.6% vs 23.1%, <i>P</i> = 0.017), but it was not significantly different after adjustment for time on therapy. Composite thrombotic events were similar between groups (12.1% vs 9.9%, <i>P</i> = 0.89). History of major bleed (hazard ratio [HR] = 2.37, <i>P</i> = 0.022, 95% confidence interval [CI] = [1.13-4.96]) and concomitant antiplatelet use (HR = 3.80, <i>P</i> < 0.001, 95% CI = [1.98-7.26]) were predictors for bleeding. History of cerebrovascular accident (CVA)/transient ischemic attack (TIA) (HR = 3.34, <i>P</i> = 0.014, 95% CI = [1.28-8.74]) was a predictor for thrombosis.</p><p><strong>Conclusion: </strong>DOACs demonstrated comparable safety and efficacy to warfarin in patients with severe obesity with NVAF or VTE.</p>\",\"PeriodicalId\":16796,\"journal\":{\"name\":\"Journal of Pharmacy Technology\",\"volume\":\" \",\"pages\":\"87551225261445649\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2026-04-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13132985/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pharmacy Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/87551225261445649\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmacy Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/87551225261445649","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
背景：房颤（AF）和静脉血栓栓塞（VTE）是严重肥胖（体重指数≥40 kg/m2）患者需要抗凝治疗的常见疾病。在这一人群中，直接口服抗凝剂（DOACs）与华法林的安全性和有效性比较数据仍然有限。目的：比较DOACs和华法林治疗重度肥胖患者非瓣膜性心房颤动（NVAF）和静脉血栓栓塞（VTE）的安全性和有效性。方法：这项单中心、回顾性匹配队列研究纳入了2019年1月1日至2024年12月31日期间接受DOAC或华法林治疗非瓣膜性房颤或静脉血栓栓塞的严重肥胖成年人。患者按年龄、性别和适应症进行匹配。主要结局是复合血栓事件（静脉血栓栓塞复发或缺血性卒中发生）和复合出血事件（临床相关的非大出血和大出血）。次要结局是评估这些事件的预测因子。结果：该研究包括182例患者，每个队列91例。华法林组复合出血发生率显著高于华法林组（39.6% vs 23.1%, P = 0.017），但调整治疗时间后差异无统计学意义。两组间的复合血栓事件相似（12.1% vs 9.9%, P = 0.89）。大出血史（风险比[HR] = 2.37, P = 0.022, 95%可信区间[CI] =[1.13-4.96]）和合并使用抗血小板药物（HR = 3.80, P < 0.001, 95% CI =[1.98-7.26]）是出血的预测因素。脑血管意外(CVA)/短暂性脑缺血发作（TIA）史（HR = 3.34, P = 0.014, 95% CI =[1.28-8.74]）是血栓形成的预测因子。结论：DOACs在重度肥胖合并非瓣膜性房颤或静脉血栓栓塞患者中的安全性和有效性与华法林相当。
Safety and Efficacy of Direct Oral Anticoagulants Compared to Warfarin in Patients With Body Mass Index ≥40 kg/m2 in a Real-World Setting.
Background: Atrial fibrillation (AF) and venous thromboembolism (VTE) are common conditions requiring anticoagulation in patients with severe obesity (body mass index ≥40 kg/m2). Comparative safety and efficacy data for direct oral anticoagulants (DOACs) vs warfarin in this population remain limited.
Objective: To compare the safety and efficacy of DOACs and warfarin in non-valvular atrial fibrillation (NVAF) and VTE in patients with severe obesity in a real-world setting.
Methods: This single-center, retrospective matched cohort study included adults with severe obesity receiving a DOAC or warfarin for NVAF or VTE from January 1, 2019, to December 31, 2024. Patients were matched by age, sex, and indication. Primary outcomes were composite thrombotic events (recurrent VTE or ischemic stroke occurrence) and composite bleeding events (clinically relevant non-major and major bleed). Secondary outcomes were assessments of predictors for these events.
Results: The study included 182 patients, 91 per cohort. Composite bleeding was significantly higher in the warfarin group (39.6% vs 23.1%, P = 0.017), but it was not significantly different after adjustment for time on therapy. Composite thrombotic events were similar between groups (12.1% vs 9.9%, P = 0.89). History of major bleed (hazard ratio [HR] = 2.37, P = 0.022, 95% confidence interval [CI] = [1.13-4.96]) and concomitant antiplatelet use (HR = 3.80, P < 0.001, 95% CI = [1.98-7.26]) were predictors for bleeding. History of cerebrovascular accident (CVA)/transient ischemic attack (TIA) (HR = 3.34, P = 0.014, 95% CI = [1.28-8.74]) was a predictor for thrombosis.
Conclusion: DOACs demonstrated comparable safety and efficacy to warfarin in patients with severe obesity with NVAF or VTE.
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