Development of intracranial hemorrhage (ICH) negatively impacts functional outcomes in ischemic stroke. This impact may be more significant in minor ischemic stroke given the relatively minor presenting symptoms. The goal of this secondary analysis was to assess the effect of ICH on functional outcomes in patients with minor ischemic stroke. This is a secondary analysis of the TEMPO-2 randomized controlled trial evaluating Tenecteplase (0.25mg/kg) versus standard care in patients with minor stroke (NIHSS 0-5) with visible occlusion and/or perfusion mismatch presenting within 12 hours of onset. Hemorrhage grade was assessed using the Heidelberg bleeding classification at 24-hour follow up imaging. Symptomatic ICH (SICH) was defined as any hemorrhage temporally related to neurological worsening. Patients with any ICH on follow-up imaging were compared to those without any ICH. Primary outcome was return to baseline neurological functioning using 90-d modified Rankin scale (mRS). Mixed-effects regression analysis was conducted adjusting for age, sex, baseline stroke severity, and onset to randomization time as fixed effects and region as random effects variable. Of 884 enrolled participants, 865 with complete imaging and follow up data were included, of which 102(11.8%) had ICH. Baseline characteristics comparing patients with any ICH vs no ICH were similar, except higher rates of hypertension 73 (71.6%) vs 440 (57.7%) and atrial fibrillation 29(28.4%) vs 138(18.1%) in the ICH group. There was no difference in primary outcome between the groups adjOR 0.94(95% CI 0.88-1.00). Mortality was significantly higher in ICH vs no ICH adjHR 3.85(95% CI 1.60-9.26). All other secondary outcomes were similar between groups(Table 1). Within the ICH group, rates of any ICH were significantly higher in tenecteplase vs control 62(14.4%) vs 40(9.2%), p=0.02. Although SICH rates were numerically higher, these were not statistically significant in tenecteplase vs control 2 (0.5%) vs 8 (1.9%), p=0.06. Among patients with any hemorrhages, over half were HI-1 and HI-2 (Table 2, Fig. 1). While functional outcomes were similar, patients with any ICH had higher mortality. Any hemorrhage was more frequent with tenecteplase compared to control arm, although majority were petechial hemorrhages. These findings underscore the importance of further studies to clarify the impact of hemorrhage in minor stroke and to optimize thrombolysis strategies in this population.
Massicotte et al. (Thu,) studied this question.