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Vergleich der superselektiven intraarteriellen Fibrinolyse mit konservativer Therapie

Einsatz bei Patienten mit akutem nichtarteriitischem Zentralarterienverschluss

Comparison of superselective intraarterial fibrinolysis with conservative therapy

Use in patients with acute non-arteritic central retinal artery occlusion

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Zusammenfassung

Der nichtarteriitische Zentralarterienverschluss (ZAV) ist noch immer eine Erkrankung mit schlechter Visusprognose. Als Hoffnungsträger bei der Behandlung galt die superselektive Lysetherapie, bei der ein Fibrinolytikum über einen Katheter in der A. ophthalmica injiziert wird. Die „European Study Group for lysis in the Eye“ (EAGLE) hatte sich zum Ziel gesetzt, die Wirksamkeit dieser Lysetherapie in einer prospektiven und randomisierten Studie zu untersuchen. Dabei wurden die Ergebisse eines konservativen Therapieschemas (KoTh) mit denen der intraarteriellen superselektiven Lysetherapie (LyTh) verglichen. Eingeschlossen wurden Patienten (Alter: 18–75 Jahre) mit einem nichtarteriitischen ZAV mit einer Dauer von maximal 20 h und einer bestkorrigierten Sehschärfe (BCVA) von mehr als 0,5 logMAR („logarithm of the minimum angle of resolution“; entspricht <0,32 dezimal). Die Patienten wurden in eine der beiden Gruppen (KoTh oder LyTh) randomisiert. Hauptzielkriterium war die bestkorrigierte Sehschärfe 1 Monat nach Behandlung, Nebenzielkriterium war die Sicherheit der Therapie. Die durchschnittliche BCVA stieg in beiden Gruppen signifikant an, es zeigte sich kein Gruppenunterschied. In der Lysegruppe gab es eine höhere Rate an unerwünschten Ereignissen. Die EAGLE-Studie wurde nach der ersten Interimsanalyse vorzeitig beendet. Zusammenfassend ist die intraarterielle Fibrinolyse bei nahezu identischer funktioneller Verbesserung in beiden Gruppen und einer höheren Komplikationenrate nicht mehr für die Therapie von Patienten mit akutem nichtarteriitischem ZAV zu empfehlen.

Abstract

The results of conservative treatment for central retinal artery occlusion (CRAO) vary considerably and although local intraarterial fibrinolysis (LIF) is a promising treatment, outcomes have not been compared in randomized trials. The prospective randomized multicenter study by the European Assessment Group for Lysis in the Eye (EAGLE) is the first clinical trial to compare treatment outcomes of conservative standard treatment (CST) and LIF for acute non-arteritic CRAO. Patients (age 18–75 years) with CRAO present for less than 20 h and best-corrected visual acuity (BCVA) <0.5 logMAR were randomized to either CST or LIF group. Primary endpoint was BCVA after 1 month and secondary endpoint was safety. Mean BCVA (logMAR) improved significantly in both groups and did not differ between the groups. Because of similar efficacy and the higher rate of adverse events in the LIF group the study was halted after the first interim analysis. Due to the similar outcomes of the two therapies and the higher rate of adverse reactions associated with LIF superselective lysis cannot be recommended for the management of acute CRAO.

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Interessenkonflikt

Die EAGLE-Studie, an der die Autoren beteiligt waren, wurde unterstützt von der Deutschen Forschungsgemeinschaft (DFG) Bonn (SCHU1454/1–3) und von Boehringer Ingelheim Pharma KG.

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Authors and Affiliations

  1. Augenklinik der Ludwig-Maximilians-Universität, Mathildenstraße 8, 80336, München, Deutschland

    A. Wolf & A.S. Neubauer

  2. Klinik für Neuroradiologie, Neurozentrum, Universitätsklinikum Freiburg, Freiburg, Deutschland

    M. Schumacher

  3. Zentrum für klinische Studien, Universitätsklinikum Freiburg, Freiburg, Deutschland

    C. Schmoor & C. Gall

  4. Augenklinik, Universitätsklinikum Essen, Essen, Deutschland

    B. Jurklies

  5. Klinik für Neuroradiologie, Universitätsklinikum Essen, Essen, Deutschland

    I. Wanke

  6. Klinik für Neuroradiologie, Universitätsklinikum Würzburg, Würzburg, Deutschland

    L. Solymosi

  7. Klinik für Neuroradiologie, Universitätsklinikum München, München, Deutschland

    H. Brückmann

  8. Augenklinik, Universitätsklinikum Freiburg, Freiburg, Deutschland

    D. Schmidt

  9. Augenklinik, Universitätsklinikum Göttingen, Göttingen, Deutschland

    N. Feltgen

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  1. A. Wolf
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  2. M. Schumacher
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  3. A.S. Neubauer
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  10. D. Schmidt
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für die European Assessment Group for Lysis in the Eye Studien Gruppe

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Correspondence to A. Wolf.

Additional information

Dr. Wolf und Prof. Schumacher haben zu gleichen Teilen zu der Arbeit beigetragen.

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Wolf, A., Schumacher, M., Neubauer, A. et al. Vergleich der superselektiven intraarteriellen Fibrinolyse mit konservativer Therapie. Ophthalmologe 107, 799–805 (2010). https://doi.org/10.1007/s00347-010-2247-z

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