Schröder R, Wegscheider K, Schröder K, Dissmann R, Meyer-Sabellek W
Universitätsklinikum Benjamin Franklin, Berlin, Germany.
J Am Coll Cardiol. 1995 Dec;26(7):1657-64. doi: 10.1016/0735-1097(95)00372-x.
This study was undertaken to assess prospectively the prognostic power of early ST segment elevation resolution in a large cohort of patients with myocardial infarction and to test the value of differences in ST segment resolution as a surrogate end point.
Previous studies revealed that the use of two cutoff points for three groups of ST segment resolution within 3 h after the start of thrombolysis is most effective in predicting outcome.
The International Joint Efficacy Comparison of Thrombolytics (INJECT) trial compared mortality in 6,010 patients randomized to receive either reteplase or streptokinase. The 1,909 German patients form the basis of this substudy. The three groups of ST segment resolution were defined as complete (> or = 70%), partial (70% to 30%) and no resolution (< 30% to > or = 0%).
In 1,398 patients presenting < or = 6 h from onset of acute myocardial infarction, the 35-day mortality rate for complete, partial and no ST segment resolution was 2.5%, 4.3% and 17.5%, respectively (p < 0.0001). Peak creatine kinase levels (fraction of normal) were 9.8, 13.4 and 14.0, respectively (p < 0.0001). When baseline characteristics were included, ST segment resolution was the most powerful independent predictor of 35-day mortality. The proportion of patients with complete ST segment resolution was larger, and that with no ST segment resolution smaller, with reteplase than with streptokinase (p = 0.006).
No ST segment resolution, indicating failed thrombolysis, predicts very high early mortality, whereas complete resolution is associated with a small infarct area and low mortality. Partial ST segment resolution also predicts larger infarct areas, but early mortality is relatively low. Different extents of ST segment resolution may serve as a sensitive surrogate end point in clinical trials.
本研究旨在前瞻性评估早期ST段抬高恢复情况对一大群心肌梗死患者的预后预测能力,并检验ST段恢复差异作为替代终点的价值。
先前的研究表明,在溶栓开始后3小时内,对三组ST段恢复情况采用两个截断点最能有效预测预后。
溶栓药物国际联合疗效比较(INJECT)试验比较了6010例随机接受瑞替普酶或链激酶治疗患者的死亡率。1909例德国患者构成了本亚组研究的基础。三组ST段恢复情况定义为完全恢复(≥70%)、部分恢复(70%至30%)和未恢复(<30%至≥0%)。
在1398例急性心肌梗死发病≤6小时就诊的患者中,完全、部分和未ST段恢复的35天死亡率分别为2.5%、4.3%和17.5%(p<0.0001)。肌酸激酶峰值水平(正常比例)分别为9.8、13.4和14.0(p<0.0001)。纳入基线特征后,ST段恢复情况是35天死亡率最有力的独立预测因素。与链激酶相比,接受瑞替普酶治疗的患者中完全ST段恢复的比例更大,未ST段恢复的比例更小(p = 0.006)。
ST段未恢复表明溶栓失败,预示早期死亡率极高,而完全恢复与梗死面积小和死亡率低相关。部分ST段恢复也预示梗死面积较大,但早期死亡率相对较低。不同程度的ST段恢复情况可作为临床试验中一个敏感的替代终点。