Effectiveness of t-PA in acute ischemic stroke - Outcome relates to appropriateness

Objective: To examine whether the demonstrated efficacy of tissue-type plas minogen activator (t-PA) for acute ischemic stroke can be effective in a co mmunity setting. Methods: Sixty-eight consecutive patients with acute ische mic stroke treated with IV t-PA within 3 hours of symptom onset by attendin g general neurologists in a busy teaching hospital. Outcome measures at 3 m onths were the National Institute of Health Stroke Scale (NIHSS), functiona l outcome (independence [modified Rankin score 0-2], dependence [modified R ankin score 3-5], and death), and symptomatic hemorrhage. Appropriately hea ted patients were defined by adherence to the National Institute of Neurolo gical Disorders and Stroke (NINDS) guidelines. Effectiveness is expressed a s the absolute risk reduction in which the baseline risk is assumed to be s imilar to that of the NINDS control group. Results: Of 68 consecutively tre ated patients (with a mean baseline NIHSS score of 15 +/- 6), 26 (38%) made a full recovery and 39 (57%) made an independent recovery. The 11 patients who violated protocol had a lower probability of independence (p < 0.02) a nd full neurologic recovery (p < 0.02) and a higher probability of symptoma tic hemorrhage (p < 0.05) and death (p < 0.01) compared with those of 57 pa tients treated according to NINDS guidelines. Conclusions: The use of t-PA for stroke in this community is effective with a number needed to treat of six. The risk of symptomatic hemorrhage is similar to that noted in randomi zed trials. Treating patients who violate protocol results in excess risk w ith no observable benefit.