Stroke survivors often face a difficult road to recovery, with many left with lasting disabilities. This research offers new hope for patients with acute ischemic stroke caused by a large blockage in a major blood vessel. The study focuses on those who received a mechanical procedure called thrombectomy within 24 hours of symptom onset. These patients also had a specific score indicating a higher risk of poor outcomes if not treated aggressively. The goal was to see if adding a drug called alteplase directly into the artery could improve results without causing dangerous side effects.
Researchers conducted a randomized trial at 14 stroke centers in Spain. They compared two groups of patients. One group received thrombectomy alone. The other group received thrombectomy plus intra-arterial alteplase. The drug was given at a dose of 0.225 mg per kilogram, up to a maximum of 20 mg, infused over 15 minutes. The teams did not know which treatment each patient received when assessing the main results, though the doctors knew the treatment given. This design helps ensure the findings are reliable.
The main result measured excellent functional outcome at 90 days. This means the patient could perform daily tasks independently. In the group receiving the drug plus the procedure, 57.5 percent achieved this excellent outcome. In the group receiving the procedure alone, 42.5 percent achieved it. This represents a 15 percent increase in the chance of a great recovery. The difference was statistically significant, with a p-value of 0.002. The confidence interval ranged from 5.7 percent to 24.3 percent.
Safety was a major concern. The researchers looked for residual hypoperfusion, which means poor blood flow remaining in the brain. This was much less common in the group receiving the drug. They also checked for symptomatic intracranial hemorrhage, or bleeding inside the skull that causes symptoms. The rate was 1.4 percent in the drug group and 0.5 percent in the procedure-only group. This difference was not statistically significant, meaning the data does not prove the drug caused more bleeding. However, the study did find higher mortality in the drug group. Twelve point one percent died in the drug group versus 6.4 percent in the other group. This difference was statistically significant.
The study has important limitations that patients must understand. The higher death rate in the group receiving the drug warrants further study. Because of this, the evidence is not yet complete. The trial was small, with only 440 patients total. It was also open-label, meaning the treating doctors knew which treatment was given, which can influence care. The funding source was not reported. These factors mean the results should not be viewed as definitive proof that this approach is better for everyone.
For patients right now, this study suggests that adding intra-arterial alteplase might increase the chance of excellent recovery. It did not significantly increase the risk of bleeding in this specific group. However, the increased mortality rate is a serious concern that needs more investigation. Patients should discuss these trade-offs with their doctors. This single trial does not change standard practice immediately. More research is needed to confirm if the benefits outweigh the risks of higher death rates. Patients should not start or stop any medication based on this report alone.