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不稳定型心绞痛和非ST段抬高型心肌梗死患者中早期侵入性与保守治疗策略的比较:一项荟萃分析

Early invasive vs conservative treatment strategies in women and men with unstable angina and non-ST-segment elevation myocardial infarction: a meta-analysis.

作者信息

O'Donoghue Michelle, Boden William E, Braunwald Eugene, Cannon Christopher P, Clayton Tim C, de Winter Robbert J, Fox Keith A A, Lagerqvist Bo, McCullough Peter A, Murphy Sabina A, Spacek Rudolf, Swahn Eva, Wallentin Lars, Windhausen Fons, Sabatine Marc S

机构信息

TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Ave, First Floor, Boston, MA 02115, USA.

出版信息

JAMA. 2008 Jul 2;300(1):71-80. doi: 10.1001/jama.300.1.71.

Abstract

CONTEXT

Although an invasive strategy is frequently used in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS), data from some trials suggest that this strategy may not benefit women.

OBJECTIVE

To conduct a meta-analysis of randomized trials to compare the effects of an invasive vs conservative strategy in women and men with NSTE ACS.

DATA SOURCES

Trials were identified through a computerized literature search of the MEDLINE and Cochrane databases (1970-April 2008) using the search terms invasive strategy, conservative strategy, selective invasive strategy, acute coronary syndromes, non-ST-elevation myocardial infarction, and unstable angina.

STUDY SELECTION

Randomized clinical trials comparing an invasive vs conservative treatment strategy in patients with NSTE ACS.

DATA EXTRACTION

The principal investigators for each trial provided the sex-specific incidences of death, myocardial infarction (MI), and rehospitalization with ACS through 12 months of follow-up.

DATA SYNTHESIS

Data were combined across 8 trials (3075 women and 7075 men). The odds ratio (OR) for the composite of death, MI, or ACS for invasive vs conservative strategy in women was 0.81 (95% confidence interval [CI], 0.65-1.01; 21.1% vs 25.0%) and in men was 0.73 (95% CI, 0.55-0.98; 21.2% vs 26.3%) without significant heterogeneity between sexes (P for interaction = .26). Among biomarker-positive women, an invasive strategy was associated with a 33% lower odds of death, MI, or ACS (OR, 0.67; 95% CI, 0.50-0.88) and a nonsignificant 23% lower odds of death or MI (OR, 0.77; 95% CI, 0.47-1.25). In contrast, an invasive strategy was not associated with a significant reduction in the triple composite end point in biomarker-negative women (OR, 0.94; 95% CI, 0.61-1.44; P for interaction = .36) and was associated with a nonsignificant 35% higher odds of death or MI (OR, 1.35; 95% CI, 0.78-2.35; P for interaction = .08). Among men, the OR for death, MI, or ACS was 0.56 (95% CI, 0.46-0.67) if biomarker-positive and 0.72 (95% CI, 0.51-1.01) if biomarker-negative (P for interaction = .09).

CONCLUSIONS

In NSTE ACS, an invasive strategy has a comparable benefit in men and high-risk women for reducing the composite end point of death, MI, or rehospitalization with ACS. In contrast, our data provide evidence supporting the new guideline recommendation for a conservative strategy in low-risk women.

摘要

背景

尽管侵入性策略常用于非ST段抬高型急性冠脉综合征(NSTE ACS)患者,但一些试验数据表明该策略可能对女性无益处。

目的

对随机试验进行荟萃分析,比较侵入性与保守性策略对NSTE ACS女性和男性的影响。

数据来源

通过使用搜索词“侵入性策略”“保守性策略”“选择性侵入性策略”“急性冠脉综合征”“非ST段抬高型心肌梗死”和“不稳定型心绞痛”,对MEDLINE和Cochrane数据库(1970年至2008年4月)进行计算机文献检索来确定试验。

研究选择

比较NSTE ACS患者侵入性与保守性治疗策略的随机临床试验。

数据提取

每项试验的主要研究者提供了随访12个月期间按性别分类的死亡、心肌梗死(MI)和因ACS再次住院的发生率。

数据综合

汇总了8项试验(3075名女性和7075名男性)的数据。女性中侵入性与保守性策略相比,死亡、MI或ACS复合终点的比值比(OR)为0.81(95%置信区间[CI],0.65 - 1.01;21.1%对25.0%),男性为0.73(95% CI,0.55 - 0.98;21.2%对26.3%),性别间无显著异质性(交互作用P值 = 0.26)。在生物标志物阳性的女性中,侵入性策略与死亡、MI或ACS的OR降低33%相关(OR,0.67;95% CI,0.50 - 0.88),与死亡或MI的OR降低23%无显著相关性(OR,0.77;95% CI,0.47 - 1.25)。相比之下,侵入性策略与生物标志物阴性女性的三联复合终点显著降低无关(OR,0.94;95% CI,0.61 - 1.44;交互作用P值 = 0.36),且与死亡或MI的OR升高35%无显著相关性(OR,1.35;95% CI,0.78 - 2.35;交互作用P值 = 0.08)。在男性中,生物标志物阳性时死亡、MI或ACS的OR为0.56(95% CI,0.46 - 0.67),生物标志物阴性时为0.72(95% CI,0.51 - 1.01)(交互作用P值 = 0.09)。

结论

在NSTE ACS中

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