R.E.B.E.L.EM - July 27, 2020 - By Salim Rezaie
"Clinical Question: Does removing confounders and effect modifiers in patients from the original NINDS trials change the outcomes of alteplase given within 3 hours of symptom onset for acute ischemic stroke?
Author Conclusion: “Reanalysis of the ECASS III trial data with multiple approaches adjusting for baseline imbalances does not support any significant benefits and continues to support harms for the use of alteplase 3—4.5 hours after stroke onset. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stoke that were based on ECASS III results.”
Clinical Take Home Point: The re-analysis of ECASS III raises concerns that baseline imbalances create bias and affect the conclusions of efficacy of alteplase given within 3 to 4.5 hours after stroke onset in acute ischemic stroke compared to placebo.
Clinical Bottom Line: There have been only two randomized clinical trials to show benefit of systemic alteplase vs placebo in acute ischemic stroke. After balancing for baseline differences in patients between the two groups, re-analysis of these two trial questions the validity and robustness of alteplase. This means there are now ZERO RCTs supporting the practice of thrombolysis in acute ischemic stroke."