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 24 h 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 24 h 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.