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直接口服抗凝剂与华法林在正常体重和极端体重患者中治疗心房颤动或静脉血栓栓塞的安全性和有效性结果评估。

Evaluation of safety and efficacy outcomes of direct oral anticoagulants versus warfarin in normal and extreme body weights for the treatment of atrial fibrillation or venous thromboembolism.

作者信息

Novak Alison R, Shakowski Courtney, Trujillo Toby C, Wright Garth C, Mueller Scott W, Kiser Tyree H

机构信息

Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 E Montview Blvd, C238, Aurora, CO, 80045, USA.

Department of Pharmacy, University of Colorado Hospital, UCHealth, Aurora, CO, USA.

出版信息

J Thromb Thrombolysis. 2022 Aug;54(2):276-286. doi: 10.1007/s11239-022-02668-8. Epub 2022 Jun 10.

Abstract

Despite evolving evidence, the use of direct oral anticoagulants (DOACs) in patients with extremes of body weight remains controversial. This study aimed to measure the impact of DOACs compared to warfarin on safety and efficacy outcomes in extreme body weight patients. This multi-center, health system, retrospective study examined the outcomes of patients with all body weights and extreme body weights prescribed a DOAC (rivaroxaban, apixaban, dabigatran, edoxaban) or warfarin for atrial fibrillation or venous thromboembolism over a 9-year period. The primary outcome was a composite of thromboembolism, symptomatic recurrent VTE, or severe bleeding; analyzed by pre-determined BMI cutoffs. A total of 19,697 patients were included in the study: 11,604 in the DOAC group and in the 8093 in the warfarin group. 295 patients were underweight and 9108 patients were pre-obese to obese class 3. After adjusting for potential confounders, warfarin patients had higher odds of experiencing the composite outcome compared to DOAC patients (OR 1.337, 95% CI 1.212-1.475). Additionally, obese patients were 24.6% more likely to experience the outcome compared to normal BMI patients. Adjusted modeling showed that warfarin patients experienced higher bleed rates compared to DOAC patients (OR 1.432, 95% CI 1.266-1.620). Obese patients were less likely to be diagnosed with a bleed (OR 0.749, 95% CI 0.658-0.854), and underweight patients were more likely to be diagnosed with a bleed (OR 1.522, 95% CI 1.095-2.115) compared to normal BMI patients. In conclusion, DOACs for atrial fibrillation or VTE in patients with extreme body weights appear safe and effective when compared to warfarin.

摘要

尽管有越来越多的证据,但在体重过轻或过重的患者中使用直接口服抗凝剂(DOACs)仍存在争议。本研究旨在衡量DOACs与华法林相比,对体重过轻或过重患者的安全性和有效性结果的影响。这项多中心、卫生系统的回顾性研究,考察了在9年期间,所有体重和体重过轻或过重的患者,因房颤或静脉血栓栓塞而接受DOACs(利伐沙班、阿哌沙班、达比加群、依度沙班)或华法林治疗后的结果。主要结局是血栓栓塞、有症状的复发性静脉血栓栓塞或严重出血的复合结局;按预先确定的体重指数(BMI)临界值进行分析。该研究共纳入19,697名患者:DOAC组11,604名,华法林组8093名。295名患者体重过轻,9108名患者为肥胖前期至3级肥胖。在对潜在混杂因素进行校正后,与DOAC组患者相比,华法林组患者出现复合结局的几率更高(比值比[OR]1.337,95%置信区间[CI]1.212-1.475)。此外,与BMI正常的患者相比,肥胖患者出现该结局的可能性高24.6%。校正模型显示,与DOAC组患者相比,华法林组患者的出血率更高(OR 1.432,95%CI 1.266-1.620)。与BMI正常的患者相比,肥胖患者被诊断为出血的可能性较小(OR 0.749,95%CI 0.658-0.854),而体重过轻的患者被诊断为出血的可能性较大(OR 1.522,95%CI 1.095-2.115)。总之,与华法林相比,体重过轻或过重的患者使用DOACs治疗房颤或静脉血栓栓塞似乎是安全有效的。

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