„Early ischemic signs” haben keine prädiktive Aussage für den Erfolg und die Komplikationsrate der systemischen Thrombolyse

Zusammenfassung

Die in Deutschland weitgehend strikte Beachtung von > 33 % early ischemic signs (EIC) im Territorium der mittleren Hirnarterie im CCT als Ausschlusskriterium für die intravenöse Lysebehandlung des akuten Mediainfarktes beruht im Wesentlichen auf den beiden ECASS-Studien. Beide Studien waren bekanntlich negativ bezüglich des Effektes der Lysebehandlung. Die bisher einzig positive systemische Lysestudie, die NINDS-Studie, benützte das CCT nur zum prospektiven Blutungsausschluss. EIC wurden nicht prospektiv ausgewertet. Eine post-hoc-Analyse der Daten der NINDS-Studie bezüglich der EIC ergab, dass diese keine prädiktive Bedeutung für den Erfolg noch die Komplikationen hatten. Im Gegenteil hatten Patienten mit EIC > 33 % besonders von der Lyse profitiert. In diesem Beitrag werden die Argumente gesammelt, dass auch in Deutschland Patienten innerhalb des 3-h-Zeitfensters nicht von der intravenösen Lyse alleinig aufgrund von CCT-Kriterien ausgeschlossen werden.

Abstract

Early ischemic changes (EIC) on the initial CCT which involve more than 33 % of the territory of the middle cerebral artery (MCA) are currently used in Germany as exclusion criteria for the application of intravenous thrombolysis. These criteria were adopted on the basis of two ECASS studies, both of which were negative as regards any therapeutic effect of intravenous thrombolysis. The only positive thrombolysis study conducted so far, the NINDS- rt-PA trial, used CCT only to prospectively exclude intracerebral hemorrhage; it did not evaluate any EIC. A recent post-hoc analysis of the NINDS-rt-PA trial as regards EIC concluded that these subtle signs had no predictive value as regards success or complications of thrombolysis. However, the study also showed that patients with EIC > 33 % of the MCA territory had benefitted the most from the treatment. This article summarizes the evidence for changing the current treatment rules in Germany so that no acute stroke patient (within 3 hours of symptom begin) is excluded from intravenous thrombolysis on the basis of only CCT criteria.

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