Abstract WP121: Can The Extended Glasgow Outcome Scale (e-gos) Augment The Interpretation Of Results From Clinical Trials Of Minimally Invasive Surgery Of Spontaneous Intracerebral Hemorrhage Using The Modified Rankin Scale (mrs): A Secondary Analysis Of The Clear-iii And Mistie-iii Trials

Abstract

Introduction: Currently, the modified Rankin scale (mRS) is most commonly used to assess functional outcome in clinical trials of interventions for spontaneous intracerebral hemorrhage (ICH). Extended Glasgow Outcome Score (eGOS) is often used to assess global disability/recovery after traumatic brain injury and provides additional discrimination of vegetative state (VS) from lower severe disability (LSD). We compared primary outcomes from 2 clinical trials of minimally invasive surgery for intracerebral and intraventricular hemorrhage (ICH/IVH) at different thresholds of eGOS. Methods: Post-hoc analysis of primary outcomes (PO) from the CLEAR-III trial (intraventricular alteplase [IVtPA] vs. saline for obstructive IVH; N=500; PO: mRS 0-3 at day 180), and MISTIE-III trial (stereotactic thrombolysis [MIS+tPA] vs. conservative management; N=499; PO: mRS 0-3 at day 365). eGOS was derived from functional outcome scales obtained during the trials. Outcomes on eGOS were categorized into 5 subgroups: good outcomes: 7-8 (A), 5-6 (B), 4 (C), and poor outcomes: 3 (D), and 1-2 (E). Generalized, ordered logistic regression analysis was performed, adjusting for age, ICH location, stability ICH and IVH volumes, and randomization GCS. Results: eGOS scales were available in 481 (96%) patients at day 180 in CLEAR-III and 478 (96%) patients at day 365 in MISTIE-III. In CLEAR-III, odds of being in eGOS category D (LSD) or E (death or VS) vs. the others, were approximately 40% lower for IVtPA group compared to saline group (aOR = 0.59; 95% CI, 0.38-0.90; p=0.016), and odds of being in category E (vs. the others) were almost 50% lower (aOR = 0.51; 95% CI, 0.33-0.80; p=0.004). VS occurred in 2.49% of IVtPA and 2.07% of saline group patients. In MISTIE-III, odds of being in eGOS category D or E (vs. the others) were not significantly different for MIS+tPA vs. conservative treatment: aOR = 0.84; 95% CI, 0.55-1.28; p=0.41), as were odds for being in eGOS category E (vs. the others), aOR = 0.77; 95% CI, 0.48-1.24; p=0.29). Conclusions: The 5-category dichotomized eGOS (4-8 vs. 1-3) defines a functional outcome improvement in CLEAR-III at day 180, which was not observed using the PO with mRS. Use of eGOS did not result in a different interpretation of the MISTIE-III trial.