Department of Cardiology, University Heart and Vascular Center Hamburg, Building O50, Empore, Martinistrasse 52, 20246 Hamburg, Germany.
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Hamburg 20246, Germany.
Eur Heart J Cardiovasc Pharmacother. 2024 Aug 14;10(5):444-453. doi: 10.1093/ehjcvp/pvae042.
Direct oral anticoagulants (DOACs) are increasingly used off-label to treat patients with left ventricular thrombus (LVT). We analysed available meta-data comparing DOACs and vitamin K antagonists (VKAs) for efficacy and safety.
We conducted a systematic search and meta-analysis of observational and randomized data comparing DOACs vs. 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-effects model meta-analysis, and their robustness was investigated using sensitivity and influential analyses.
We identified 22 articles (18 observational studies, 4 small randomized clinical trials) reporting on a total of 3587 patients (2489 VKA vs. 1098 DOAC therapy). The pooled estimates for stroke or systemic embolism [odds ratio (OR): 0.81; 95% confidence interval (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. The use of DOACs 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.
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 with 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.
直接口服抗凝剂(DOACs)越来越多地被超适应证用于治疗左心室血栓(LVT)患者。我们分析了比较 DOACs 和维生素 K 拮抗剂(VKAs)在治疗 LVT 患者的有效性和安全性的现有汇总数据。
我们对比较 LVT 患者中 DOACs 与 VKAs 的观察性和随机数据进行了系统检索和荟萃分析。感兴趣的终点是卒中或全身性栓塞、血栓溶解、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,并通过敏感性和影响分析研究其稳健性。
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),共报告了 3587 例患者(2489 例 VKA 与 1098 例 DOAC 治疗)。卒中或全身性栓塞的汇总估计值[比值比(OR):0.81;95%置信区间(CI):0.57,1.15]和血栓溶解的汇总估计值(OR:1.12;95%CI:0.86,1.46)相当,并且整个纳入研究的异质性较低。与使用 VKAs 相比,使用 DOACs 与全因死亡的可能性较低相关(OR:0.65;95%CI:0.46,0.92)和复合出血终点(OR:0.67;95%CI:0.47,0.97)。特别是对于观察性报告,存在明显的偏倚风险,在漏斗图中提示存在一些发表偏倚。
在对主要观察性数据的全面分析中,与 VKAs 治疗相比,使用 DOACs 并未显著降低卒中或全身性栓塞或血栓溶解的发生率。使用 DOACs 与全因死亡率降低和出血事件减少相关。需要进行足够规模的随机临床试验来证实这些发现,这可能允许在 LVT 患者中更广泛地采用 DOACs。