- good for understanding why the earliest intervention times "should" decrease disability. I think new thrombolytic studies would be best to do on patients treated in 1-2 h, rather than up to 4.5 h of onset.
Unfortunately for patients the lack of evidence supporting the use of tPA for acute stroke is overcome by Hospitals ability to make money, a lot of money, with the Stroke Alert process. Pity the poor ED Physician who steps in front of that train. I have always said that if I ever have a stroke give me tPA. If I can't stand up and walk give it to me again
Why are you ignoring all the RCTs that have shown a benefit to tPA, especially the numerous trials that use imaging to prove there is ischemic penumbra?
Oral nattokinase seems quite safe to consume long-term. Doesn't seem like something to be scared of in an acute setting. I think it is ridiculous it has not been studied for this. It's a reasonable approach that is in between overkill and adminstering nothing. One study reported like 40% reduction in carotid plaque volume for God's sake. The fact that people haven't even heard of this says a great deal about medical bias.
p.s. The conclusion paragraph is refreshingly clear and to the point. God I wish more poeple would write like that.
IV DMSO also seems to be an acceptable intervention in an acute setting, but DMSO is treated like garlic to a vampire by the medical establishment. I take oral nattokinase and DMSO daily, but there is no money to be made with such interventions in a healthcare setting. Alteplase costs over $4000 for a 50 mg vial, so there’s not much chance we’ll ever see RCTs on nattokinase or DMSO.
I’m curious yet again about what these “randomization errors” may have been. Was it an “error” in simply observing that the 2 groups appear to have meaningful differences; or was there an actual mistake or protocol violation in the conduct of the randomization process itself?
It’s also strange that table 1 baseline characteristics is listed with P values. My understanding is that baseline characteristics simply are what they are, and that there is no role for determining “statistical differences” among them.
But I agree, if technically feasible and infarct size and vascular anatomy are in the goldilocks zone, stent retriever seems like the better way to go.
Individualized decision. Thrombectomy if an option. Having seen dramatic improvements in profoundly disabled patients, IF I met the criteria for administration (which should include severity assessment), I’d still opt for treatment. Personal choice though; large, dominant ischemic hemispheric stroke is also catastrophic. TIA’s are not an indication (usually smaller vessels), and LVO (large vessel occlusion) do not typically resolve spontaneously.
"To be honest, having looked at this data, I am not sure what I would want in the setting of a stroke not amenable to mechanical intervention." I truly appreciate this honest reveal as your final conclusion / closing statement. Unfortunately, it leaves those of us who are less informed about managing a stroke in hard place.
At this point if I had a severe stroke I'd opt for mechanical thrombectomy if possible. Secondly, I'd
decline (or ask my POA to decline) TNK as there is no clear benefit and risk of serious harm based on the 1st of all do no harm" dictum.
The real conundrum is that in reality, it sounds like typically is little or no opportunity to discuss treatment options based on the current SOP & perceived short window of time to initiate TNK .
Looks like there's no good evidence that the treatment is beneficial, yet it's been accepted as "standard of care." Will it be included in the 2nd edition of Ending Medical Reversal . . . ?
I remember that IST3 was widely praised for proving IV thrombolysis for Stroke is brain saving , even though a quick glance at the results indicated the opposite. That was gobsmacking.
The NINDS trials were heavily criticised at the time, but the ED “deniers” failed to get their message across. They were largely castigated for that. I remember Jerome Hoffman, ACEP, Buchan, Donnan, Hachinski, Hankey, Joanna Wardlaw...
Thank you for this analysis. Many ED docs recognize that TNK isn’t great, but we have guidelines we have to adhere to… Long ago I told my husband that if I can’t consent for TNK (because my Rankin score is so bad) then I shouldn’t get it. The worse the stroke, it seems, the less likely TNK is to help.
nice short video shows a visual stroke progression that's medically very interesting -
https://www.youtube.com/watch?v=aiXfoVIsjNY
- good for understanding why the earliest intervention times "should" decrease disability. I think new thrombolytic studies would be best to do on patients treated in 1-2 h, rather than up to 4.5 h of onset.
Unfortunately for patients the lack of evidence supporting the use of tPA for acute stroke is overcome by Hospitals ability to make money, a lot of money, with the Stroke Alert process. Pity the poor ED Physician who steps in front of that train. I have always said that if I ever have a stroke give me tPA. If I can't stand up and walk give it to me again
Why are you ignoring all the RCTs that have shown a benefit to tPA, especially the numerous trials that use imaging to prove there is ischemic penumbra?
Please provide references
Oral nattokinase seems quite safe to consume long-term. Doesn't seem like something to be scared of in an acute setting. I think it is ridiculous it has not been studied for this. It's a reasonable approach that is in between overkill and adminstering nothing. One study reported like 40% reduction in carotid plaque volume for God's sake. The fact that people haven't even heard of this says a great deal about medical bias.
p.s. The conclusion paragraph is refreshingly clear and to the point. God I wish more poeple would write like that.
IV DMSO also seems to be an acceptable intervention in an acute setting, but DMSO is treated like garlic to a vampire by the medical establishment. I take oral nattokinase and DMSO daily, but there is no money to be made with such interventions in a healthcare setting. Alteplase costs over $4000 for a 50 mg vial, so there’s not much chance we’ll ever see RCTs on nattokinase or DMSO.
I’m curious yet again about what these “randomization errors” may have been. Was it an “error” in simply observing that the 2 groups appear to have meaningful differences; or was there an actual mistake or protocol violation in the conduct of the randomization process itself?
It’s also strange that table 1 baseline characteristics is listed with P values. My understanding is that baseline characteristics simply are what they are, and that there is no role for determining “statistical differences” among them.
But I agree, if technically feasible and infarct size and vascular anatomy are in the goldilocks zone, stent retriever seems like the better way to go.
Thanks for covering this JMM! Nice to have a respected cardiologist/methodologist weigh in. Do u think another RCT justified?
Would love to hear u and Adam talk about this on next fortnight.
Is VP coming back?
We need another volume of ending medical reversal!
Would also love to hear stroke doctors weight in.
Individualized decision. Thrombectomy if an option. Having seen dramatic improvements in profoundly disabled patients, IF I met the criteria for administration (which should include severity assessment), I’d still opt for treatment. Personal choice though; large, dominant ischemic hemispheric stroke is also catastrophic. TIA’s are not an indication (usually smaller vessels), and LVO (large vessel occlusion) do not typically resolve spontaneously.
"To be honest, having looked at this data, I am not sure what I would want in the setting of a stroke not amenable to mechanical intervention." I truly appreciate this honest reveal as your final conclusion / closing statement. Unfortunately, it leaves those of us who are less informed about managing a stroke in hard place.
At this point if I had a severe stroke I'd opt for mechanical thrombectomy if possible. Secondly, I'd
decline (or ask my POA to decline) TNK as there is no clear benefit and risk of serious harm based on the 1st of all do no harm" dictum.
The real conundrum is that in reality, it sounds like typically is little or no opportunity to discuss treatment options based on the current SOP & perceived short window of time to initiate TNK .
Looks like there's no good evidence that the treatment is beneficial, yet it's been accepted as "standard of care." Will it be included in the 2nd edition of Ending Medical Reversal . . . ?
I remember that IST3 was widely praised for proving IV thrombolysis for Stroke is brain saving , even though a quick glance at the results indicated the opposite. That was gobsmacking.
The NINDS trials were heavily criticised at the time, but the ED “deniers” failed to get their message across. They were largely castigated for that. I remember Jerome Hoffman, ACEP, Buchan, Donnan, Hachinski, Hankey, Joanna Wardlaw...
Also :
Ryan Radecki (look up his blog https://www.emlitofnote.com/?s=thrombolysis )
And a recent (2020) blog note by Salim Rezaie that recaps there are zero positive trials for thrombolysis in acute ischemic stroke:
https://rebelem.com/thrombolysis-in-acute-ischemic-stroke-now-we-have-no-positive-rcts/
Thank you for this analysis. Many ED docs recognize that TNK isn’t great, but we have guidelines we have to adhere to… Long ago I told my husband that if I can’t consent for TNK (because my Rankin score is so bad) then I shouldn’t get it. The worse the stroke, it seems, the less likely TNK is to help.
Well said - I hope you don’t cop a backlash for giving an assessment on less than robust data.