Study compares strategies to save heart failure, atrial fibrillation patients

　　奥兰多11月6日，在2007AHA科学分会上公布了一项突破性临床试验的最终结果，此项研究旨在检测合并房颤的心衰患者，维持正常心律或仅控制心率是否可以有效降低心血管死亡风险。

　　房颤和心力衰竭（AF-CHF）试验，是一项前瞻性、随机、多中心临床试验，入选来自加拿大、美国、巴西、阿根廷、欧洲、以色列123个中心的1376名患者。

　　房颤是最常见的心律失常，是心脏上部结构——心房发生电活动紊乱。世界上有千百万人患有此病，它增加心源性死亡，是卒中的主要原因之一。

　　心衰是一种严重的心脏疾患，美国有500万心衰患者，每年约550,000人初次诊断出患有心衰。

　　在这项研究中，患者被随机分为节律控制组和心率控制组。节律控制组采用电复律联合抗心律失常药物，首选胺碘酮，特殊病例中服用盐酸索他洛尔或多非利特。心率控制组患者给与滴定剂量的β阻滞剂和地高辛，如需要则进行起搏器治疗。两组都给与优化心衰治疗和抗凝药物。

　　对病人进行平均37个月随访。节律与心率控制组患者心血管死亡（26.7%和25.2%）、总死亡率（31.8%和32.9%）、脑卒中（2.6%和3.6%）和心衰恶化性事件（27.6%对30.8%）均无显著差异。

　　研究的主要负责人，加拿大魁北克蒙特利尔大学医学系主任Denis Roy, M.D 教授说：“对合并房颤的心衰患者，与心率控制相比，节律控制没有改善预后。试验结果不提倡心衰合并房颤患者进行节律控制治疗。”

　　这项研究由加拿大健康研究机构支持。 

Study compares strategies to save heart failure, atrial fibrillation patients

ORLANDO, Nov. 6 – Final results were presented from a study to determine whether cardiovascular mortality can most effectively be reduced by trying to maintain a normal heart rhythm or by simply controlling the heart rate in people with both heart failure (HF) and atrial fibrillation during the late-breaking clinical trials presented at the American Heart Association’s Scientific Sessions 2007.

The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is a prospective, randomized, multicenter clinical trial with 1,376 patients at 123 sites in Canada, the United States, Brazil, Argentina, Europe, and Israel.     

Atrial fibrillation is the most common cardiac arrhythmia, with disorganized electrical activity in the atria, the upper chambers of the heart.Afflicting tens of millions of people worldwide, it is associated with increased risk of death from heart disease and is a major cause of stroke.

HF is a serious heart condition affecting over five million people in the United States.Each year, about 550,000 people are diagnosed for the first time.

In this study, patients randomized to the heart rhythm control group underwent electrical cardioversion combined with antiarrhymic drug therapy, using amiodarone as the initial drug of choice, with sotalol or dofetilide in specific cases.In the heart rate control group, patients received titrated doses of beta-blockers and digoxin or both and pacemaker therapy if needed.  Both groups received optimal heart failure management and anticoagulation.

Patients were followed for an average of 37 months.Cardiovascular death (the primary endpoint of the trial) occurred in 26.7 percent of patients in the rhythm-control　group compared to 25.2 percent of patients in the rate-control group (p=0.59).Total mortality (31.8 percent vs. 32.9 percent), strokes (2.6 percent vs. 3.6 percent) and worsening HF events (27.6 percent vs. 30.8 percent) were also similar between the rhythm-control versus the rate-control group.   

“We found that rhythm control does not improve mortality when compared to rate control,” said Denis Roy, M.D., principal investigator and professor and chair in the department of medicine at the University of Montreal, Quebec, Canada.“The results of the trial do not suggest that a strategy of rhythm control should be advocated for patients with atrial fibrillation and congestive heart failure.”

Support for this study was provided by the Canadian Institutes of Health Research.