降脂治疗对轻中度主动脉瓣狭窄进展的影响:2344 例随机安慰剂对照临床试验的荟萃分析。

Lipid lowering on progression of mild to moderate aortic stenosis: meta-analysis of the randomized placebo-controlled clinical trials on 2344 patients.

机构信息

Population Health Research Institute, McMaster University, and Hamilton General Hospital, Hamilton, Ontario, Canada.

出版信息

Can J Cardiol. 2011 Nov-Dec;27(6):800-8. doi: 10.1016/j.cjca.2011.03.012. Epub 2011 Jul 13.

Abstract

BACKGROUND

Aortic stenosis (AS) is believed to develop through an inflammatory similar to the atherosclerosis process. Based on findings from animal studies and uncontrolled clinical studies, lipid-lowering therapy with a statin is postulated to slow this process. Randomized trials, however, reported neutral results. This meta-analysis of randomized lipid trials on patients with AS examined the effects of treatment on AS progression and clinical outcomes.

METHODS

Echocardiographic measures of AS (aortic valve jet velocity, peak and mean valve gradients, and aortic valve area) were pooled and clinical outcomes were evaluated in 4 randomized placebo controlled trials (N=2344).

RESULTS

Although active treatment with statin therapy was associated with highly significant 50% reduction in low-density lipoprotein cholesterol levels, there were no statistical differences between active and placebo groups in any of the echocardiographic indicators of AS severity: annual increase in AS velocity was 0.16±0.28 m/sec, and mean gradient was 2.8±3.0 mm Hg. Each trial reported no differences in clinical outcomes between the 2 treatment groups. Substantial events rates (6.6% aortic valve surgery and 1.2% cardiovascular deaths per year in SEAS with follow-up of 4.4 years and 5.8% aortic valve surgery and 0.7% cardiovascular deaths per year in ASTRONOMER over 3.5 years) were observed in these patients despite the relatively mild disease.

CONCLUSION

The current data do not support the hypothesis that statin therapy reduces AS progression. Patients with mild to moderate AS may require closer follow-up because despite the less severe disease in these trials, event rates remain substantial.

摘要

背景

据信,主动脉瓣狭窄(AS)的发生是通过类似于动脉粥样硬化过程的炎症反应。基于动物研究和非对照临床研究的结果,推测降脂治疗中的他汀类药物可以减缓这一过程。然而,随机试验报告结果为中性。本项对患有 AS 的患者进行的随机脂质试验的荟萃分析检查了治疗对 AS 进展和临床结局的影响。

方法

对 4 项随机安慰剂对照试验(N=2344)中的 AS 超声心动图指标(主动脉瓣射流速度、峰值和平均瓣口梯度及主动脉瓣口面积)进行汇总,并评估临床结局。

结果

尽管他汀类药物活性治疗可使 LDL 胆固醇水平显著降低 50%,但在 AS 严重程度的任何超声心动图指标方面,活性治疗组与安慰剂组之间均无统计学差异:AS 速度的年增长率为 0.16±0.28 m/sec,平均梯度为 2.8±3.0 mm Hg。每个试验均报告 2 个治疗组之间的临床结局无差异。尽管疾病相对较轻,但这些患者的主要事件发生率(SEAS 随访 4.4 年的主动脉瓣手术率为 6.6%,心血管死亡率为 1.2%/年;ASTRONOMER 随访 3.5 年的主动脉瓣手术率为 5.8%,心血管死亡率为 0.7%/年)仍较高。

结论

目前的数据不支持他汀类药物治疗可减少 AS 进展的假说。轻度至中度 AS 患者可能需要更密切的随访,因为尽管这些试验中的疾病较轻,但事件发生率仍然较高。

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