Baseline Leukoaraiosis Does Not Modify Clinical Outcomes in Patients With Spontaneous Intracerebral Hemorrhage.

Background: Prior studies have suggested that baseline leukoaraiosis before ICH may be associated with high mortality, initial large hematoma volume, and may be an independent risk factor for worse outcomes after ICH, yet leukoaraiosis is not included in prognostic criteria for ICH. We hypothesized that increased leukoaraiosis burden at baseline would be associated with worse outcomes in patients enrolled in the Safety of Pioglitazone for Hematoma Resolution in ICH (SHRINC) trial. Methods: Patients enrolled in SHRINC had a baseline brain MRI per protocol. We performed a retrospective analysis of leukoaraiosis measured on baseline MRI. Baseline leukoaraiosis scoring was measured using the Fazekas score (FS). Patients were stratified into two groups based on FS, none-mild (FS 0-1) and moderate-severe (FS 2-3). FS was evaluated as a treatment modifier for mRS, NIHSS and Barthel Index. Comparisons were performed by Chi-square, Fisher’s Exact or Wilcoxon rank sum, linear or logistic regression models were developed to test FS as a treatment effect modifier on outcomes. Results: A total of 78 subjects had baseline MRIs (37 PIO, 41 Placebo) suitable to determine FS. There was no difference in important prognostic variables between the two groups (Table). There was no significant interaction between FS and treatment group at 90 or 180 days regarding good outcome, NIHSS, Barthel index (p= 0.18, 0.31, 0.40, respectively). Conclusions: Our analysis revealed that the presence of baseline moderate to severe leukoaraiosis was not associated with baseline presentation nor treatment effect on outcomes. Our findings raise the question whether our traditional outcome measures are able to detect deficit due to leukoaraisosis and future studies should consider outcomes measures which can better quantify deficits attributable to leukoaraiosis.