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在一项全国性观察性靶向试验中,利伐沙班、阿哌沙班和达比加群的头对头疗效及安全性

Head-to-head efficacy and safety of rivaroxaban, apixaban, and dabigatran in an observational nationwide targeted trial.

作者信息

Talmor-Barkan Yeela, Yacovzada Nancy-Sarah, Rossman Hagai, Witberg Guy, Kalka Iris, Kornowski Ran, Segal Eran

机构信息

Department of Cardiology, Rabin Medical Center, Petah Tikva 4941492, Israel.

Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.

出版信息

Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):26-37. doi: 10.1093/ehjcvp/pvac063.

Abstract

AIMS

The advantages of direct oral anticoagulants (DOACs) over warfarin are well established in atrial fibrillation (AF) patients, however, studies that can guide the selection between different DOACs are limited. The aim was to compare the clinical outcomes of treatment with apixaban, rivaroxaban, and dabigatran in patients with AF.

METHODS AND RESULTS

We conducted a retrospective, nationwide, propensity score-matched-based observational study from Clalit Health Services. Data from 141 992 individuals with AF was used to emulate a target trial for head-to-head comparison of DOACs therapy. Three-matched cohorts of patients assigned to DOACs, from January-2014 through January-2020, were created. One-to-one propensity score matching was performed. Efficacy/safety outcomes were compared using KaplanMeier survival estimates and Cox proportional hazards models. The trial included 56 553 patients (apixaban, n = 35 101; rivaroxaban, n = 15 682; dabigatran, n = 5 770). Mortality and ischaemic stroke rates in patients treated with rivaroxaban were lower compared with apixaban (HR,0.88; 95% CI,0.78-0.99; P,0.037 and HR 0.92; 95% CI,0.86-0.99; P,0.024, respectively). No significant differences in the rates of myocardial infarction, systemic embolism, and overall bleeding were noticed between the different DOACs groups. Patients treated with rivaroxaban demonstrated lower rate of intracranial haemorrhage compared with apixaban (HR,0.86; 95% CI,0.74-1.0; P,0.044). The rate of gastrointestinal bleeding in patients treated with rivaroxaban was higher compared with apixaban (HR, 1.22; 95% CI,1.01-1.44; P, 0.016).

CONCLUSION

We demonstrated significant differences in outcomes between the three studied DOACs. The results emphasize the need for randomized controlled trials that will compare rivaroxaban, apixaban, and dabigatran in order to better guide the selection among them.

摘要

目的

直接口服抗凝剂(DOACs)相对于华法林在房颤(AF)患者中的优势已得到充分证实,然而,能够指导不同DOACs之间选择的研究有限。本研究旨在比较阿哌沙班、利伐沙班和达比加群治疗房颤患者的临床结局。

方法与结果

我们开展了一项基于倾向评分匹配的回顾性全国性观察性研究,数据来源于克拉利特医疗服务机构。141992例房颤患者的数据被用于模拟一项DOACs治疗头对头比较的目标试验。创建了2014年1月至2020年1月期间接受DOACs治疗的三个匹配队列患者。进行了一对一倾向评分匹配。使用Kaplan-Meier生存估计和Cox比例风险模型比较疗效/安全性结局。该试验纳入了56553例患者(阿哌沙班组35101例;利伐沙班组15682例;达比加群组5770例)。与阿哌沙班相比,利伐沙班治疗的患者死亡率和缺血性卒中发生率较低(HR分别为0.88;95%CI为0.78-0.99;P=0.037和HR为0.92;95%CI为0.86-0.99;P=0.024)。不同DOACs组之间心肌梗死、系统性栓塞和总体出血发生率无显著差异。与阿哌沙班相比,利伐沙班治疗的患者颅内出血发生率较低(HR为0.86;95%CI为0.74-1.0;P=0.044)。与阿哌沙班相比,利伐沙班治疗的患者胃肠道出血发生率较高(HR为1.22;95%CI为1.01-1.44;P=0.016)。

结论

我们证明了三种研究的DOACs在结局方面存在显著差异。结果强调需要进行随机对照试验,比较利伐沙班、阿哌沙班和达比加群,以便更好地指导它们之间的选择。

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