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I take issue with the assertions that "adults with ischaemic stroke NEED thrombolysis within 4.5 hours" and "policy makers need to push for ever faster treatment times".
Registry data is interesting and certainly useful for hypothesis generation, however it is difficult to reconcile the above statements (delivered as fait accompli facts) with the results of all RCTs conducted to date examining the use of tPA for acute ischaemic stroke.
There are 2 positive trials; NINDS and ECASS-III. Both have significant methodologic flaws or biases which detract significantly from the reliability, or clinical applicability, of their conclusions. The more recently published IST-3, despite its authors' creative conclusions, was a negative trial, despite the presence of significant potential biases in favour of finding a treatment effect.
It is likely that thrombolysis does benefit a subset of patients who present to hospital with acute ischaemic stroke. Unfortunately, at this time we lack the evidence to accurately identify who they are, and in the meantime we do significant harm to patients by lysing all-comers on the basis of insufficient and unconvincing evidence.
Given the existing evidence, I think a more cautious approach is warranted. Thrombolysis of acute stroke patients should only occur in the context of a trial, and we certainly should not be encouraging policy makers, the public and/or emergency physicians to facilitate greater uptake and faster door-to-treatment times for a demonstrably harmful intervention that remains without proven benefit.
Competing interests:
No competing interests
25 June 2013
Christopher Cole
Emergency Medicine Registrar
ACT Health
The Canberra Hospital, Yamba Dr, Garran ACT 2605 Australia
Re: Lives lost with every 15 minute delay in thrombolysis after acute stroke
I take issue with the assertions that "adults with ischaemic stroke NEED thrombolysis within 4.5 hours" and "policy makers need to push for ever faster treatment times".
Registry data is interesting and certainly useful for hypothesis generation, however it is difficult to reconcile the above statements (delivered as fait accompli facts) with the results of all RCTs conducted to date examining the use of tPA for acute ischaemic stroke.
There are 2 positive trials; NINDS and ECASS-III. Both have significant methodologic flaws or biases which detract significantly from the reliability, or clinical applicability, of their conclusions. The more recently published IST-3, despite its authors' creative conclusions, was a negative trial, despite the presence of significant potential biases in favour of finding a treatment effect.
It is likely that thrombolysis does benefit a subset of patients who present to hospital with acute ischaemic stroke. Unfortunately, at this time we lack the evidence to accurately identify who they are, and in the meantime we do significant harm to patients by lysing all-comers on the basis of insufficient and unconvincing evidence.
Given the existing evidence, I think a more cautious approach is warranted. Thrombolysis of acute stroke patients should only occur in the context of a trial, and we certainly should not be encouraging policy makers, the public and/or emergency physicians to facilitate greater uptake and faster door-to-treatment times for a demonstrably harmful intervention that remains without proven benefit.
Competing interests: No competing interests