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CONTROVERSY over the role of thrombolysis in acute stroke is likely to be reignited after a call to roll it out more widely was rejected by some emergency physicians.
An editorial in this week’s MJA says it is time for Australia to move beyond discussing the efficacy and feasibility of implementing the therapy and work towards a more coordinated system of applying the evidence.(1)
“A coordinated system of care for stroke and transient ischaemic attack in Australia has been stalled by the lack of a concerted effort to adopt thrombolysis,” the editorial said.
A study in the same issue showed clinical outcomes in Australia for stroke after treatment with recombinant tissue plasminogen activator (rt-PA) were similar to those worldwide.(2)
But Professor Daniel Fatovich, Professor of Emergency Medicine at the University of Western Australia, said many emergency physicians still considered thrombolysis highly controversial.
“There are a lot of emergency physicians around the world who still don’t accept it as a proven treatment and consider it as something that has been adopted without sufficient evidence,” Professor Fatovich said.
“Even the Cochrane review last year says the data is unstable.”(3)
The observational study in the MJA reported for the first time the Australian results of rt-PA treatment for stroke from 2002‒2008.
The results were recorded in the Safe Implementation of Thrombolysis in Stroke International Stroke Thrombolysis Register (SITS-ISTR) and compared with data collected from 32 other countries.
After adjusting for clinical and demographic characteristics, there were no statistically significant differences in any primary outcomes between the Australian cohort of 581 patients and 20 953 patients in the rest of the world. The 3-month intracerebral haemorrhage mortality rate was 2.2%.
Study coauthor Dr Christopher Levi, director of acute stroke services at John Hunter Hospital in NSW, said it was urgent to roll out rt-PA more widely because it was a powerful and effective treatment that could lead to a complete cure in some patients.
But there had been many barriers, including lack of patient and ambulance officer awareness and refusal in the past by the Australasian College for Emergency Medicine (ACEM) to endorse rt-PA guidelines, he said.
ACEM’s scientific committee chairman Dr Anthony Cross said the study results indirectly supported the view of many emergency physicians that complex, time-critical therapies should be carefully implemented in integrated stroke services.
“[It] provides no reason for those who still have reasonable and legitimate concerns relating to the underlying scientific justification of this therapy to change their views,” Dr Cross said.
“Bluntly speaking, this paper shows that we can give thrombolysis as well as anyone in the world but does not seek to answer if, when or to whom we should give thrombolysis.”
ACEM recently endorsed the National Stroke Foundation Clinical Guidelines for Stroke Management, which covered the use of thrombolysis in appropriately selected patients in centres equipped to deliver the therapy safely.
MJA editorial coauthor Professor Richard Gerraty, Victorian chairman of the Australasian Stroke Unit Network, said the first step was for hospitals to acknowledge that rt-PA worked and then organise uptake of the treatment.
“If you pick the patient [and] stick to the protocol, you will benefit some patients, there will be some you don’t benefit and in a very small number you may cause harm and cause a haemorrhage. That is the same for all treatments,” Professor Gerraty said.
1. MJA 2010; 193: 436-437.
2. MJA 2010; 193: 439-443.
3. Cochrane Database Syst Rev 2009; (4): CD000213. doi: 10.1002/14651858. CD000213.pub2.
Posted 18 October 2010
While a quick scan of the headline would suggest that Emergency Physicians are “just being difficult” (again), the article sets out many of the reasons why it is logical to be wary of the claims being made for thrombolysis in stroke. How many of us actually understand the data well?
This is not like thrombolysis in myocardial infarction, where the marked efficacy was been replicated in study after study, and was championed by Emergency Physicians. The situation in stroke is quite different. Brain is a very different substance to myocardium. The “very small number you may cause harm and cause a haemorrhage” (as Prof Gerraty describes it) are not minor events – we are talking about potentially lethal intracerebral bleeds. Because the infarcted tissue is in the brain, this is much more significant than the much smaller percentage of intracerebral bleeds from thrombolysis for AMI.
But it’s not just the haemorrhages.
The data so far just don’t show the type of efficacy many assume must be true for commentators like Richard Gerraty to say “the first step was for hospitals to acknowledge that rt-PA worked and then organise uptake of the treatment..”
But what if some people who have reviewed the data carefully, with no vested interests, don’t agree that it is proven to work? Should they be coerced into using it – or should the onus be on the proponents to come up with more convincing evidence?