EXTEND-IA TNK
Trial question
What is the role of tenecteplase among patients with ischemic stroke who are eligible to undergo thrombectomy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 202
202 patients (92 female, 110 male).
Inclusion criteria: patients within 4.5 hours after onset of ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy.
Key exclusion criteria: severe preexisting disability with mRS score > 3, pregnancy, ICH, rapidly improving symptoms at the discretion of the investigator.
Interventions
N=101 tenecteplase (at a dose of 0.25 mg/kg of body weight with a maximum dose of 25 mg).
N=101 alteplase (at a dose of 0.9 mg/kg with a maximum dose of 90 mg).
Primary outcome
Reperfusion of > 50% of involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment
22%
10%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Tenecteplase
Alteplase
Significant
increase ▲
NNH = 8
Significant increase in reperfusion of > 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment (22% vs. 10%; IR 2.2, 95% CI 1.1 to 4.4).
Secondary outcomes
Significant increase in median mRS score at 90 days (2 points vs. 3 points; OR 1.7, 95% CI 1 to 2.8).
Borderline significant increase in incidence of recovery to independent function; mRS score of 0-2 at 90 days (64% vs. 51%; IR 1.2, 95% CI 1 to 1.5).
No significant difference in early neurologic improvement at 72 hours (71% vs. 68%; IR 1, 95% CI 0.9 to 1.2).
Safety outcomes
No significant differences in symptomatic intracerebral hemorrhage, parenchymal hematoma.
Significant difference in death (10% vs. 18%).
Conclusion
In patients within 4.5 hours after onset of ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy, tenecteplase was superior to alteplase with respect to reperfusion of > 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment.
Reference
Bruce C V Campbell, Peter J Mitchell, Leonid Churilov et al. Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke. N Engl J Med. 2018 Apr 26;378(17):1573-1582.
Open reference URL