Rather than restrict TPA for acute ischemic stroke to the small cohort of patients identified by strict exclusion criteria in the few completed randomized trials, the current crusade is to continue to try and give it to more patients on the fringes of eligibility.
This article promotes giving TPA to patients with “minor or rapidly improving” strokes, because the lead author (sponsored by Genentech) sees this classification of patients is responsible for 50% of the documented reasons why patients were excluded from receiving TPA. In fact, if patients with mild and improving strokes received TPA, it would immediately double the rate of TPA use – and provide potentially excellent outcomes at 90 days for the manufacturers.
They base their assertions on a retrospective, uncontrolled evaluation of the discharge disposition of patients in this “minor or rapidly improving” cohort – and observe that only 72% of patients in this group were discharged home. In their mind, patients could do much better (as measured by disposition location) if they had received TPA – and their final conclusion is that this exclusion criteria should be further studied so that it may be revoked.
But, their conclusions are a preposterous farce conjured out of fictionalization of the data. Considering the median age of their cohort was 72, 30% of whom had prior stroke/TIAs, 26% were diabetic, 76% were hypertensive, etc. – the sheer fact that only 28% went to rehab/SNF/died is probably rather good performance. The authors also admit they had no information regarding the initial residence of this mostly elderly cohort and have no idea if the patients discharged to nursing facilities originally resided there. Finally, the article additionally states “outcomes for patients with mild/rapidly improving stroke were better than for rtPA-treated patients with mild stroke (NIHSS score of 0 to 5) but worse for patients with a final diagnosis of TIA.”
Yes, they compared this mild stroke cohort data to the mild stroke cohort data that received TPA, and all outcomes – adjusted and unadjusted for NIHSS – significantly favored the non-TPA cohort.
….so the obvious conclusion is to find a way to give more of them TPA.
Lunacy. Another example of bad literature undermining trust in a probably efficacious treatment.
“Outcomes in Mild or Rapidly Improving Stroke Not Treated With Intravenous Recombinant Tissue-Type Plasminogen Activator”
www.ncbi.nlm.nih.gov/pubmed/21903949
Quick, treat em before they get better!
I see a lot of this on the prehospital side of things, but never with a drug as dangerous as tPA. Thanks for sharing.