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复发性持续性心房颤动患者心率控制与节律控制的比较。

A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation.

作者信息

Van Gelder Isabelle C, Hagens Vincent E, Bosker Hans A, Kingma J Herre, Kamp Otto, Kingma Tsjerk, Said Salah A, Darmanata Julius I, Timmermans Alphons J M, Tijssen Jan G P, Crijns Harry J G M

机构信息

Department of Cardiology, Thoraxcenter, University Hospital, Groningen, The Netherlands.

出版信息

N Engl J Med. 2002 Dec 5;347(23):1834-40. doi: 10.1056/NEJMoa021375.

Abstract

BACKGROUND

Maintenance of sinus rhythm is the main therapeutic goal in patients with atrial fibrillation. However, recurrences of atrial fibrillation and side effects of antiarrhythmic drugs offset the benefits of sinus rhythm. We hypothesized that ventricular rate control is not inferior to the maintenance of sinus rhythm for the treatment of atrial fibrillation.

METHODS

We randomly assigned 522 patients who had persistent atrial fibrillation after a previous electrical cardioversion to receive treatment aimed at rate control or rhythm control. Patients in the rate-control group received oral anticoagulant drugs and rate-slowing medication. Patients in the rhythm-control group underwent serial cardioversions and received antiarrhythmic drugs and oral anticoagulant drugs. The end point was a composite of death from cardiovascular causes, heart failure, thromboembolic complications, bleeding, implantation of a pacemaker, and severe adverse effects of drugs.

RESULTS

After a mean (+/-SD) of 2.3+/-0.6 years, 39 percent of the 266 patients in the rhythm-control group had sinus rhythm, as compared with 10 percent of the 256 patients in the rate-control group. The primary end point occurred in 44 patients (17.2 percent) in the rate-control group and in 60 (22.6 percent) in the rhythm-control group. The 90 percent (two-sided) upper boundary of the absolute difference in the primary end point was 0.4 percent (the prespecified criterion for noninferiority was 10 percent or less). The distribution of the various components of the primary end point was similar in the rate-control and rhythm-control groups.

CONCLUSIONS

Rate control is not inferior to rhythm control for the prevention of death and morbidity from cardiovascular causes and may be appropriate therapy in patients with a recurrence of persistent atrial fibrillation after electrical cardioversion.

摘要

背景

维持窦性心律是心房颤动患者的主要治疗目标。然而,心房颤动的复发以及抗心律失常药物的副作用抵消了窦性心律带来的益处。我们假设,在心房颤动的治疗中,心室率控制并不劣于窦性心律的维持。

方法

我们将522例在先前电复律后发生持续性心房颤动的患者随机分组,分别接受旨在控制心率或控制心律的治疗。心率控制组的患者接受口服抗凝药物和减慢心率的药物治疗。心律控制组的患者接受系列电复律,并接受抗心律失常药物和口服抗凝药物治疗。终点为心血管原因导致的死亡、心力衰竭、血栓栓塞并发症、出血、起搏器植入以及药物的严重不良反应的综合情况。

结果

平均(±标准差)2.3±0.6年后,心律控制组的266例患者中有39%维持窦性心律,而心率控制组的256例患者中这一比例为10%。心率控制组有44例患者(17.2%)达到主要终点,心律控制组有60例患者(22.6%)达到主要终点。主要终点绝对差异的90%(双侧)上界为0.4%(预先设定的非劣效性标准为10%或更低)。心率控制组和心律控制组主要终点各组成部分的分布相似。

结论

在预防心血管原因导致的死亡和发病方面,心率控制并不劣于心律控制,对于电复律后持续性心房颤动复发的患者,心率控制可能是合适的治疗方法。

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