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
TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Ave, First Floor, Boston, MA 02115, USA.
JAMA. 2008 Jul 2;300(1):71-80. doi: 10.1001/jama.300.1.71.
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.
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.
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.
Randomized clinical trials comparing an invasive vs conservative treatment strategy in patients with NSTE ACS.
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 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).
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.
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。
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。
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。
比较NSTE ACS患者侵入性与保守性治疗策略的随机临床试验。
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。
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)。
在NSTE ACS中