MRI-guided alteplase effective for stroke with unknown onset time

  • Thomalla G & al.
  • N Engl J Med
  • 16 May 2018

  • curated by Susan London
  • Clinical Essentials
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Takeaway

  • MRI-guided thrombolysis for ischemic stroke having an unknown time of onset improves neurologic outcome with trade-off of more deaths, intracranial bleeding.

Why this matters

Key results

  • The trial was stopped early as funding ended.
  • Rate of favorable outcome higher with alteplase (Activase) thrombolysis vs placebo (53.3% vs 41.8%; aOR, 1.61; P=.02).
  • Median modified Rankin scale score was better with alteplase (1 vs 2; common aOR, 1.62; P=.003).
  • Trends whereby alteplase group had more deaths (4.1% vs 1.2%; P=.07), symptomatic intracranial hemorrhages (2.0% vs 0.4%; P=.15).
  • Editorialist: “Although the findings of the WAKE-UP trial provide reason for optimism, many questions remain. It is important that clinical equipoise be maintained so that confirmatory trials can be performed.”

Study design

  • Multicenter randomized controlled trial among 503 patients having stroke with an unknown time of onset, but MRI ischemic lesion suggesting onset ~4.5 hours earlier (WAKE-UP trial).
  • Randomization: intravenous alteplase, placebo.
  • Main outcome: 90-day favorable outcome (score of 0 or 1 on modified Rankin scale).
  • Funding: European Union Seventh Framework Program.

Limitations

  • Patients with planned thrombectomy excluded.
  • Limited power.

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