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心脏手术后心房颤动中直接口服抗凝剂:系统评价和荟萃分析与试验序贯分析。

Direct oral anticoagulants in atrial fibrillation following cardiac surgery: a systematic review and meta-analysis with trial sequential analysis.

机构信息

Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

Agency for Science, Technology and Research, Singapore.

出版信息

Br J Anaesth. 2022 Aug;129(2):154-162. doi: 10.1016/j.bja.2022.05.010. Epub 2022 Jun 18.

DOI:10.1016/j.bja.2022.05.010
PMID:35729010
Abstract

BACKGROUND

Direct oral anticoagulants (DOACs) have been increasingly used as anticoagulation therapy in the postoperative period. However, their effectiveness in post-cardiac surgical atrial fibrillation is yet to be determined.

METHODS

We conducted a meta-analysis, searching three international databases from 1 January 2003 to 26 January 2022 for studies reporting on DOACs in at least 10 adult patients (>18 yr of age) with post-cardiac surgical atrial fibrillation. The primary outcomes were major neurological events and bleeding; secondary outcomes were mortality, hospital and ICU length of stay, cost, and other complications from therapy. We included studies of any design, including RCTs, cohort studies with and without propensity score matching methods, and single-armed case series.

RESULTS

Twelve studies (8587 DOACs; 8315 warfarin) were included in this meta-analysis. The incidences of postoperative bleeding and major neurological events with DOACs were 7.3% (95% confidence interval [CI]: 3.4-14.7%) and 2.2% (95% CI: 0.9-4.9%), respectively. The incidence of major neurological events was lower in high-risk patients, including those with hypertension and higher CHADS-VASc score, whereas patients with prior transient ischaemic attack or stroke had higher incidence of bleeding. Trial sequential analysis revealed that the cumulative Z-curve crossed the conventional boundary of benefit. Compared with warfarin, DOACs reduced the risk of bleeding (relative risk [RR] 0.74; 95% CI: 0.62-0.89; P=0.0011) and major neurological events (RR 0.63; 95% CI: 0.48-0.83; P=0.0012) but not mortality (RR 1.02; 95% CI: 0.77-1.35; P=0.090).

CONCLUSIONS

DOACs reduced bleeding and major neurological events in patients with post-cardiac surgical atrial fibrillation, appearing safer than warfarin in this context. However, which specific DOAC provides the most effective anticoagulation in this patient population needs further investigation.

CLINICAL TRIAL REGISTRATION

PROSPERO CRD42021282777.

摘要

背景

直接口服抗凝剂(DOACs)已越来越多地被用作心脏手术后的抗凝治疗。然而,其在心脏手术后心房颤动中的有效性尚待确定。

方法

我们进行了一项荟萃分析,从 2003 年 1 月 1 日至 2022 年 1 月 26 日,在三个国际数据库中搜索了至少报告了 10 例成人(>18 岁)心脏手术后心房颤动患者使用 DOACs 的研究。主要结局为主要神经事件和出血;次要结局为死亡率、住院和 ICU 住院时间、成本和其他治疗并发症。我们纳入了任何设计的研究,包括 RCTs、有和没有倾向评分匹配方法的队列研究以及单臂病例系列研究。

结果

这项荟萃分析纳入了 12 项研究(8587 例 DOACs;8315 例华法林)。DOACs 术后出血和主要神经事件的发生率分别为 7.3%(95%置信区间[CI]:3.4-14.7%)和 2.2%(95% CI:0.9-4.9%)。在包括高血压和更高 CHADS-VASc 评分的高危患者中,主要神经事件的发生率较低,而既往短暂性脑缺血发作或中风的患者出血发生率较高。试验序贯分析显示,累积 Z 曲线越过了常规获益边界。与华法林相比,DOACs 降低了出血风险(相对风险[RR]0.74;95% CI:0.62-0.89;P=0.0011)和主要神经事件风险(RR 0.63;95% CI:0.48-0.83;P=0.0012),但不降低死亡率(RR 1.02;95% CI:0.77-1.35;P=0.090)。

结论

DOACs 降低了心脏手术后心房颤动患者的出血和主要神经事件风险,在这种情况下,其安全性似乎优于华法林。然而,哪种特定的 DOAC 在这一患者群体中提供最有效的抗凝治疗需要进一步研究。

临床试验注册

PROSPERO CRD42021282777。

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