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一项评估降低胆固醇对主动脉瓣狭窄进展影响的随机试验的原理、设计和基线特征:主动脉瓣狭窄进展观察:瑞舒伐他汀疗效评估(ASTRONOMER)试验

Rationale, design, and baseline characteristics of a randomized trial to assess the effect of cholesterol lowering on the progression of aortic stenosis: the Aortic Stenosis Progression Observation: Measuring Effects of Rosuvastatin (ASTRONOMER) trial.

作者信息

Chan Kwan-Leung, Teo Koon, Tam James, Dumesnil Jean G

机构信息

Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

出版信息

Am Heart J. 2007 Jun;153(6):925-31. doi: 10.1016/j.ahj.2007.03.011.

Abstract

BACKGROUND

Aortic stenosis (AS) is a common health problem in the western world. Recent studies have suggested that cholesterol lowering may have a salutary effect on the progression of AS. The primary objective of the ASTRONOMER study is to determine whether patients with AS randomized to rosuvastatin will experience less progression in AS severity as measured by aortic transvalvular gradients and valve areas. The secondary objectives are to determine the effect of rosuvastatin on the rate of cardiac death and aortic valve replacement and to assess the time to outcome during a follow-up of 3 to 5 years.

METHOD

This is a double-blind placebo-controlled study. Patients with mild to moderate AS are randomized to receive 40 mg/d of rosuvastatin or placebo. Patients with any clinical indication for the use of cholesterol-lowering agents according to the 2000 Canadian guidelines are excluded.

RESULTS

Recruitment of 272 patients from 23 Canadian sites was completed in December 2005. Compared with patients with AS in published trials, the patients in the ASTRONOMER study are younger (58.1 +/- 13.6 years), have less severe AS (AS jet velocity 3.2 +/- 0.4 m/s), and are composed of a great proportion (48.9%) of patients with bicuspid aortic valve.

CONCLUSIONS

Prevention of the development of severe AS needs to be tested in large randomized studies. Recruitment for the ASTRONOMER trial has been completed and results will be available at the end of 2008.

摘要

背景

主动脉瓣狭窄(AS)是西方世界常见的健康问题。近期研究表明,降低胆固醇可能对AS的进展具有有益作用。ASTRONOMER研究的主要目的是确定随机接受瑞舒伐他汀治疗的AS患者,通过主动脉跨瓣压差和瓣膜面积测量的AS严重程度进展是否较小。次要目的是确定瑞舒伐他汀对心源性死亡和主动脉瓣置换率的影响,并评估3至5年随访期间达到结局的时间。

方法

这是一项双盲安慰剂对照研究。轻度至中度AS患者被随机分配接受40mg/d的瑞舒伐他汀或安慰剂。根据2000年加拿大指南有任何使用降胆固醇药物临床指征的患者被排除。

结果

2005年12月完成了从加拿大23个地点招募272名患者的工作。与已发表试验中的AS患者相比,ASTRONOMER研究中的患者更年轻(58.

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