Mild, nondisabling stroke: doubt cast on benefit of alteplase over aspirin

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Takeaway

  • Among patients with nondisabling acute ischemic stroke, alteplase (Activase) was not more efficacious than aspirin.

Why this matters

Key results

  • 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.”

Study design

  • 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.

Limitations

  • Possible variability in deficit extent.
  • Subjective definition of “not clearly disabling.”