Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events-2 - TRACE-2

Feb 21, 2023
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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:
National Science and Technology Major Project, Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, National Natural Science Foundation of China, and China Shijiazhuang Pharmaceutical Company.
Date Published:
02/09/2023
Original Posted Date:
02/21/2023
References

Contribution To Literature:

The TRACE-2 trial showed that tenecteplase was noninferior to alteplase among patients with acute ischemic stroke.

Description:

The goal of the trial was to evaluate tenecteplase compared with alteplase among patients with acute ischemic stroke. Tenecteplase is easier to administer than alteplase.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with acute ischemic stroke who were eligible for thrombolytic therapy but ineligible for endovascular thrombectomy were randomized to tenecteplase (n = 716) vs. alteplase (n = 714) within 4.5 hours of symptom onset. Tenecteplase was given as a single intravenous bolus at a dose of 0.25 mg/kg, maximum dose of 25 mg. Alteplase was given at a dose of 0.9 mg/kg, maximum dose of 90 mg. Ten percent of the dose was given as a bolus and the remainder given over 1 hour.

  • Total number of enrollees: 1,430
  • Duration of follow-up: 90 days
  • Mean patient age: 67 years
  • Percentage female: 31%
  • Percentage with diabetes: 24%

Inclusion criteria:

  • Acute ischemic stroke
  • At least 18 years of age
  • Modified Rankin Scale (mRS) score 0-1
  • National Institutes of Health Stroke Scale score 5-25

Exclusion criteria:

  • Received or intended to proceed to endovascular thrombectomy

Principal Findings:

The primary efficacy outcome, mRS score of 0-1 at 90 days, occurred in 62% of the tenecteplase group vs. 58% of the alteplase group (p = not significant).

The primary safety outcome, symptomatic intracranial hemorrhage at 36 hours, occurred in 2% of the tenecteplase group vs. 2% of the alteplase group (p = 0.72).

Secondary outcomes:

  • Mortality at 90 days: 7% of the tenecteplase group vs. 5% of the alteplase group (p = 0.22)

Interpretation:

Among patients with acute ischemic stroke, tenecteplase was noninferior to alteplase. Tenecteplase was associated with a similar frequency of mRS score of 0-1 at 90 days. Intracranial hemorrhage and mortality were similar between the two treatment groups. Given the ease of administering tenecteplase, this agent may be preferred over alteplase among patients with acute ischemic stroke ineligible for endovascular thrombectomy.

References:

Wang Y, Li S, Pan Y, et al. Tenecteplase versus alteplase in acute ischemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomized controlled, non-inferiority trial. Lancet 2023; Feb 9:[Epub ahead of print].

Editorial Comment: Menon BK, Singh N, Sylaja PN. Tenecteplase use in patients with acute ischemic stroke. Lancet 2023; Feb 9:[Epub ahead of print].

Clinical Topics: Cardiac Surgery, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Cardiac Surgery and Arrhythmias, Lipid Metabolism, Novel Agents, Interventions and Vascular Medicine

Keywords: Cerebrovascular Disorders, Critical Care, Hemorrhage, Intracranial Hemorrhage, Traumatic, Ischemic Stroke, Secondary Prevention, Stroke, Tenecteplase, Thrombectomy, Tissue Plasminogen Activator, Vascular Diseases


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