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Thrombektomie im späten Zeitfenster. eine retrospektive Analyse der DAWN- und DEFUSE 3-Kriterien im klinischen Alltag innerhalb der multizentrischen German Stroke Registry (GSR)
Thrombektomie im späten Zeitfenster. eine retrospektive Analyse der DAWN- und DEFUSE 3-Kriterien im klinischen Alltag innerhalb der multizentrischen German Stroke Registry (GSR)
Background. In recent years a variety of studies highlighted the importance of the endovascular thrombectomy (EVT) for patients with an ischemic stroke due to an acute occlusion of a vessel in the anterior circulation (aLVO). There may be uncertainty as to how the appropriate EVT- patient should be determined. According to the DAWN and DEFUSE 3-Trials EVT is effective in selected patients with aLVO of up to 24 hours after last seen well (LSW). The main criterium for selecting patients was an adequate result in perfusion imaging. The eligibility is complex and needs validation in a real-life setting. Methods. Data of 1917 patients was provided by the multicenter German Stroke Registry and was analysed retrospectively. A general cohort of 208 participants was formed (11%). These pa- tients presented an aLVO-Stroke within 6 – 24 h and had acceptable baseline-characteristics. 52 patients fitted within the strict DAWN/DEFUSE 3-qualification-criteria (Group 1; DD-like; ~ 2.7%). Results were compared with a group of 27 ineligible patients (Group 2; DD-unlike; 1.4%) and a third group that consisted of 129 participants who mostly disqualified because of the non- existence of perfusion imaging (Group 3; NDND; ~ 6.7%). Primary endpoint was declared as the examination performance on the 90. day after thrombectomy. According to the DAWN / DEFUSE 3 studies, this was described on the modified Rankin Scale (mRS). A good result was defined as a functional independence (mRS-90d: 0-2). Results. Neither the DD-like nor the DD-unlike group could compete with the good results of the clinical comparative studies (mRS-90d 0-2; DD-like: 20% vs. DD-unlike: 27%; p=.343). Nev- ertheless DD-like patients had a significantly lower risk of a bad outcome (mRS-90d 5-6; OR: 0.37 [0.14 – 0.97]; p= .04). DD-unlike patients had significantly more intracerebral hemorrhages (ICH) than other groups (33% vs. 12%) and a higher risk of a bad outcome (OR: 2.73 [1.03-7.20], p= .04). The suspected predictors for a good outcome could not be reproduced (DAWN-eligibil- ity: p= .957; DEFUSE 3-eligibilty: p= .252). Conclusion. The high rate of positive clinical results after 90 days described by DAWN/DEFUSE 3 could not be seen within the dataset on hand. The DAWN- or DEFUSE-3- eligibility could not be reproduced as a predictor for a good outcome but was positively correlated with lower rates of bad clinical outcomes. Patients triaged with neuroimaging other than perfusion showed a trend for shorter reperfusion times and higher rates of physical independence after 90 days., Hintergrund. In den letzten Jahren hat sich die endovaskuläre mechanische Thrombektmie (EVT) zu einer etablierten Therapieoption bei Patient:innen mit einem ischämischen Schlaganfall aufgrund eines akuten Verschlusses eines großen Gefäßes der vorderen Zirkulation (engl. acute Large Vessel Occlusion = aLVO) entwickelt. Ein positiver Effekt auf das klinische Ergeb- nis konnte in randomisierten Studien auch bei Therapien im fortgeschrittenen Zeitfenster von bis zu 24 Stunden nach Einsetzen der klinischen Symptome belegt werden (DAWN- und DEFUSE 3 trial). Der Ansatz, den die Autor:innen der Studien verfolgten, geht von einem positiven Effekt der mechanischen Thrombektomie bei Patient:innen mit einem günstigen radiologisch-klini- schen Mismatch unter Berücksichtigung des Alters aus. Die vorliegende Arbeit versucht diese Ansätze mit Daten aus dem klinischen Alltag zu reproduzieren. Ein weiteres Augenmerk richtet sich auf die Ausarbeitung von möglichen prädiktiven Faktoren für ein gutes klinisches Ergebnis.
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Scherling, Hanns Jörg Korbinian
2023
German
Universitätsbibliothek der Ludwig-Maximilians-Universität München
Scherling, Hanns Jörg Korbinian (2023): Thrombektomie im späten Zeitfenster: eine retrospektive Analyse der DAWN- und DEFUSE 3-Kriterien im klinischen Alltag innerhalb der multizentrischen German Stroke Registry (GSR). Dissertation, LMU München: Faculty of Medicine
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Abstract

Background. In recent years a variety of studies highlighted the importance of the endovascular thrombectomy (EVT) for patients with an ischemic stroke due to an acute occlusion of a vessel in the anterior circulation (aLVO). There may be uncertainty as to how the appropriate EVT- patient should be determined. According to the DAWN and DEFUSE 3-Trials EVT is effective in selected patients with aLVO of up to 24 hours after last seen well (LSW). The main criterium for selecting patients was an adequate result in perfusion imaging. The eligibility is complex and needs validation in a real-life setting. Methods. Data of 1917 patients was provided by the multicenter German Stroke Registry and was analysed retrospectively. A general cohort of 208 participants was formed (11%). These pa- tients presented an aLVO-Stroke within 6 – 24 h and had acceptable baseline-characteristics. 52 patients fitted within the strict DAWN/DEFUSE 3-qualification-criteria (Group 1; DD-like; ~ 2.7%). Results were compared with a group of 27 ineligible patients (Group 2; DD-unlike; 1.4%) and a third group that consisted of 129 participants who mostly disqualified because of the non- existence of perfusion imaging (Group 3; NDND; ~ 6.7%). Primary endpoint was declared as the examination performance on the 90. day after thrombectomy. According to the DAWN / DEFUSE 3 studies, this was described on the modified Rankin Scale (mRS). A good result was defined as a functional independence (mRS-90d: 0-2). Results. Neither the DD-like nor the DD-unlike group could compete with the good results of the clinical comparative studies (mRS-90d 0-2; DD-like: 20% vs. DD-unlike: 27%; p=.343). Nev- ertheless DD-like patients had a significantly lower risk of a bad outcome (mRS-90d 5-6; OR: 0.37 [0.14 – 0.97]; p= .04). DD-unlike patients had significantly more intracerebral hemorrhages (ICH) than other groups (33% vs. 12%) and a higher risk of a bad outcome (OR: 2.73 [1.03-7.20], p= .04). The suspected predictors for a good outcome could not be reproduced (DAWN-eligibil- ity: p= .957; DEFUSE 3-eligibilty: p= .252). Conclusion. The high rate of positive clinical results after 90 days described by DAWN/DEFUSE 3 could not be seen within the dataset on hand. The DAWN- or DEFUSE-3- eligibility could not be reproduced as a predictor for a good outcome but was positively correlated with lower rates of bad clinical outcomes. Patients triaged with neuroimaging other than perfusion showed a trend for shorter reperfusion times and higher rates of physical independence after 90 days.

Abstract

Hintergrund. In den letzten Jahren hat sich die endovaskuläre mechanische Thrombektmie (EVT) zu einer etablierten Therapieoption bei Patient:innen mit einem ischämischen Schlaganfall aufgrund eines akuten Verschlusses eines großen Gefäßes der vorderen Zirkulation (engl. acute Large Vessel Occlusion = aLVO) entwickelt. Ein positiver Effekt auf das klinische Ergeb- nis konnte in randomisierten Studien auch bei Therapien im fortgeschrittenen Zeitfenster von bis zu 24 Stunden nach Einsetzen der klinischen Symptome belegt werden (DAWN- und DEFUSE 3 trial). Der Ansatz, den die Autor:innen der Studien verfolgten, geht von einem positiven Effekt der mechanischen Thrombektomie bei Patient:innen mit einem günstigen radiologisch-klini- schen Mismatch unter Berücksichtigung des Alters aus. Die vorliegende Arbeit versucht diese Ansätze mit Daten aus dem klinischen Alltag zu reproduzieren. Ein weiteres Augenmerk richtet sich auf die Ausarbeitung von möglichen prädiktiven Faktoren für ein gutes klinisches Ergebnis.