Prethrombectomy intravenous tenecteplase is noninferior to intravenous alteplase to improve reperfusion and functional outcome in patients with ischemic stroke who are treated within a 4.5-hour period following the onset of symptoms, according to a randomized study published in the New England Journal of Medicine.
Patients with ischemic stroke with large-vessel occlusion of the internal carotid, middle cerebral, or basilar artery who were eligible to receive intravenous thrombolysis and endovascular thrombectomy were included in this analysis (N=202). Investigators randomly assigned patients to receive either 0.25 mg/kg tenecteplase (n=101) or 0.9 mg/kg alteplase (n=101) within 4.5 hours after the onset of stroke symptoms. Substantial reperfusion, defined as >50% of blood flow to the involved ischemic territory or the absence of retrievable thrombus at the initial angiographic evaluation, comprised the primary outcome.
A significantly greater proportion of patients treated with tenecteplase achieved substantial reperfusion compared with those treated with alteplase (22% vs 10%, respectively; incidence difference, 12 percentage points; 95% CI, 2-21; incidence ratio, 2.2; 95% CI, 1.1-4.4; P =.002 for noninferiority; P =.03 for superiority). Additionally, prethrombectomy tenecteplase was associated with significantly better functional outcome at 90 days compared with alteplase (median modified Rankin scale score, 2 vs 3; common odds ratio 1.7; 95% CI, 1.0-2.8; P =.04). Symptomatic intracerebral hemorrhage developed in only 1 patient from each group. There were 10 deaths in the tenecteplase group and 18 deaths in the alteplase group.
The findings from this trial are limited only to those with ischemic stroke with large-vessel occlusion who are deemed appropriate for thrombolysis.
A benefit of tenecteplase is that it can be administered in a single bolus vs the 1-hour infusion administration of alteplase, which “may be of practical benefit in patients with stroke with large-vessel occlusion who are transported between, as well as within, hospitals to access endovascular thrombectomy.”
Campbell BCV, Mitchell PJ, Churilov L, et al; for the EXTEND-IA TNK Investigators. Tenecteplase versus alteplase before thrombectomy for ischemic stroke. N Engl J Med. 2018;378(17):1573-1582.