Why Is the Extended Window Controversial and What Happened With the FDA?

September 7, 2021

Ever wonder why the FDA didn't approve the extended time window for tPA after ECASS3? Listen here to understand the discussion.

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The Good, the Bad and the Ugly of the NIHSS: Time for a Change?

August 31, 2021
The NIHSS remains the fundamental assessment of stroke severity. However, some have called for modifying the NIHSS to better capture disability. Is it time to change the NIHSS?
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What Else Beyond the NIHSS Should We Be Doing Clinically?

August 24, 2021
The NIHSS was a research tool meant to limit variability and provide uniform quantifiable assessments  of stroke severity.  As the de facto standard for stroke exams and scores, it has withstood the test of time.  However, there is more to the assessment of acute stroke severity and this podcast takes a deep dive into what else we need to be doing besides the NIHSS.
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The Clock Is Dead - The Reign of Tissue Imaging

August 17, 2021
Mismatch is your friend if you want to treat acute stroke patients beyond 3 hrs. While the clock was once the king, tissue imaging may now define what brain is salvageable and what has been lost. Listen here and see if you agree that the clock is dead in stroke.
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Defining the SOC - Is 4.5 Hrs the Real Answer?

August 10, 2021
The standard of care can feel elusive. Listen here as Dr. Knight shares his expertise regarding the definition of the SOC in extended window therapy for tPA. It's not a simple question and Dr. Knight is the one to answer it.
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Sep 7

Why Is the Extended Window Controversial and What Happened With the FDA?

Haemin posted on 9/7/2021

Moderator: William A. Knight IV, MD, FACEP, FNCS
Other Participants: Stacie L. Demel, DO, PhD

The ECASS 3 trial was an RCT of IV-rtPA in the window of 3-4.5 hrs after onset of stroke symptoms. It was conducted in Europe. The European regulatory bodies have endorsed tPA for that window, but the FDA has not. Listen to two national experts in stroke discuss the trial and the meaning of the endorsement or lack thereof. This podcast is a must for acute stroke practitioners!

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2 comments on article "Why Is the Extended Window Controversial and What Happened With the FDA?"

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Ken Milne

I watched the video on ECASS-III and you mentioned the controversy in this time window. However, there was no mention of Alper et al reanalysis in the BMJ_EBM that questioned the results? Can you comment? https://ebm.bmj.com/content/25/5/168


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Ken Milne

Here was some of our feedback on Alper et al https://ebm.bmj.com/content/early/2020/08/10/bmjebm-2020-111517

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