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心房颤动消融术后抗凝治疗的长期疗效和安全性:来自JACRE注册研究的数据

Long-term efficacy and safety of anticoagulation after atrial fibrillation ablation: data from the JACRE registry.

作者信息

Inoue Koichi, Hirao Kenzo, Kumagai Koichiro, Kimura Masaomi, Miyauchi Yasushi, Tsushima Eiki, Ohishi Mitsuru, Kimura Kazumi, Yasaka Masahiro, Yamaji Hirosuke, Okawa Keisuke, Fujimoto Manabu, Morishima Itsuro, Mine Takanao, Shimizu Wataru, Ohe Masatsugu, Okumura Ken

机构信息

Cardiovascular Center, Sakurabashi Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.

Arrhythmia Advanced Therapy Center, AOI Universal Hospital, Kawasaki, Japan.

出版信息

J Cardiol. 2021 Mar;77(3):263-270. doi: 10.1016/j.jjcc.2020.09.001. Epub 2020 Oct 1.

Abstract

BACKGROUND

Catheter ablation (CA) is an important strategy for managing atrial fibrillation (AF). However, long-term anticoagulation strategies and clinical outcomes following CA, including thromboembolism and bleeding, have not yet been elucidated.

METHODS

We established a prospective registry, called the JACRE registry, for patients on rivaroxaban or warfarin administration who received CA for AF. The outcomes up to 30 days following the procedure were reported previously. The present study involved longer follow-up of patients enrolled in this registry to evaluate long-term anticoagulation strategies and clinical outcomes.

RESULTS

Data of 975 patients (rivaroxaban, n = 823; warfarin, n = 152) were collected from 27 institutes. Patient population had mean age 63.7 ± 10.3 years, 710 (72.8%) males, mean CHADS-VASc score 1.9 ± 1.5, and mean follow-up period 28.7 ± 12.7 months after the index procedure. Anticoagulants were continued in 496 (50.9%) patients during the follow-up. Thromboembolism occurred in 3 patients, hemorrhagic stroke in 5, and major bleeding events in 9 (annualized event rate, 0.13%, 0.22%, and 0.40% per patient-year, respectively). There were no differences in the composite event rate of thromboembolism and International Society on Thrombosis and Haemostasis major bleeding between rivaroxaban and warfarin cohorts (0.53% and 0.55% per patient-year, respectively).

CONCLUSIONS

Long-term incidence of thromboembolism was extremely low in patients with AF treated with CA, while that of major bleeding was not especially low. Clinical Trials Registry: UMIN000032829 / UMIN000032830.

摘要

背景

导管消融术(CA)是治疗心房颤动(AF)的重要策略。然而,CA术后的长期抗凝策略以及包括血栓栓塞和出血在内的临床结局尚未阐明。

方法

我们为接受AF导管消融术且正在服用利伐沙班或华法林的患者建立了一个前瞻性登记系统,称为JACRE登记系统。先前已报告了术后30天内的结局。本研究对该登记系统中的患者进行了更长时间的随访,以评估长期抗凝策略和临床结局。

结果

从27个机构收集了975例患者的数据(利伐沙班组,n = 823;华法林组,n = 152)。患者人群的平均年龄为63.7±10.3岁,男性710例(72.8%),平均CHADS-VASc评分为1.9±1.5,首次手术后的平均随访期为28.7±12.7个月。随访期间,496例(50.9%)患者继续使用抗凝剂。发生3例血栓栓塞,5例出血性卒中,9例发生大出血事件(年化事件发生率分别为每位患者每年0.13%、0.2%和0.40%)。利伐沙班组和华法林组之间血栓栓塞与国际血栓与止血学会大出血的复合事件发生率无差异(分别为每位患者每年0.53%和0.55%)。

结论

CA治疗的AF患者血栓栓塞的长期发生率极低,而大出血的发生率并非特别低。临床试验注册:UMIN000032829 / UMIN000032830。

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