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Prognostische Bedeutung der ST-Strecken-Veränderung beim akuten Myokardinfarkt

Impact of prediction of outcome by early ST segment changes in acute myocardial infarction

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Zusammenfassung

Das Ausmaß der Rückbildung der ST-Strecken-Hebung (STR) 180 Minuten nach Beginn einer Streptokinasebehandlung bei akutem Myokardinfarkt bis sechs Stunden nach Symptombeginn ist ein exzellenter prognostischer Frühindikator. In einer Metaanalyse von 3 912 Infarktpatienten wiesen etwa 50% eine komplette STR (STR≥70%) auf. Diese Patienten entwickeln kleine Infarkte und haben eine sehr hohe Überlebenswahrscheinlichkeit. Etwa 20% weisen keine STR (STR<30%) auf. Sie entwickeln große Infarkte und haben ein hohes Sterberisiko. Patienten mit partieller STR haben zwar größere Infarkte, aber die Überlebenschancen sind noch relativ gut.

Mit Hilfe der STR ließ sich unter Berücksichtigung des Alters und der Anzahl weiterer bekannter Risikofaktoren aus Anamnese und Akutphase ein Niedrigrisikokollektiv mit einer so geringen Akut- und Ein-Jahres-Sterblichkeit ermitteln, daß zumindest für dieses Subkollektiv eine routinemäßige Koronarographie in der frühen Postinfarktphase nicht gerechtfertigt ist. Darüber hinaus ist STR geeignet, auch in Hochrisikokollektiven zwischen relativ stärker und weniger stark gefährdeten Patienten zu unterscheiden.

In der Thrombolyseforschung ist STR hervorragend als Surrogatparameter einzusetzen. Insbesondere trifft das für Dosisfindungsstudien, als primärer Endpunkt in Phase-III-Studien und für Interimsanalysen, Subgruppenanalysen, Substudien und Sicherheitsanalysen in großen Mortalitäts-studien zu. STR kann erheblich zur Reduktion der erforderlichen Stichprobenumfänge in klinischen Studien beitragen. Allerdings ist zumindest eine große Mortalitätsstudie unerläßlich, um das Risiko von Hirnblutungen und anderen Blutungskomplikationen zu erfassen.

Abstract

The extent of ST segment elevation resolution (STR) 180 minutes after initiation of streptokinase treatment for acute myocardial infarction within 6 hours after onset of symptoms is an excellent early prognostic indicator that can be easily determined in all patients. This presentation is based on a meta-analysis from 3 thrombolysis studies including 3 912 patients. About 50% of patients had complete STR (≥70%). They had small enzymatic infarct sizes and well preserved left ventricular function associated with an excellent chance of survival. Patients with partial STR (<70 to 30%) developed larger infarcts, but had still a relatively low mortality. To assess the optimal cut-off point that best predicts an increased mortality risk, the squared standardized log odds ratio statistics as a function of the hypothetical cut-off points in STR was used. A cut-off point around 30% STR was associated with an extraordinarily strong predictive power. The 35-day cardiac mortality with STR <30% was 12.7% as compared to 2.1% for patients who had complete STR and 4.2% for those who had partial STR.

Based on STR, age, medical history, and simple parameters at admission, a low risk population can be defined that includes about 50% of all patients aged≤70 years, and 20% of older patients. The 35-day and 1-year mortality rates for the group of younger patients was 1.4% and 2.7%, respectively, and for the older age group 5.0% and 7.9%. It appears highly unlikely that aggressive testing and interventions would have any measurable beneficial effect on such a good outcome.

In thrombolytic therapy comparative trials STR may perform well as a surrogate endpoint, since it is more powerful than 90 minutes post-thrombolytic patency rates and early mortality, in a statistical sense. This is especially true for Phase-II dosefinding studies and the use as a surrogate or even primary endpoint in phase-III trials. In addition, STR may be very helpful for safety monitoring, interim analyses, and subgroup analyses in megatrials with the endpoint mortality. Use of STR can result in a substantial reduction in the required sample size. However, at least 1 pivotal mortality trial cannot be replaced by STR trials, since STR does not reflect the risk of intracranial hemorrhages and other bleeding complications.

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Correspondence to Rolf Schröder.

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Wescheider, K., Neuhaus, K.L., Dissmann, R. et al. Prognostische Bedeutung der ST-Strecken-Veränderung beim akuten Myokardinfarkt. Herz 24, 378–388 (1999). https://doi.org/10.1007/BF03043929

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