Authors: Amelie Pielen Stefanie Pantenburg Claudia Schmoor Martin Schumacher Nicolas Feltgen Bernd Junker Josep Callizo for the EAGLE Study Group
Publish Date: 2015/09/08
Volume: 57, Issue: 10, Pages: 1055-1062
Abstract
The study analyses patients’ risk factors to determine prognostic and predictive factors in patients with acute central retinal artery occlusion CRAO treated in the randomized European Assessment Group for Lysis in the Eye EAGLE Study with local intraarterial fibrinolysis LIF or conservative standard treatment CST These data could improve patient selection for either methodPost hoc statistical analysis of effects of risk factors on overall best corrected visual acuity BCVA logarithm of the minimum angle of resolution logMAR at baseline and month 1 prognostic effect and on the difference between outcome of CST and LIF predictive effect was conductedSeventy two of 84 EAGLE datasets were included Prognostic effect Patients with coronary heart disease CHD presented worse BCVA at baseline 039 logMAR p = 00097 Patients with time from occlusion to treatment 12 h showed a trend to better vision gain at month 1 −023 logMAR p = 0086 similarly smoking −024 logMAR p = 0077 Predictive effect Age 60 years favours LIF −054 logMAR 70 years favours CST 028 logMAR interaction p = 0070 and CHD favours CST 044 logMAR interaction p = 0073 might be predictors of therapeutic outcome There were no strong effects in multivariate analysisCHD time from occlusion to treatment and smoking influence BCVA at baseline and at month 1 prognostic effect Patients treated within 12 h are more likely to profit from treatment In multivariate analysis there is no clear trend to benefit from LIF even in patients with young age no CHD and early treatment Based on this preliminary report on a rather small sample size we do not recommend LIF in CRAO patientsThe EAGLE Study received funding from The German Research Foundation of Health DFG Bonn Germany SCHU1454/13 and from Boehringer Ingelheim Pharma KG The Clinical Trials Center University Hospital Freiburg received funding from the Federal Ministry of Education and Research BMBF AP received support as awardee of the EllenSchmidtProgram of Hannover Medical SchoolWe declare that all human and animal studies have been approved by the appropriate Ethics Committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments We declare that all patients gave informed consent prior to inclusion in this study Clinical Trial RegistrationURL http//wwwclinicaltrialsgov Unique identifier NCT00637468
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