A recent meta-analysis published in Neurology indicates that tenecteplase, a clot-busting drug, may lead to better recovery outcomes in patients with ischemic stroke compared to alteplase, the current FDA-approved standard treatment. The study, which pooled data from 11 randomized controlled trials, suggests a higher likelihood of excellent recovery and reduced disability three months after stroke in patients treated with tenecteplase.
Tenecteplase vs. Alteplase: A Comparative Analysis
The meta-analysis encompassed 3,788 patients who received tenecteplase and 3,757 patients who received alteplase within 4.5 hours of stroke symptom onset. Researchers defined "excellent recovery" as a score of 0 to 1 on the modified Rankin Scale (mRS), indicating no significant disability despite some symptoms. They found that tenecteplase was associated with a 5% higher likelihood of excellent recovery compared to alteplase.
Furthermore, the study revealed that patients treated with tenecteplase had a 10% greater chance of reduced disability, defined as a drop of one point or more on the mRS at three months. However, the likelihood of achieving a "good recovery," defined as an mRS score of 0 to 2 (slight disability), was similar between the two treatment groups.
Clinical Implications and Expert Opinions
"Our meta-analysis shows that while both drugs have similar safety and increase the chances of good recovery after stroke, tenecteplase is superior to alteplase with a greater chance of excellent recovery and reduced disability," said Dr. Georgios Tsivgoulis, chair of neurology with the National and Kapodistrian University of Athens in Greece, and study author. "Our findings support using tenecteplase over alteplase when treating people for ischemic stroke."
Dr. José Morales, a vascular neurologist and neurointerventional surgeon at Providence Saint John’s Health Center, who was not involved in the study, noted the practical advantages of tenecteplase. "The ease of use of TNK continues to be backed by valid clinical data and has implications for systems of care," he stated, highlighting that tenecteplase's single-dose administration simplifies the thrombolysis process and facilitates faster transfers between hospitals.
Dr. Christopher Yi, a vascular surgeon at Memorial Orange Coast Medical Center, also not involved in the study, emphasized the potential for tenecteplase to streamline treatment, reduce treatment times, and improve patient outcomes. He cautioned, however, that regulatory barriers and medicolegal considerations must be addressed for effective implementation.
Considerations and Future Directions
The researchers acknowledged several limitations, including the unpublished status of detailed study results for three of the included trials at the time of the meta-analysis. They also noted that the study-level analysis precluded subgroup analyses and confounding adjustments. Additionally, variations between original and biocopy tenecteplase formulations warrant further investigation.
Despite these limitations, the findings suggest a potential paradigm shift in acute ischemic stroke treatment. While alteplase has been the first-line treatment for decades, tenecteplase offers potential advantages in terms of efficacy and ease of administration. Currently, tenecteplase is approved for treating heart attacks in the U.S. but is used off-label for stroke. Future steps may involve seeking FDA approval for this indication.
