Local mild hypothermia with thrombolysis for acute ischemic stroke within a 6-h window

Objective: To determine the safety and efficacy of combined local mild hypothermia and IV rtPA in treating acute ischemic stroke (AIS) patients with MRI perfusion- and diffusion-weighted imaging (PWI/DWI) mismatch within a 6-h stroke window. Methods: AIS patients within 6 h of a minimum 20% PWI/DWI MRI mismatch were randomly assigned to 3 groups: local mild hypothermia with IV rtPA (Group A); IV rtPA (Group B); or conventional anti-platelet aggregation (Group C). Mortality and National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) score and Barthel Index (BI) were used in evaluation. Results: There were significant differences in NIHSS 24h after treatment among the three groups (P < 0.001). Based on mRS and BI, more patients in Groups A and B showed favorable outcomes than patients in Group C (P = 0.017 and P = 0.009, respectively); however, there were no significant efficacy differences between Groups A and B. The incidence of symptomatic ICH and the mortality rates within 90 days in the 3 groups were similar. In addition, there were no significant differences in NIHSS improvement at 24h and favorable outcomes 90 days after IV rtPA treatment between patients within 3 h and 3-6 h from symptom onset. Conclusions: There was no benefit of combined local hypothermia/IV rtPA treatment compared to IV rtPA alone. PWI/DWI mismatching on MRI can be a selection criteria for IV rtPA treatment within a 6-h window. (C) 2011 Elsevier B.V. All rights reserved.