ESOC Conference Insights: New Data on Thrombolysis With Tenecteplase

Breaking news from the European Stroke Organisation Conference (ESOC) in Lyon, France. Neurology Learning Network Section Editor, Armou Sarraj, MD, gives a synopsis of 3 recent randomized clinical trials that were presented today at ESOC. Dr Sarraj will be providing key insights and coverage of ESOC as the conference continues.

Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke (AcT trial) 

This is a phase 3, open-label, randomized clinical trial assessing intravenous (IV) tenecteplase (tNK) vs IV alteplase (tPA) in patients with acute ischemic stroke analyzed in 22 centers across Canada. 

From the 22 centers, 1600 patients were randomized to the following groups: the intervention group, receiving IV tNK 0.25 mg/kg body weight; and the control group, receiving tPA 0.9 mg/kg body weight. The intention-to-treat population included 771 patients treated with tPA compared with 806 treated with tNK.

Clinicians found that the primary outcome (mRS 0-1) demonstrated noninferiority of tNK (tNK 36.9% vs tPA 34.8%), and rates of symptomatic intracerebral hemorrhage (tNK 3.4% vs tPA: 3.1%) did not differ between the 2 arms.

The trial concluded that tNK is a “reasonable alternative to tPA in patients with acute ischemic stroke.”

The Norwegian Tenecteplase Stroke Trial 2 (NOR-TEST2) 

This is a phase 3 randomized clinical trial evaluating the efficacy and safety of intravenous (IV) tenecteplase (tNK) vs IV alteplase (tPA) in patients with moderate to severe ischemic stroke (National Institutes of Health Stroke Scale > 6) across 11 centers across Norway. 

In this trial, 216 patients were randomized to either the tNK 0.4 mg/kg (single bolus) or the tPA 0.9 mg/kg (10% bolus + 90% infusion/60 min) groups. Of participants, 204 were included in the primary intention-to-treat analysis (100 tNK vs 104 tPA).

Researchers found tNK was associated with lower rates of excellent outcomes as follows: mRS 0-1 (tNK 32% vs tPA 51%), increased mortality (tNK 16% vs tPA 5%), and hemorrhages (tNK 21% vs tPA 7%).

The trial was stopped for futility and safety concerns.

Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (TASTE-A)

This is a phase 2, randomized, open-label clinical trial assessing intravenous (IV) tenecteplase (tNK) vs IV alteplase (tPA) for the treatment of ischemic stroke at the Melbourne Mobile Stroke Unit (MSU) and 5 tertiary hospitals in Melbourne, Victoria, Australia.

This trial was conducted in an MSU setting in which 104 patients were randomized to the following groups: IV tNK 0.25 mg/kg administered as a bolus over approximately 10 seconds; or IV tPA 0.9 mg/kg administered at 10% bolus and the remainder over 1 hour. 

Researchers noted, tNK was associated with a smaller perfusion lesion (DT3) volume (tNK 12 [3-28] mL vs tPA 35 [18-76] mL, P = .003) on arrival at the stroke center. Secondary outcomes including profound disability or death (mRS 5-6: tNK 15% vs tPA 20%) or mortality (tNK 9% vs tPA 10%) did not differ significantly between the 2 arms.

The trial concluded that treatment with tNK on the MSU in Melbourne resulted in a superior rate of early reperfusion compared with aTP, and no safety concerns were noted.

The trial provides evidence to support the use of tNK and MSUs in an optimal model of stroke care.

References

Menon B, Swartz R. Alteplase compared to tenecteplase (ACT) randomized controlled trial. Presented at: European Stroke Organisation Conference; May 4, 2022; Lyon, France.

Fromm A. Tenecteplase versus alteplase for management of acute ischemic stroke (NOR-TEST 2 Part A): a phase 3, randomised, open-label, blinded endpoint trial. Presented at: European Stroke Organisation Conference; May 4, 2022; Lyon, France.

Bivard A. The Melbourne mobile stroke unit tenecteplase versus alteplase for stroke thrombolysis evaluation trial in the ambulance (TASTE-A). Presented at: European Stroke Organisation Conference; May 4, 2022; Lyon, France.