Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Cardiovasc Drugs Ther. 2019 Jun;33(3):339-352. doi: 10.1007/s10557-019-06869-x.
Clinical guidelines recommend peri-cardioversion anticoagulation in patients with atrial fibrillation (AF). We performed a systematic review and meta-analysis to compare the safety and efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with AF undergoing cardioversion.
We searched CENTRAL, MEDLINE, and EMBASE for randomized controlled trials (RCTs) and observational studies comparing DOACs to VKAs in patients undergoing cardioversion for AF. We performed title, abstract, and full-text screening, data extraction, and risk of bias evaluation independently and in duplicate. We pooled data using a random effects model and evaluated the overall quality of evidence using Grading of Recommendations Assessment, Development and Evaluation.
We identified three eligible RCTs (n = 5203) and 21 observational studies (n = 11,855). The three RCTs and four observational studies were at low risk of bias. In RCTs (mean follow-up, 30 days), thromboembolic events occurred in 0.18% of patients receiving DOACs, as compared with 0.55% receiving VKAs (relative risk [RR] 0.40, 95% CI [0.13, 1.24], moderate quality). Major bleeding occurred in 0.42% of patients receiving DOACs as compared with 0.64% receiving VKAs (RR 0.62, 95% CI [0.28, 1.35], moderate quality), and death occurred in 0.28% of patients receiving DOACs as compared with 0.38% receiving VKAs (RR 0.70, 95% CI [0.23, 2.10], low quality). Confidence in the estimates of effect for observational studies was very low.
DOACs peri-cardioversion in patients with AF appears safe from both a bleeding and thromboembolic risk perspective. Available evidence supports the use of DOACs as standard of care peri-cardioversion in patients with AF.
临床指南建议在心房颤动(AF)患者行电复律时进行抗凝治疗。我们进行了一项系统评价和荟萃分析,以比较直接口服抗凝剂(DOACs)与维生素 K 拮抗剂(VKAs)在 AF 患者行电复律时的安全性和疗效。
我们在 CENTRAL、MEDLINE 和 EMBASE 中检索了比较 DOACs 与 VKAs 在 AF 患者行电复律时的随机对照试验(RCTs)和观察性研究。我们独立地进行了标题、摘要和全文筛选、数据提取和偏倚风险评估,并进行了重复评估。我们使用随机效应模型汇总数据,并使用 Grading of Recommendations Assessment, Development and Evaluation 评估总体证据质量。
我们确定了三项合格的 RCTs(n=5203)和 21 项观察性研究(n=11855)。三项 RCT 和四项观察性研究的偏倚风险较低。在 RCTs 中(平均随访 30 天),接受 DOACs 的患者中有 0.18%发生血栓栓塞事件,而接受 VKAs 的患者中有 0.55%(相对风险 [RR] 0.40,95%置信区间 [0.13,1.24],中等质量)。接受 DOACs 的患者中有 0.42%发生大出血,而接受 VKAs 的患者中有 0.64%(RR 0.62,95%置信区间 [0.28,1.35],中等质量),接受 DOACs 的患者中有 0.28%死亡,而接受 VKAs 的患者中有 0.38%(RR 0.70,95%置信区间 [0.23,2.10],低质量)。对观察性研究结果的置信度非常低。
在 AF 患者中行电复律时,DOACs 在出血和血栓栓塞风险方面似乎是安全的。现有证据支持在 AF 患者中行电复律时使用 DOACs 作为标准治疗。