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两种直接口服抗凝剂用于接受心脏消融术患者的随机对照研究,并设当代华法林对照组。

A randomized comparison of two direct oral anticoagulants for patients undergoing cardiac ablation with a contemporary warfarin control arm.

作者信息

Yoshimoto Issei, Iriki Yasuhisa, Oketani Naoya, Okui Hideki, Ichiki Hitoshi, Maenosono Ryuichi, Namino Fuminori, Miyata Masaaki, Ohishi Mitsuru

机构信息

Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.

Clinical Laboratory Unit, Kagoshima University Hospital, Kagoshima, Japan.

出版信息

J Interv Card Electrophysiol. 2021 Apr;60(3):375-385. doi: 10.1007/s10840-020-00732-y. Epub 2020 Apr 21.

DOI:10.1007/s10840-020-00732-y
PMID:32318963
Abstract

BACKGROUND

The safety and efficacy of periprocedural use of direct oral anticoagulants (DOACs) for atrial fibrillation (AF) remain unclear. We compared the incidence of asymptomatic cerebral micro-thromboembolism and hemopericardium following AF ablation among patients receiving edoxaban, rivaroxaban, and warfarin and between normal- and low-dose use of edoxaban and rivaroxaban.

METHODS

This prospective randomized study included 170 consecutive AF patients. Patients taking DOACs upon admission to our hospital were randomly assigned to an edoxaban group or to a rivaroxaban group. Warfarin was continued in patients receiving warfarin at admission. All patients underwent AF ablation, and cerebral MRI was performed to evaluate asymptomatic cerebral micro-thromboembolism the day after the procedure.

RESULTS

Sixty-one patients were assigned to edoxaban and 63 to rivaroxaban. Warfarin was continued in 46 patients. Although asymptomatic cerebral micro-thromboembolism was detected in 25 patients (16.3%), there were no significant differences among the groups. Hemopericardium occurred in 2 patients (one each in the rivaroxaban and warfarin groups). The incidence of asymptomatic cerebral micro-thromboembolism was higher in the low-dose group (9 patients, 25.7%) than in the normal-dose group (8 patients, 10.0%) for patients prescribed either edoxaban or rivaroxaban (p < 0.05). The proportion of males (88.0%, 69.5%, p < 0.05), history of prior AF ablation (64.0%, 42.2%, p < 0.05), and hypertension (68.0%, 46.1%, p < 0.05) were significantly higher in patients with cerebral thromboembolism.

CONCLUSIONS

The incidence of asymptomatic cerebral micro-thromboembolism and hemopericardium in AF ablation was similar among patients using edoxaban, rivaroxaban, and warfarin. However, low doses of DOACs may increase the risk of asymptomatic stroke.

摘要

背景

直接口服抗凝剂(DOACs)用于心房颤动(AF)围手术期的安全性和有效性尚不清楚。我们比较了接受依度沙班、利伐沙班和华法林治疗的患者以及依度沙班和利伐沙班正常剂量与低剂量使用情况下AF消融术后无症状脑微血栓形成和心包积血的发生率。

方法

这项前瞻性随机研究纳入了170例连续的AF患者。入院时服用DOACs的患者被随机分配到依度沙班组或利伐沙班组。入院时接受华法林治疗的患者继续使用华法林。所有患者均接受AF消融术,并在术后第二天进行脑部MRI检查以评估无症状脑微血栓形成情况。

结果

61例患者被分配到依度沙班组,63例被分配到利伐沙班组。46例患者继续使用华法林。尽管在25例患者(16.3%)中检测到无症状脑微血栓形成,但各治疗组之间无显著差异。2例患者发生心包积血(利伐沙班组和华法林组各1例)。对于服用依度沙班或利伐沙班的患者,低剂量组(9例患者,25.7%)无症状脑微血栓形成的发生率高于正常剂量组(8例患者,10.0%)(p<0.05)。脑微血栓形成患者中男性比例(88.0%、69.5%,p<0.05)、既往AF消融病史(64.0%、42.2%,p<0.05)和高血压(68.0%、46.1%,p<0.05)显著更高。

结论

使用依度沙班、利伐沙班和华法林的患者在AF消融术中无症状脑微血栓形成和心包积血的发生率相似。然而,低剂量DOACs可能会增加无症状性卒中的风险。

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引用本文的文献

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J Clin Med. 2022 Mar 28;11(7):1872. doi: 10.3390/jcm11071872.
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Cochrane Database Syst Rev. 2021 Oct 21;10(10):CD013504. doi: 10.1002/14651858.CD013504.pub2.