- Among patients with nondisabling acute ischemic stroke, alteplase (Activase) was not more efficacious than aspirin.
Why this matters
- Clinical guidelines note alteplase use in this population is gray area.
- Trial stopped early because of slow recruitment (313 of 948 planned patients).
- 90-day favorable functional outcome was not different between alteplase and placebo (78.2% vs 81.5%; adjusted risk difference, −1.1%; 95% CI, −9.4% to 7.3%).
- Symptomatic intracranial hemorrhage was more common with alteplase (3.2% vs 0%; risk difference, 3.3%; 95% CI, 0.8%-7.4%).
- Editorialist: “Even with early study termination and resultant wide 95% confidence intervals, the excellent outcome in the aspirin group and the numerically similar outcomes between the 2 groups render it unlikely that intravenous alteplase treatment meaningfully improves functional outcome in patients with initial NIHSS scores of 5 or lower with nondisabling deficits.”
- PRISMS randomized clinical trial of acute ischemic stroke patients; deficits 0-5 on National Institutes of Health Stroke Scale, not clearly disabling, study treatment initiated ≤3 hours.
- Study arms: intravenous alteplase (0.9 mg/kg) plus oral placebo vs oral aspirin (325 mg) plus intravenous placebo.
- Main outcome: favorable functional outcome (modified Rankin Scale score 0/1).
- Funding: Genentech.
- Possible variability in deficit extent.
- Subjective definition of “not clearly disabling.”