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非 ST 段抬高型急性冠状动脉综合征经皮冠状动脉介入治疗患者的缺血和出血结局的性别差异:来自 TAO 试验的见解。

Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial.

机构信息

Université de Paris, Hôpital Lariboisière, AP-HP, Inserm U-942, Paris, France (J.-G.D., P.H.).

Université de Paris, AP-HP, FACT, FHU APOLLO, Hôpital Bichat, Inserm U-1148, Paris, France (G.D., Y.E., P.G.S.).

出版信息

Circ Cardiovasc Interv. 2021 Jan;14(1):e009759. doi: 10.1161/CIRCINTERVENTIONS.120.009759. Epub 2021 Jan 12.

DOI:10.1161/CIRCINTERVENTIONS.120.009759
PMID:33430604
Abstract

BACKGROUND

Previous studies have observed poorer outcomes in females with myocardial infarction, but older age and lower use of percutaneous coronary intervention in females are factors that potentially explain the worse outcome. This study sought to determine if female sex is an independent factor of ischemic and bleeding outcomes in non-ST-segment-elevation acute coronary syndrome treated with a systematic invasive approach.

METHODS

The TAO trial (Treatment of Acute Coronary Syndrome With Otamixaban) randomized patients with non-ST-segment-elevation acute coronary syndrome treated invasively to heparin plus eptifibatide versus otamixaban. In this post hoc analysis, the primary ischemic end point (all-cause death, myocardial infarction within 180 days) and the primary safety end point (Thrombolysis in Myocardial Infarction major or minor bleeding within 30 days) were analyzed according to sex.

RESULTS

Of 13 229 randomized patients, 3980 (30.1%) were females and 9249 (69.9%) were males. Females were older (64.8±11.0 versus 60.7±11.1 years), had more comorbidities, received less peri-procedural antithrombotic therapy, and underwent less frequently revascularization. Overall, females experienced a higher risk of ischemic (10.2% versus 9.1%; odds ratio [OR], 1.15 [1.01-1.30]) and bleeding events (4.2% versus 3.4%; OR, 1.23 [1.02-1.49]) than males. After multivariate analysis, the risk of ischemic outcomes (OR, 1.04 [0.90-1.19]), death (OR, 1.00 [0.75-1.23]), or bleeding (OR, 1.05 [0.85-1.28]), were similar between females and males. Only, noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding were increased in females (OR, 1.69 [1.11-2.56]).

CONCLUSIONS

In patients with non-ST-segment-elevation acute coronary syndrome with systematic invasive management, ischemic outcomes, bleeding events, and mortality were higher in females. After multivariate analyses, female sex was not an independent predictor of ischemic and bleeding events although noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding was higher in females. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01076764.

摘要

背景

先前的研究观察到女性心肌梗死的预后较差,但年龄较大和女性接受经皮冠状动脉介入治疗的比例较低是导致预后较差的潜在因素。本研究旨在确定在接受系统介入治疗的非 ST 段抬高型急性冠状动脉综合征患者中,女性性别是否为缺血和出血结局的独立因素。

方法

TAO 试验(奥米加替班治疗急性冠状动脉综合征)将接受非 ST 段抬高型急性冠状动脉综合征介入治疗的患者随机分为肝素加依替巴肽组与奥米加替班组。在本事后分析中,根据性别分析主要缺血终点(全因死亡、180 天内心肌梗死)和主要安全性终点(30 天内血栓溶栓治疗心肌梗死大出血或小出血)。

结果

在 13229 名随机患者中,3980 名(30.1%)为女性,9249 名(69.9%)为男性。女性年龄较大(64.8±11.0 岁比 60.7±11.1 岁),合并症较多,接受的围手术期抗血栓治疗较少,且血运重建的频率较低。总体而言,女性发生缺血性(10.2%比 9.1%;比值比[OR],1.15[1.01-1.30])和出血事件(4.2%比 3.4%;OR,1.23[1.02-1.49])的风险高于男性。多变量分析后,女性的缺血性结局风险(OR,1.04[0.90-1.19])、死亡风险(OR,1.00[0.75-1.23])或出血风险(OR,1.05[0.85-1.28])与男性相似。仅女性非冠状动脉旁路移植术相关血栓溶栓治疗心肌梗死大出血的风险增加(OR,1.69[1.11-2.56])。

结论

在接受系统介入治疗的非 ST 段抬高型急性冠状动脉综合征患者中,女性的缺血性结局、出血事件和死亡率较高。多变量分析后,女性性别不是缺血和出血事件的独立预测因素,但女性非冠状动脉旁路移植术相关血栓溶栓治疗心肌梗死大出血的风险较高。

注册信息

网址:https://www.clinicaltrials.gov。唯一标识符:NCT01076764。

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