Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours | NEJM

Summary

A phase 3 trial in China evaluated tenecteplase as a thrombolytic agent for ischemic stroke patients without access to thrombectomy. Administered 4.5 to 24 hours post-stroke, it showed a higher rate of patients with no disability at 90 days (33.0% vs. 24.2% with standard care). However, it also increased the risk of symptomatic intracranial hemorrhage (3.0% vs. 0.8%). The study suggests tenecteplase may offer benefits beyond the 4.5-hour window for eligible patients.

Takeaways

• 🏥 Large-vessel ischemic stroke patients without access to endovascular thrombectomy can benefit from tenecteplase administered within 4.5 hours.
• 🕒 Over two-thirds of ischemic stroke patients present beyond the 4.5-hour window or have an unknown onset time, limiting their treatment options.
• 🧪 A new trial explores the efficacy of tenecteplase administered 4.5 to 24 hours after stroke onset in eligible patients.
• 🏥 This phase 3 trial included 516 Chinese adults with ischemic stroke due to anterior-circulation large-vessel occlusion.
• 💉 Participants were randomized to receive intravenous tenecteplase at a dose of 0.25 mg per kg of body weight or standard medical treatment.
• 📊 The primary outcome measured was a modified Rankin scale score of 0 or 1 at day 90, indicating less disability.
• 🌟 Tenecteplase treatment showed a higher percentage of patients with a modified Rankin Scale score of 0 or 1 at 90 days (33.0%) compared to standard medical treatment (24.2%).
• ⚠️ A key safety concern was the incidence of symptomatic intracranial hemorrhage within 36 hours after treatment, which was higher in the tenecteplase group (3.0%) than in the standard treatment group (0.8%).
• 👨‍⚕️ The authors conclude that tenecteplase administered 4.5 to 24 hours after stroke onset is more effective in reducing disability at 90 days in Chinese patients without thrombectomy access.
• 🔍 Full trial results can be found at NEJM.org for further detailed analysis and information.

Q & A

What is the significance of the treatment discussed in the script for patients with large-vessel ischemic stroke?

The treatment discussed in the script is significant because it offers an effective thrombolytic agent, tenecteplase, for patients who do not have access to endovascular thrombectomy and present beyond the typical 4.5-hour window post-stroke onset.

What is the time frame for administering tenecteplase according to the new trial mentioned in the script?

The new trial evaluated the efficacy and safety of tenecteplase when administered between 4.5 to 24 hours after stroke onset.

Which group of patients was included in the phase 3 trial?

The phase 3 trial included 516 Chinese adults with ischemic stroke due to anterior-circulation large-vessel occlusion who had salvageable tissue 4.5 to 24 hours after stroke onset and did not have access to thrombectomy.

What was the dosage of tenecteplase administered in the trial?

Patients were assigned to receive intravenous tenecteplase at a dose of 0.25 mg per kg of body weight, up to a maximum of 25 mg.

What was the primary outcome measure used in the trial?

The primary outcome was a modified Rankin scale score at day 90, with higher scores indicating greater disability, and the goal was to achieve a score of 0 or 1.

What was the percentage of patients with a modified Rankin Scale score of 0 or 1 at 90 days in the tenecteplase group?

In the tenecteplase group, 33.0% of patients had a modified Rankin Scale score of 0 or 1 at 90 days.

How did the tenecteplase treatment compare to standard medical treatment in terms of the primary outcome?

The results favored tenecteplase treatment, which had a higher percentage of patients with no or minimal disability at 90 days compared to standard medical treatment.

What was the incidence of symptomatic intracranial hemorrhage within 36 hours after treatment in the tenecteplase group?

The incidence of symptomatic intracranial hemorrhage within 36 hours after treatment was higher in the tenecteplase group, at 3.0%, compared to 0.8% in the standard medical treatment group.

What conclusion did the authors draw from the trial results?

The authors concluded that in Chinese patients with ischemic stroke who did not have access to thrombectomy, tenecteplase administered 4.5 to 24 hours after stroke onset resulted in a higher percentage of patients with no disability at 90 days than standard medical treatment.

Where can the full trial results be found?

The full trial results are available at NEJM.org.