Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion - TEMPO-2

May 28, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research, and British Heart Foundation
Date Published:
05/17/2024
Date Updated:
05/28/2024
Original Posted Date:
05/29/2024
References

Contribution To Literature:

The TEMPO-2 trial failed to show that intravenous tenecteplase improves outcomes and may result in harm during minor acute ischemic stroke.

Description:

The goal of the trial was to evaluate intravenous thrombolytic therapy (tenecteplase) compared with standard therapy among patients with minor acute ischemic stroke.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with minor acute ischemic stroke were randomized to intravenous tenecteplase 0.25 mg/kg (n = 432) vs. standard therapy (n = 454).

  • Total number of enrollees: 886
  • Duration of follow-up: median 92 days
  • Mean patient age: 72 years
  • Percentage female: 42%
  • Percentage with diabetes: 19%

Inclusion criteria:

  • Minor acute ischemic stroke defined as National Institutes of Health Stroke Scale score 0-5
  • Intracranial occlusion or focal perfusion abnormality

Exclusion criteria:

  • >12 hours from symptom onset

Principal Findings:

The primary outcome, return to baseline functioning on premorbid modified Rankin Scale score, was 72% in the tenecteplase group vs. 75% in the standard therapy group (p = 0.29).

Secondary outcomes:

  • Mortality at 90 days: 5% in the tenecteplase group vs. 1% in the standard therapy group (p = 0.0085)
  • Symptomatic intracranial hemorrhage: 2% in the tenecteplase group vs. <1% in the standard therapy group (p = 0.059)

Interpretation:

Among patients with minor acute ischemic stroke, intravenous tenecteplase failed to improve return to baseline functioning on premorbid modified Rankin Scale score. Tenecteplase was also associated with a numerical increase in symptomatic intracranial hemorrhage and a significant increase in mortality at 90 days compared with standard therapy.

References:

Coutts SB, Ankolekar S, Appireddy R, et al., on behalf of the TEMPO-2 Investigators. Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion (TEMPO-2): A Randomized, Open Label, Phase 3 Superiority Trial. Lancet 2024;May 17:[Epub ahead of print].

Clinical Topics: Cardiovascular Care Team, Dyslipidemia, Vascular Medicine, Lipid Metabolism, Novel Agents, Prevention

Keywords: Ischemic Stroke, Tenecteplase


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