Objective: To examine whether the demonstrated efficacy of tissue-type plasminogen activator (t-PA) for acute ischemic stroke can be effective in a community setting.
Methods: Sixty-eight consecutive patients with acute ischemic stroke treated with IV t-PA within 3 hours of symptom onset by attending general neurologists in a busy teaching hospital. Outcome measures at 3 months were the National Institute of Health Stroke Scale (NIHSS), functional outcome (independence [modified Rankin score 0-2], dependence [modified Rankin score 3-5], and death), and symptomatic hemorrhage. Appropriately treated patients were defined by adherence to the National Institute of Neurological Disorders and Stroke (NINDS) guidelines. Effectiveness is expressed as the absolute risk reduction in which the baseline risk is assumed to be similar to that of the NINDS control group.
Results: Of 68 consecutively treated 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) and full neurologic recovery (p < 0.02) and a higher probability of symptomatic hemorrhage (p < 0.05) and death (p < 0.01) compared with those of 57 patients 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 randomized trials. Treating patients who violate protocol results in excess risk with no observable benefit.