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不停用 vs. 中断围手术期直接口服抗凝剂用于心房颤动导管消融:一项关于消融后血栓栓塞和出血事件的前瞻性随机单中心研究。

Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events.

机构信息

Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.

Division of Radiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.

出版信息

Europace. 2019 Feb 1;21(2):259-267. doi: 10.1093/europace/euy148.

Abstract

AIMS

This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF).

METHODS AND RESULTS

We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428).

CONCLUSION

Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.

摘要

目的

本前瞻性、随机、单中心研究旨在直接比较非瓣膜性心房颤动(NVAF)患者行导管消融术前行抗凝治疗时,直接口服抗凝剂(DOAC)连续抗凝与间断抗凝方案的安全性和有效性。

方法和结果

我们将 846 例术前接受 DOAC 治疗的 NVAF 患者随机分为消融日不停用(n=422)或中断(n=424)DOAC 两组。主要终点为消融后 30 天内症状性血栓栓塞和大出血事件的复合终点。次要终点包括症状性和无症状性血栓栓塞以及大出血和小出血事件。不停用 DOAC 组的主要终点发生率为 0.7%(1 例短暂性脑缺血发作(TIA)和 2 例大出血事件),中断 DOAC 组为 1.2%(1 例 TIA 和 4 例大出血事件)(P=0.480)。两组大出血和小出血发生率相当(0.5% vs. 0.9%,P=0.345;5.9% vs. 5.4%,P=0.753)。661 例行消融后磁共振(MR)成像的患者中,观察到 138 例(20.9%)有无症状性脑缺血性病变(SCILs)。不停用和中断 DOAC 组的 SCIL 发生率相似(19.8% vs. 22.0%,P=0.484),随访 MR 成像上 SCIL 消失的比例也相似(77.8% vs. 82.1%,P=0.428)。

结论

不停用和中断 DOAC 方案均显示出低风险的症状性血栓栓塞和大出血事件,以及相似的 SCIL 发生率和小出血事件发生率,对于行导管消融术的 NVAF 患者,围手术期抗凝治疗可能是可行的。

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