NASHVILLE — Tenecteplase tissue plasminogen activator (TNK-tPA) is a safe and effective thrombolytic agent for patients suffering from minor stroke with intracranial occlusion, according to a study presented at the American Stroke Association’s International Stroke Conference 2015.
Patients who suffer a minor stroke or transient ischemic attack with intracranial occlusion have a 20% to 30% risk of neurological deterioration and resulting disability. Currently, these patients are treated with alteplase. The researchers in this study wanted to see if TNK-tPA could potentially be a better treatment, since TNK-tPA is easier to administer, has a longer half-life, has higher fibrin specificity, and possibly has a lower rate of intracranial hemorrhage compared with alteplase.
The study was part of TEMPO-1, a multi-center TNK-tPA dose-escalation, safety, and feasibility trial. It included 50 patients with a National Institute of Health Stroke Scale/Score (NIHSS) <6, intracranial arterial occlusion, and no sign of well-evolved infarction who were treated within 12 hours of their stroke. Half of the patients received doses of 0.1 mg/kg of TNK-tPA, and the other half received doses of 0.25 mg/kg.
The study’s primary outcome was the rate of symptomatic intracranial and extracranial hemorrhage, with secondary outcomes of complete neurological and functional recovery at 90 days, recanalization after four to eight hours, and minor bleeding.
The results showed that one symptomatic intracranial hemorrhage occurred in the 0.1 mg/kg group, and none occurred in the 0.25 mg/kg group.
In the 0.1 mg/kg group, 21.7% of patients had full recanalization after 4-8 hours, with 26.1% having partial, and 52.2% with none. In the 0.25 mg/kg group, 56.6% of patients had full recanalization after 4-8 hours, with 13% having partial, and 30.4% with none.
The results of this study indicate that TNK-tPA is both a safe and effective thrombolytic agent in minor stroke with intracranial occlusion. The researchers will proceed to use the 0.25 mg/kg dosing in a randomized, controlled trial.
For more coverage of the International Stroke Conference 2015, go here.
- Coutts, SB et al. Abstract 160. International Stroke Conference. Feb. 12 2015. Nashville, Tennessee.