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厄贝沙坦对熊本地区房颤复发影响的研究:房颤抑制试验(SILK研究)。

Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto: Atrial Fibrillation Suppression Trial (SILK study).

作者信息

Yamabe Hiroshige, Kaikita Koichi, Matsumura Toshiyuki, Iwasa Atsushi, Koyama Junjiro, Uemura Takashi, Morikami Yasuhiro, Tsunoda Ryusuke, Morihisa Kenji, Fujimoto Kazuteru, Kajiwara Ichiro, Matsui Kunihiko, Tsujita Kenichi, Ogawa Hisao

机构信息

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Kumamoto, Japan.

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Kumamoto, Japan.

出版信息

J Cardiol. 2018 Feb;71(2):129-134. doi: 10.1016/j.jjcc.2017.07.010. Epub 2017 Sep 5.

Abstract

BACKGROUND

Experimental studies suggest that angiotensin II-receptor blockers can influence atrial remodeling and may prevent atrial fibrillation (AF). Therefore, we hypothesized that irbesartan may prevent the recurrence of AF following either catheter ablation or electrical cardioversion of AF.

METHODS

Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto (SILK study) is a prospective, multicenter, randomized, and open-label comparative evaluation of the effects of irbesartan and amlodipine on AF recurrence in hypertensive patients with AF who are scheduled to undergo catheter ablation or electrical cardioversion of AF. The primary end point was either AF or atrial tachycardia (AT) recurrence. AF/AT recurrence was evaluated for 6 months using 24-h Holter electrocardiogram and portable electrocardiogram. The secondary endpoints included the change in blood pressure, the interval from the procedure to the first AF/AT recurrence, cardiovascular events, left atrial diameter (LAD), left ventricular ejection fraction (LVEF), and changes in the biomarkers [brain natriuretic polypeptide (BNP), high-sensitivity C-reactive protein (hs-CRP), urinary albumin/creatinine].

RESULTS

The study enrolled 98 patients (irbesartan; n=47, amlodipine; n=51). The recurrence of AF/AT was observed in 8 patients (17.0%) in the irbesartan group and in 10 patients (19.6%) in the amlodipine group. There was no significant difference in the AF/AT recurrence between the irbesartan and amlodipine groups. Blood pressure decreased similarly in both groups. There were no significant differences between the two groups as regards to the interval from the procedure to the first AF/AT recurrence, occurrence of cardiovascular events, changes in LAD and LVEF. BNP and urinary albumin/creatinine significantly decreased similarly in both groups, but no significant difference was found in hs-CRP between the two groups.

CONCLUSIONS

In hypertensive patients with AF, treatment with irbesartan did not have any advantage over amlodipine in the reduction of AF/AT recurrence after catheter ablation or electrical cardioversion.

摘要

背景

实验研究表明,血管紧张素II受体阻滞剂可影响心房重构,并可能预防心房颤动(房颤)。因此,我们推测厄贝沙坦可能预防房颤导管消融或电复律后房颤的复发。

方法

熊本厄贝沙坦对房颤复发影响的研究(SILK研究)是一项前瞻性、多中心、随机、开放标签的比较评估,比较厄贝沙坦和氨氯地平对计划接受房颤导管消融或电复律的高血压房颤患者房颤复发的影响。主要终点是房颤或房性心动过速(房速)复发。使用24小时动态心电图和便携式心电图对房颤/房速复发进行6个月的评估。次要终点包括血压变化、从手术到首次房颤/房速复发的间隔时间、心血管事件、左心房直径(LAD)、左心室射血分数(LVEF)以及生物标志物[脑钠肽(BNP)、高敏C反应蛋白(hs-CRP)、尿白蛋白/肌酐]的变化。

结果

该研究纳入了98例患者(厄贝沙坦组;n = 47,氨氯地平组;n = 51)。厄贝沙坦组有8例患者(17.0%)出现房颤/房速复发,氨氯地平组有10例患者(19.6%)出现复发。厄贝沙坦组和氨氯地平组之间的房颤/房速复发无显著差异。两组血压下降情况相似。两组在从手术到首次房颤/房速复发的间隔时间、心血管事件的发生、LAD和LVEF的变化方面无显著差异。两组的BNP和尿白蛋白/肌酐均显著下降且相似,但两组之间hs-CRP无显著差异。

结论

在高血压房颤患者中,导管消融或电复律后,厄贝沙坦治疗在降低房颤/房速复发方面并不比氨氯地平有任何优势。

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