Abstract：
BACKGROUND: Direct oral anticoagulant (DOAC) agents are established as the anticoagulation strategy of choice for a variety of clinical risks. Despite this, uncertainty still exists with regard to their efficacy and safety for the prevention of stroke and systemic embolism in some patient populations; most notably those with low body weight (LBW) (<60 kg or body mass index [BMI] <18 kg/m2). Currently, there is a paucity of trial and non-trial data to support a prescriptive recommendation for their use in these patient cohorts. We have carried out a pooled systematic review of the most up to date published data of patients stabilized on various DOAC analogs with the view to ascertaining the exact matrices of their efficacy and safety in these cohorts of patients.
METHODS: We initially carried out a comprehensive search of databases from inception to June 2023 for eligible studies exploring the efficacy and safety of various analogs of direct oral anticoagulants in patients with atrial fibrillation who had low body weight. Databases accessed include PubMed, EMBASE, the Science Citation Index, the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effectiveness. We carried out a weighted comparison of derived pooled odd ratios (with their corresponding confidence intervals) of mortality outcomes between various DOACs using the random effects model.
RESULTS: Thirteen studies (n = 165,205 patients) were included in our meta-analysis. DOAC analogs were associated with increased stroke-related events, composite outcome, and mortality in low body weight patients compared to non-low body weight patients (odds ratio [OR] 1.50, 95% confidence interval [CI] 1.17-1.92), (OR 1.55, 95% CI 1.29-1.86), (OR 2.92, 95% CI 1.87-4.58), respectively. There was no significant difference in the safety outcome (major bleeding events) between the DOAC analogs (OR 1.19, 95% CI 0.93-1.52).
CONCLUSIONS: In this meta-analytical review comprising both real-world and randomized controlled studies, the use of DOAC analogs in low body weight patients (body weight of <60 kg or BMI<18 kg/m2) with atrial fibrillation was associated with increased risks of stroke-related events, composite outcomes, and mortality compared to non-low body weight cohorts patients. At the same time, there was no significant difference in terms of major bleeding events. This finding has provided the first resolution of pervading uncertainty surrounding the use of DOAC analogs in these patient cohorts and suggests the need for follow-up confirmatory systematic studies in this group of patients.
METHODS: We initially carried out a comprehensive search of databases from inception to June 2023 for eligible studies exploring the efficacy and safety of various analogs of direct oral anticoagulants in patients with atrial fibrillation who had low body weight. Databases accessed include PubMed, EMBASE, the Science Citation Index, the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effectiveness. We carried out a weighted comparison of derived pooled odd ratios (with their corresponding confidence intervals) of mortality outcomes between various DOACs using the random effects model.
RESULTS: Thirteen studies (n = 165,205 patients) were included in our meta-analysis. DOAC analogs were associated with increased stroke-related events, composite outcome, and mortality in low body weight patients compared to non-low body weight patients (odds ratio [OR] 1.50, 95% confidence interval [CI] 1.17-1.92), (OR 1.55, 95% CI 1.29-1.86), (OR 2.92, 95% CI 1.87-4.58), respectively. There was no significant difference in the safety outcome (major bleeding events) between the DOAC analogs (OR 1.19, 95% CI 0.93-1.52).
CONCLUSIONS: In this meta-analytical review comprising both real-world and randomized controlled studies, the use of DOAC analogs in low body weight patients (body weight of <60 kg or BMI<18 kg/m2) with atrial fibrillation was associated with increased risks of stroke-related events, composite outcomes, and mortality compared to non-low body weight cohorts patients. At the same time, there was no significant difference in terms of major bleeding events. This finding has provided the first resolution of pervading uncertainty surrounding the use of DOAC analogs in these patient cohorts and suggests the need for follow-up confirmatory systematic studies in this group of patients.
摘要：
背景：直接口服抗凝剂（DOAC）已被确立为多种临床风险的首选抗凝策略。尽管如此,在某些患者人群中,其预防卒中和全身性栓塞的有效性和安全性仍然存在不确定性;最值得注意的是低体重(LBW)患者(<60kg或体重指数[BMI]<18kg/m2).目前,缺乏试验和非试验数据来支持在这些患者队列中使用它们的处方性建议.我们已经对使用各种DOAC类似物稳定的患者的最新公开数据进行了汇总系统评价，以确定这些患者队列中疗效和安全性的确切矩阵。
方法：我们从研究开始到2023年6月对数据库进行了全面检索，以探索各种直接口服抗凝药类似物在低体重房颤患者中的疗效和安全性。访问的数据库包括PubMed、EMBASE,科学引文索引,Cochrane系统评价数据库，和有效性评论摘要数据库。我们使用随机效应模型对各种DOAC之间的死亡率结果的汇总奇数比率（及其相应的置信区间）进行了加权比较。
结果：13项研究（n=165,205例患者）纳入我们的meta分析。DOAC类似物与卒中相关事件增加相关,复合结果，低体重患者与非低体重患者的死亡率（比值比[OR]1.50，95％置信区间[CI]1.17-1.92），（OR1.55，95%CI1.29-1.86），（OR2.92，95%CI1.87-4.58），分别。DOAC类似物之间的安全性结果（主要出血事件）没有显着差异（OR1.19，95％CI0.93-1.52）。
结论：在这个由真实世界和随机对照研究组成的荟萃分析综述中，低体重房颤患者(体重<60kg或BMI<18kg/m2)使用DOAC类似物与卒中相关事件的风险增加相关,综合结果，和死亡率与非低体重队列患者相比。同时,大出血事件无显著差异.这一发现为在这些患者队列中使用DOAC类似物提供了普遍存在的不确定性的第一个解决方案，并表明需要在该组患者中进行后续验证性系统研究。
方法：我们从研究开始到2023年6月对数据库进行了全面检索，以探索各种直接口服抗凝药类似物在低体重房颤患者中的疗效和安全性。访问的数据库包括PubMed、EMBASE,科学引文索引,Cochrane系统评价数据库，和有效性评论摘要数据库。我们使用随机效应模型对各种DOAC之间的死亡率结果的汇总奇数比率（及其相应的置信区间）进行了加权比较。
结果：13项研究（n=165,205例患者）纳入我们的meta分析。DOAC类似物与卒中相关事件增加相关,复合结果，低体重患者与非低体重患者的死亡率（比值比[OR]1.50，95％置信区间[CI]1.17-1.92），（OR1.55，95%CI1.29-1.86），（OR2.92，95%CI1.87-4.58），分别。DOAC类似物之间的安全性结果（主要出血事件）没有显着差异（OR1.19，95％CI0.93-1.52）。
结论：在这个由真实世界和随机对照研究组成的荟萃分析综述中，低体重房颤患者(体重<60kg或BMI<18kg/m2)使用DOAC类似物与卒中相关事件的风险增加相关,综合结果，和死亡率与非低体重队列患者相比。同时,大出血事件无显著差异.这一发现为在这些患者队列中使用DOAC类似物提供了普遍存在的不确定性的第一个解决方案，并表明需要在该组患者中进行后续验证性系统研究。
