Evaluation of applied cases of thrombolytic therapy against ultra-acute ischemic stroke. Using the Japanese Standard Stroke Registry Database.

BACKGROUND: A retrospective evaluation was made concerning thrombolytic therapy for ultra-acute ischemic stroke patients, using a recombinant tissue plasminogen activator (rt-PA), which is not yet approved as a drug for brain infarction in Japan. The evaluation was implemented using the database of patients that suffered acute strokes as collected by the Japanese Standard Stroke Registry Study (JSSRS).

METHODS: The thrombolytic therapy group, selected from among the registered 6,090 cases of brain infarction patients, was divided into two groups, namely, a group of patients who were admitted in the hospital within 3 hours of the onset (86 cases, average age 69.6) and the other group who were admitted after 3 hours from the onset (28 cases, average age 66.8). Using a Multiple Logistic Regression Analysis adapted for modified Rankin scale (mRS) regarding each group, the clinical effects of thrombolytic therapy for functional outcome and presence or absence of dementia at the time of hospital discharge were examined. Among the 467 cases of patients (average age 74) who were admitted within 3 hours of the onset and for whom the NIH Stroke Scale (NIHSS) was between 6 and 29 at the time of admission, intravenous or intra-arterial thrombolytic therapy was conducted in 88 cases. Then, a case-control study and Multiple Logistic Regression Analysis was implemented for subject groups matched according to the gender, age and severity at the time of admission, and the effects on early-admitted patients were examined. Also, for two rehabilitation patient groups: one whose rehabilitation started within 7 days (216 cases; average age 73) and the other whose rehabilitation started after 7 days (56 cases, average age 76), the effects of early rehabilitation were examined using Multiple Logistic Regression Analysis. Moreover, the effects of thrombolytic therapy on a group of patients who were admitted early and for whom rehabilitation started early (215 cases; average age 73) were examined in the same way.

RESULTS: In the comparison between the thrombolytic therapy groups, the functional outcome of the group of patients admitted within 3 hours of the onset at the time of discharge (mRS 0-1) was significantly better compared with that of the group after 3 hours from the onset (OR 2.79, 95% CI: 1.06-7.32). Regarding the comparison between the early admitted patients, the frequency of poor functional outcomes (mRS 2-6) at the time of discharge was significantly lower in the thrombolytic therapy group (OR 0.55, 95% CI 0.31-0.98), and the frequency of dementia was also significantly lower (OR 0.37, 95% CI 0.17-0.86). In the case control study, a significant difference was noted for the presence of dementia. In the group rehabilitation was started early, the frequency of poor functional outcomes was significantly lower (OR 0.33, 95% CI 0.11-0.98), and the frequency of dementia was also significantly lower (OR 0.41, 95% CI 0.19-0.89). As for the comparison of the groups admitted early and for which rehabilitation started early, the frequency of poor functional outcomes at the time of discharge was significantly lower in the thrombolytic therapy group (OR 0.38, 95% CI 0.16-0.86).

CONCLUSIONS: From the present analysis, in spite of being a retrospective analysis based on comparatively small number of patient cases from the stroke database, it is concluded that the clinical application of thrombolytic therapy for ultra-acute ischemic strokes was effective. Moreover, it was demonstrated that, if it is possible to start rehabilitation early, a dramatic improvement of the effects might be expected.