Roy Denis, Talajic Mario, Nattel Stanley, Wyse D George, Dorian Paul, Lee Kerry L, Bourassa Martial G, Arnold J Malcolm O, Buxton Alfred E, Camm A John, Connolly Stuart J, Dubuc Marc, Ducharme Anique, Guerra Peter G, Hohnloser Stefan H, Lambert Jean, Le Heuzey Jean-Yves, O'Hara Gilles, Pedersen Ole Dyg, Rouleau Jean-Lucien, Singh Bramah N, Stevenson Lynne Warner, Stevenson William G, Thibault Bernard, Waldo Albert L
Montreal Heart Institute and the Université de Montréal, Montreal, QC H1T 1C8, Canada.
N Engl J Med. 2008 Jun 19;358(25):2667-77. doi: 10.1056/NEJMoa0708789.
It is common practice to restore and maintain sinus rhythm in patients with atrial fibrillation and heart failure. This approach is based in part on data indicating that atrial fibrillation is a predictor of death in patients with heart failure and suggesting that the suppression of atrial fibrillation may favorably affect the outcome. However, the benefits and risks of this approach have not been adequately studied.
We conducted a multicenter, randomized trial comparing the maintenance of sinus rhythm (rhythm control) with control of the ventricular rate (rate control) in patients with a left ventricular ejection fraction of 35% or less, symptoms of congestive heart failure, and a history of atrial fibrillation. The primary outcome was the time to death from cardiovascular causes.
A total of 1376 patients were enrolled (682 in the rhythm-control group and 694 in the rate-control group) and were followed for a mean of 37 months. Of these patients, 182 (27%) in the rhythm-control group died from cardiovascular causes, as compared with 175 (25%) in the rate-control group (hazard ratio in the rhythm-control group, 1.06; 95% confidence interval, 0.86 to 1.30; P=0.59 by the log-rank test). Secondary outcomes were similar in the two groups, including death from any cause (32% in the rhythm-control group and 33% in the rate-control group), stroke (3% and 4%, respectively), worsening heart failure (28% and 31%), and the composite of death from cardiovascular causes, stroke, or worsening heart failure (43% and 46%). There were also no significant differences favoring either strategy in any predefined subgroup.
In patients with atrial fibrillation and congestive heart failure, a routine strategy of rhythm control does not reduce the rate of death from cardiovascular causes, as compared with a rate-control strategy. (ClinicalTrials.gov number, NCT00597077.)
恢复并维持心房颤动合并心力衰竭患者的窦性心律是常见的治疗方法。这种方法部分基于一些数据，这些数据表明心房颤动是心力衰竭患者死亡的一个预测因素，并提示抑制心房颤动可能对预后产生有利影响。然而，这种方法的益处和风险尚未得到充分研究。
我们进行了一项多中心随机试验，比较左心室射血分数为35%或更低、有充血性心力衰竭症状且有心房颤动病史的患者维持窦性心律（节律控制）与控制心室率（率控制）的效果。主要结局是心血管原因导致的死亡时间。
共纳入1376例患者（节律控制组682例，率控制组694例），平均随访37个月。在这些患者中，节律控制组有182例（27%）死于心血管原因，而率控制组为175例（25%）（节律控制组的风险比为1.06；95%置信区间为0.86至1.30；对数秩检验P=0.59）。两组的次要结局相似，包括任何原因导致的死亡（节律控制组为32%，率控制组为33%）、中风（分别为3%和4%）、心力衰竭恶化（28%和31%）以及心血管原因导致的死亡、中风或心力衰竭恶化的复合结局（43%和46%）。在任何预先定义的亚组中，也没有显著差异支持任何一种策略。
对于心房颤动合并充血性心力衰竭的患者，与率控制策略相比，常规的节律控制策略并不能降低心血管原因导致的死亡率。（临床试验注册号：NCT00597077）
