Alteplase compared to Tenecteplase - AcT

Jul 11, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Canadian Institutes of Health Research; Alberta Strategy for Patient Oriented Research Support Unit.
Date Published:
06/28/2022
Original Posted Date:
07/11/2022
References

Contribution To Literature:

The AcT trial showed that tenecteplase is noninferior to alteplase at preserving neurological function after acute ischemic stroke. 

Description:

The goal of the trial was to evaluate tenecteplase compared with alteplase among patients with acute ischemic stroke.

Study Design

  • Randomization
  • Parallel
  • Open-label

Patients with acute ischemic stroke were randomized to intravenous tenecteplase (0.25 mg/kg to maximum of 25 mg) (n = 816) versus intravenous alteplase (0.09 mg/kg bolus, then 60-minute infusion of the remaining 0.81 mg/kg) (n = 784).

  • Total number of enrollees: 1,600
  • Duration of follow-up: median 97 days
  • Mean patient age: 74 years
  • Percentage female: 48%

Inclusion criteria:

  • 18 years or older with acute ischemic stroke within 4.5 hours of symptom onset and eligible for thrombolysis

Principal Findings:

The primary outcome, modified Rankin Scale score of 0 or 1, occurred in 36.9% of the tenecteplase group compared with 34.8% of the alteplase group. The lower bound 95% confidence interval of the difference in primary outcome rate (–2.6%) was greater than –5% (noninferiority established) (p for superiority = 0.19).

Secondary outcome:

  • Intracerebral hemorrhage: 3.4% in the tenecteplase group vs. 3.2% in the alteplase group

Interpretation:

Among patients with acute ischemic stroke, tenecteplase was noninferior to alteplase at preserving neurological function. Given the ease of administration of tenecteplase, this agent may be preferred for the treatment of patients with acute ischemic stroke.

References:

Menon BK, Buck BH, Singh N, et al., on behalf of the AcT Trial Investigators. Intravenous tenecteplase compared with alteplase for acute ischemic stroke in Canada (AcT): a pragmatic, multicenter, open-label, registry-linked, randomized, controlled, non-inferiority trial. Lancet 2022;Jun 28:[Epub ahead of print].

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

Keywords: Cerebral Hemorrhage, Cognition, Geriatrics, Ischemic Stroke, Neurology, Primary Prevention, Stroke, Tenecteplase, Thrombolytic Therapy, Tissue Plasminogen Activator, Vascular Diseases


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