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左心耳封堵术后高出血风险患者简化或常规抗栓治疗方案的比较:PLATEBRISK 研究。

A comparison of simplified or conventional antithrombotic regimens after left atrial appendage closure in patients at high bleeding risk: the PLATEBRISK study.

机构信息

Hospital Clinico Universitario de Salamanca, CIBERCV, IBSAL, Salamanca, Spain.

Servicio de Cardiología, Instituto Clínic Cardiovascular, Hospital Clínic, Barcelona, Spain.

出版信息

EuroIntervention. 2024 Aug 19;20(16):1018-1028. doi: 10.4244/EIJ-D-24-00116.

Abstract

BACKGROUND

Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk.

AIMS

This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients.

METHODS

This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy).

RESULTS

A total of 1,135 patients were included. The mean CHADS-VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049).

CONCLUSIONS

In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.

摘要

背景

左心耳封堵(LAAO)术后抗栓治疗(ATT)仍存在争议。此外,大多数接受 LAAO 的患者存在极高的出血风险。

目的

本研究旨在比较极高出血风险患者 LAAO 后简化与常规 ATT。

方法

这是一项多中心回顾性研究,纳入极高出血风险患者,根据出血学术研究联盟(BARC)定义,这些患者在术后发生 BARC 3-5 级出血的风险>4%或发生颅内出血的风险>1%。根据出院时的 ATT 将患者分为两组。简化组包括单一抗血小板治疗或不治疗,常规组包括双联抗血小板治疗或抗凝(联合或不联合抗血小板治疗)。

结果

共纳入 1135 例患者。平均 CHADS-VASc 和 HAS-BLED 评分分别为 4.5±1.5 和 3.7±1.0。两组复合终点(死亡、卒、短暂性脑缺血发作、器械相关血栓或大出血)无差异(风险比[HR]0.81,95%置信区间[CI]:0.59-1.11;p=0.188)。尽管简化组第一年大出血发生率较低,但未达到统计学意义(HR 0.67,95%CI:0.41-1.10;p=0.104)。然而,有既往大出血史的患者使用简化治疗时大出血发生率显著降低(HR 0.61,95%CI:0.36-0.99;p=0.049)。

结论

在极高出血风险患者中,LAAO 后简化 ATT 似乎与常规方案同样有效。此外,有既往大出血史的患者使用简化 ATT 时大出血风险降低。

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