Abstract：
OBJECTIVE: Direct oral anticoagulants (DOACs) are increasingly used off-label to treat patients with left ventricular thrombus (LVT). We analyzed available meta-data comparing DOACs and vitamin K antagonists (VKAs) for efficacy and safety.
METHODS: We conducted a systematic search and meta-analysis of observational and randomized data comparing DOACs versus VKAs in patients with LVT. Endpoints of interest were stroke or systemic embolism, thrombus resolution, all-cause death, and a composite bleeding endpoint. Estimates were pooled using a random-effect model meta-analysis, and their robustness was investigated using sensitivity and influential analyses.
RESULTS: We identified 22 articles (18 observational studies, 4 small randomized clinical trials) reporting on a total of 3,587 patients (2,489 VKA vs. 1,098 DOAC therapy). The pooled estimates for stroke or systemic embolism (OR 0.81; 95% CI [0.57, 1.15]) and thrombus resolution (OR 1.12; 95% CI [0.86; 1.46]) were comparable, and there was low heterogeneity overall across the included studies. DOAC use was associated with lower odds of all-cause death (OR 0.65; 95%CI [0.46; 0.92]) and a composite bleeding endpoint (OR 0.67; 95%CI [0.47; 0.97]). A risk of bias was evident particularly for observational reports, with some publication bias suggested in funnel plots.
CONCLUSIONS: In this comprehensive analysis of mainly observational data, the use of DOACs was not associated with a significant difference in stroke or systemic embolism, or thrombus resolution compared to VKA therapy. The use of DOACs was associated with a lower rate of all-cause death and fewer bleeding events. Adequately sized randomized clinical trials are needed to confirm these findings, which could allow a wider adoption of DOACs in patients with LVT.
METHODS: We conducted a systematic search and meta-analysis of observational and randomized data comparing DOACs versus VKAs in patients with LVT. Endpoints of interest were stroke or systemic embolism, thrombus resolution, all-cause death, and a composite bleeding endpoint. Estimates were pooled using a random-effect model meta-analysis, and their robustness was investigated using sensitivity and influential analyses.
RESULTS: We identified 22 articles (18 observational studies, 4 small randomized clinical trials) reporting on a total of 3,587 patients (2,489 VKA vs. 1,098 DOAC therapy). The pooled estimates for stroke or systemic embolism (OR 0.81; 95% CI [0.57, 1.15]) and thrombus resolution (OR 1.12; 95% CI [0.86; 1.46]) were comparable, and there was low heterogeneity overall across the included studies. DOAC use was associated with lower odds of all-cause death (OR 0.65; 95%CI [0.46; 0.92]) and a composite bleeding endpoint (OR 0.67; 95%CI [0.47; 0.97]). A risk of bias was evident particularly for observational reports, with some publication bias suggested in funnel plots.
CONCLUSIONS: In this comprehensive analysis of mainly observational data, the use of DOACs was not associated with a significant difference in stroke or systemic embolism, or thrombus resolution compared to VKA therapy. The use of DOACs was associated with a lower rate of all-cause death and fewer bleeding events. Adequately sized randomized clinical trials are needed to confirm these findings, which could allow a wider adoption of DOACs in patients with LVT.
摘要：
目的：直接口服抗凝剂（DOAC）越来越多地用于治疗左心室血栓（LVT）患者。我们分析了现有的meta数据，比较了DOAC和维生素K拮抗剂（VKAs）的疗效和安全性。
方法：我们对LVT患者DOAC与VKAs的观察性和随机数据进行了系统搜索和荟萃分析。感兴趣的终点是中风或全身性栓塞，血栓分辨率,全因死亡,和复合出血终点。使用随机效应模型荟萃分析汇总估计值，并使用敏感性和影响力分析研究了它们的稳健性。
结果：我们确定了22篇文章(18项观察性研究，4项小型随机临床试验），共报告3,587例患者（2,489例VKA与1098DOAC治疗）。卒中或全身性栓塞（OR0.81;95%CI[0.57,1.15]）和血栓消退（OR1.12;95%CI[0.86;1.46]）的汇总估计值具有可比性，纳入研究总体异质性较低。DOAC使用与较低的全因死亡几率(OR0.65;95CI[0.46;0.92])和复合出血终点(OR0.67;95CI[0.47;0.97])相关。偏见的风险很明显，特别是对于观察性报告，在漏斗图中提出了一些发表偏倚。
结论：在对主要观测数据的综合分析中，DOAC的使用与卒中或全身性栓塞的显著差异无关，或与VKA治疗相比的血栓分辨率。DOAC的使用与较低的全因死亡率和较少的出血事件相关。需要足够大小的随机临床试验来证实这些发现，这可以允许LVT患者更广泛地采用DOAC。
方法：我们对LVT患者DOAC与VKAs的观察性和随机数据进行了系统搜索和荟萃分析。感兴趣的终点是中风或全身性栓塞，血栓分辨率,全因死亡,和复合出血终点。使用随机效应模型荟萃分析汇总估计值，并使用敏感性和影响力分析研究了它们的稳健性。
结果：我们确定了22篇文章(18项观察性研究，4项小型随机临床试验），共报告3,587例患者（2,489例VKA与1098DOAC治疗）。卒中或全身性栓塞（OR0.81;95%CI[0.57,1.15]）和血栓消退（OR1.12;95%CI[0.86;1.46]）的汇总估计值具有可比性，纳入研究总体异质性较低。DOAC使用与较低的全因死亡几率(OR0.65;95CI[0.46;0.92])和复合出血终点(OR0.67;95CI[0.47;0.97])相关。偏见的风险很明显，特别是对于观察性报告，在漏斗图中提出了一些发表偏倚。
结论：在对主要观测数据的综合分析中，DOAC的使用与卒中或全身性栓塞的显著差异无关，或与VKA治疗相比的血栓分辨率。DOAC的使用与较低的全因死亡率和较少的出血事件相关。需要足够大小的随机临床试验来证实这些发现，这可以允许LVT患者更广泛地采用DOAC。
