ST段抬高型心肌梗死的全球结局：依诺肝素与急性心肌梗死溶栓再灌注治疗-心肌梗死溶栓试验25（ExTRACT-TIMI 25）注册研究与试验的比较

Global outcomes of ST-elevation myocardial infarction: comparisons of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25) registry and trial.

作者信息

Steinberg Benjamin A, Moghbeli Nazanin, Buros Jacqueline, Ruda Mikhail, Parkhomenko Alexander, Raju B Soma, García-Castillo Armando, Janion Marianna, Nicolau José C, Fox Keith A A, Morrow David A, Gibson C Michael, Antman Elliott M

机构信息

Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, MA 02115, USA.

出版信息

Am Heart J. 2007 Jul;154(1):54-61. doi: 10.1016/j.ahj.2007.03.047.

DOI:10.1016/j.ahj.2007.03.047

PMID:17584551

Abstract

BACKGROUND

Outcomes in patients with ST-elevation myocardial infarction (STEMI) differ between those in clinical trials and those in routine practice, as well as across different regions. We hypothesized that adjustment for baseline risk would minimize such variations.

METHODS

The Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction (ExTRACT-TIMI) 25 registry was an observational study of patients with STEMI presenting to hospitals participating in the ExTRACT-TIMI 25 randomized clinical trial. Consecutive patients with STEMI who were not enrolled in the trial were entered into the registry. Demographics, in-hospital therapies, and in-hospital events were collected. Baseline risk was assessed using the TIMI Risk Index for STEMI. To adjust for differences among the countries from which the patients presented, the gross national income per annum per capita (GNI) was used.

RESULTS

A total of 3726 patients were registered from 109 sites in 25 countries. Patients in the registry had a higher baseline risk than those in the trial; they had more extensive prior cardiac histories and more comorbidities. Unadjusted in-hospital mortality was higher in the registry (8.3%) than in the trial (6.6%) (hazard ratio, 1.30; P < .001); however, after adjusting for TIMI Risk Index, mortality was similar (hazard ratio(adj), 1.00; P = .97). The GNI was not significantly predictive of in-hospital mortality in the multivariable model of the registry.

CONCLUSION

Patients in the registry had higher mortality than those in the trial. This difference could be explained by the higher baseline risk of patients in the registry. After adjusting for baseline risk, the GNI of the country in which the patient presented did not contribute to predicting in-hospital mortality.

摘要

背景

ST段抬高型心肌梗死（STEMI）患者的治疗结果在临床试验患者与常规实践患者之间存在差异，并且在不同地区也有所不同。我们假设对基线风险进行调整将使此类差异最小化。

方法

急性心肌梗死治疗中依诺肝素与溶栓再灌注-心肌梗死溶栓（ExTRACT-TIMI）25注册研究是一项对参与ExTRACT-TIMI 25随机临床试验的医院中就诊的STEMI患者进行的观察性研究。未纳入该试验的连续STEMI患者被纳入注册研究。收集人口统计学资料、住院治疗情况和住院期间发生的事件。使用STEMI的TIMI风险指数评估基线风险。为了调整患者来源国家之间的差异，采用人均国民总收入（GNI）。

结果

共从25个国家的109个地点登记了3726例患者。注册研究中的患者基线风险高于试验中的患者；他们有更广泛的既往心脏病史和更多的合并症。注册研究中未调整的住院死亡率（8.3%）高于试验中的死亡率（6.6%）（风险比，1.30；P<.001）；然而，在调整TIMI风险指数后，死亡率相似（调整后风险比，1.00；P = 0.97）。在注册研究的多变量模型中，GNI对住院死亡率没有显著预测作用。