Stroke neurologists spent the first decade of the tPA era explaining away negative studies and excluding patients from meta-analyses secondary to “protocol violations”, emphasizing that strict adherence to NINDS criteria supports clear benefit to tPA. As we’ve seen, however, the new push is rather to take back the night, expanding the treatment window out to 4.5 hours, 6 hours, the extreme elderly, and all sorts of previously excluded patients.
But we don’t need evidence to do that – we just need Genentech to fly a select group of experts out to a meeting so they can issue a report in support of throwing out the previous exclusion criteria: The Re-examining Acute Eligibility for Thrombolysis (TREAT) Task Force. The astute reader might already recognize the prevailing bias just from the acronym for their group.
This is the first report, specifically addressing “rapidly improving stroke symptoms”. I agree with the general concept – if a severely disabled patient has shown some improvement, but are still profoundly limited – it is reasonable to consider them a candidate for treatment. The original NINDS group was interested primarily in excluding TIAs – folks they thought would go on to have zero residual disability. However, these authors are already over the cliff on treating nearly every improving and mild stroke symptom. In true flabbergasting lunacy, a majority of surveyed participants wouldn’t even randomize patients who rapidly improved to an NIHSS of 0 into a clinical trial comparing outcomes with tPA vs. placebo – unless the patient had zero disability, they would simply treat.
I’m no longer surprised by such extreme viewpoints. After all, here are the authors’ significant COIs:
Broderick: Genentech, Novo Nordisk, Schering Plow, PhotoThera
Grotta: none
Kasner: Genentech
Khatri: Genentech (for a study called “Potential for rtPA to Improve Strokes with Mild Symptoms”!), Penumbra, Jannsen, Lake Biosciences, Medical Dialogues
Levine: Genentech
Meyer: Genentech, The Medicines Company
Panagos: Genetench
Romano: Genentech
Scott: none
Kim: none
“Logistical support for the in-person meeting was provided by Infusion, An InforMed Group Company, who was funded by Genentech, Inc. Travel funds (lodging, airfare, and food) to this meeting were also provided to some participants by Genentech, Inc.”
I cannot fathom why stroke neurologists are still befuddled by continued skepticism towards their tPA recommendations when they persist in pumping out recommendations saturated by bias.
“Review, Historical Context, and Clarifications of the NINDS rt-PA Stroke Trials Exclusion Criteria : Part 1: Rapidly Improving Stroke Symptoms”
www.ncbi.nlm.nih.gov/pubmed/23847249