Introduction

oral anticoagulant (DOAC) agents are becoming the anticoagulation strategy of choice for most clinical risks for which they are indicated. However, residual uncertainty remains regarding their use in preventing stroke in patients with low bodyweight [< 60 kg or body mass index (BMI) < 18 kg/m²]. We have carried out pooled systematic analyses of published studies to determine the efficacy and safety of these agents compared with warfarin in stroke prevention in patients with low bodyweight.

Methods

We carried out a comprehensive search of electronic databases from inception to June 2023 for eligible studies reporting on the efficacy and safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation who had low bodyweight. These include PubMed, EMBASE, the Cochrane Database of Systematic Reviews, the Science Citation Index, and the Database of Abstracts of Reviews of Effectiveness. Using the random effects model, derived pooled odd ratios (with their corresponding confidence intervals) of mortality outcomes in patient cohorts exposed to direct oral anticoagulants versus warfarin in patients with atrial fibrillation who had low bodyweight.

Results

Nine studies (n = 159,514 patients) were included in our meta-analysis. DOAC analogs were associated with lower stroke recurrence compared with warfarin [odds ratio (OR) 0.66, 95% confidence interval (CI) 0.49–0.9]; however, there was no significant difference in the composite outcome (OR 0.81, 95% CI 0.59–1.09) and mortality (OR 0.82, 95% CI 0.48–1.41). Additionally, DOAC analogs showed a significant reduction in major bleeding events by 30% compared with warfarin (OR 0.70, 95% CI 0.62–0.80).

Conclusion

In this pooled meta-analytical synthesis of studies comprising both real-world and randomized controlled data, the use of DOAC analogs in patients with atrial fibrillation and low bodyweight (< 60 kg or BMI < 18 kg/m²) was associated with a significant reduction in risks of stroke and major bleeding compared with patient cohorts stabilized on warfarin-based therapy. There was uncertainty regarding the composite outcome and mortality point estimate between these two anticoagulation strategies. This finding helps to resolve the uncertainty associated with the use of DOACs in this cohort. Additionally, it suggests the need for confirmatory non-inferiority randomized controlled trials evaluating DOACs versus warfarin in this cohort of patients.

中文翻译：

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直接口服抗凝药与华法林对低体重心房颤动患者的有效性和安全性比较：系统评价和荟萃分析

介绍

口服抗凝剂 (DOAC) 正在成为针对大多数临床风险的首选抗凝策略。然而，关于其在低体重[< 60 kg或体重指数(BMI) < 18 kg/m ² ]患者中预防中风的用途仍然存在不确定性。我们对已发表的研究进行了汇总系统分析，以确定这些药物与华法林相比在预防低体重患者中风方面的有效性和安全性。

方法

我们对电子数据库进行了全面检索，从一开始到 2023 年 6 月，寻找符合条件的研究，报告直接口服抗凝剂与华法林对低体重房颤患者的疗效和安全性。其中包括 PubMed、EMBASE、Cochrane 系统评价数据库、科学引文索引和有效性评价摘要数据库。使用随机效应模型，得出低体重房颤患者暴露于直接口服抗凝剂与华法林的患者队列中死亡率结果的汇总奇数比（及其相应的置信区间）。

结果

我们的荟萃分析纳入了九项研究（n = 159,514 名患者）。与华法林相比，DOAC 类似物可降低中风复发率 [比值比 (OR) 0.66，95% 置信区间 (CI) 0.49–0.9]；然而，综合结局（OR 0.81，95% CI 0.59–1.09）和死亡率（OR 0.82，95% CI 0.48–1.41）没有显着差异。此外，与华法林相比，DOAC 类似物的主要出血事件显着减少 30%（OR 0.70，95% CI 0.62-0.80）。

结论

在这项包含真实世界数据和随机对照数据的研究汇总荟萃分析综合中，在心房颤动和低体重（< 60 kg 或 BMI < 18 kg/m 2 ^）患者中使用 DOAC 类似物与显着的相关性相关。与使用华法林治疗稳定的患者群体相比，中风和大出血的风险降低。这两种抗凝策略之间的综合结果和死亡率点估计存在不确定性。这一发现有助于解决与该队列中使用 DOAC 相关的不确定性。此外，它表明需要进行验证性非劣效性随机对照试验来评估 DOAC 与华法林在这组患者中的疗效。