Major European study of device therapy aimed at preventing permanent atrial fibrillation

　　奥兰多11月6日，AHA2007科学分会上最新临床试验公布的一项欧洲多国研究发现，心脏再同步（CRT）超速心房起搏对预防心力衰竭患者发生持续性房颤无效。

　　MASCOT是一项前瞻性、随机、对照研究，纳入意大利、法国、比利时、德国、希腊的中心的心衰患者394名，79%为男性，平均年龄为68岁。治疗组197名患者进行CRT联合心房驱动起搏（以高于病人本身的心房节律起搏），通过心室起搏来提高心脏功能。

　　研究的主要负责人，意大利佛洛伦萨大学心脏病研究生学院主任，心脏病学教授Luigi Padeletti M.D说：“这是第一项分析CRT预防心衰患者房颤进展的前瞻性随机研究。”

　　为期两年的研究第1年结果显示，心脏再同步化治疗是安全的，而且预期在严重心力衰竭患者是安全的，纽约心脏病分级III到IV级，左室射血分数时≤35%。但与对照组相比，治疗组并不能有效预防持续性房颤的发生。

　　治疗组有减少死亡率的趋势，治疗组死亡率是7.6%，对照组死亡率是11.7%，但是没有显著统计学差异。这项研究是由St Jude 医疗机构支持的。

Major European study of device therapy aimed at preventing permanent atrial fibrillation

ORLANDO, Nov. 6– A multinational European study found that using a cardiac resynchronization therapy (CRT) device to provide overdrive atrial pacing does not prevent patients with heart failure (HF) from developing permanent atrial fibrillation (AF).The results were presented in a late-breaking clinical trial session at the American Heart Association’s Scientific Sessions 2007.

MASCOT is a prospective, randomized, controlled trial of HF patients enrolled from centers in Italy, France, Belgium, Germany and Greece.The study population was 79 percent male, with a mean age of 68 years.There were 197 patients in the treatment arm and 197 patients in the control arm.The treatment arm added atrial overdrive pacing (pacing above the patient’s own atrial rate) to CRT, which uses ventricular pacing to improve heart function.

“This is the first prospective randomized study to analyze the effects of using a CRT device to prevent the development of AF in HF patients,” said Luigi Padeletti, M.D., the study’s principal investigator and professor of cardiology and director of the Postgraduate School of Cardiology, University of Florence, Italy.

The one-year results of the two-year study demonstrate the device is safe, and the programmed algorithm （算法）is safe in patients with serious heart failure, New York Heart Class III or IV, and a left ventricular ejection fraction of 35 percent or less.However, the study did not find any statistically significant difference between the development of permanent AF in the treated and control groups (3.3% in both).

Researchers found a trend toward reduced mortality in the treated versus control group, with 7.6 percent mortality in the treated group compared to 11.7 percent mortality in the control group, but the difference was not statistically significant.

Support for this study was provided by St Jude Medical.