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Clinical benefits of endovascular therapy for acute ischemic stroke still unproven

MD-FM Thursday February 14, 2013




GENERIQUE
Carillon
 
Sarah:
MD FM — Medical News from around the world with Peter Goodwin.

P1

PETER:
Hello, and with me is Sarah Maxwell. To begin with, for patients who’d had a stroke, removing the arterial blockage with endovascular therapy made no difference. And that was whether this was done within the four and half-hour window of care or after – dashing hopes that a treatment already being adopted actually brings benefit. That’s according to one of three studies published in the New England Journal of Medicine — and presented at the International Stroke Conference just held in Hawaii…
 
SARAH:
Yes, for patients with moderate to severe stroke the study showed, endovascular therapy used together with intravenous thrombolysis wasn’t better than iv-thrombolysis alone! But lead author, Joseph Broderick, told us they found a trend relating to how soon they started the treatment:

Bob-Broderick: “It probably is going to be more effective if we can deliver it much more quickly than we are doing now. And... we didn’t have the newest devices called stent retrievers, which probably do open up the arteries better than the technologies for the most part that was used in the study. And so whether that would give us an ability to make a bigger difference... that’s something that needs to be tested in a trial.”

SARAH:
That was doctor Joseph Broderick, from the University of Cincinnati in Ohio. The second study in the New England Journal was a head-to-head trial, showing endovascular therapy alone — even when time-to-treatment was only one hour longer — didn’t improve outcomes compared to IV-thrombolysis…

PETER:
And the third study, I gather, looked at care beyond the four and a half-hour window, didn’t it?
 
SARAH:
Yes, well prior studies suggested a subset of patients: those with with favorable so-called penumbra patterns — showing up on brain imaging — might benefit from endovascular therapy. But these data also showed there was no advantage:
 
Bob-Broderick-2: “It kind of makes us re-examine some of the way we are thinking about using imaging to select out patients in the later time windows for treatment with thrombectomy devices. It’s a little bit sobering because there’s a number of trials that are ongoing that want to use these imaging technologies to select out patients so hopefully the field will learn from this and say why didn’t we find what we expected? And that’s a question that we are going to have to address.”

SARAH:
Doctor Joseph Broderick in the USA. And the New England Journal editorial raised the question of just how do you persuade anxious patients and doctors to refrain from using an appealing treatment for which there is little evidence of efficacy yet, but for which randomized clinical trials — in a challenging clinical situation — are very much needed!

VIRGULE MUSICALE
 
P2

PETER:
For patients with Parkinson’s disease, neuro-stimulation improved quality of life compared to medical therapy according to findings published in the New England Journal of Medicine…
 
SARAH:
Yes, deep brain stimulation — added to usual care medication —  dramatically reduced motor disabilities in patients with early motor complications compared to using drugs alone.

PETER:
Hmm this sounds encouraging, but what about adverse events? How safe was this approach?

SARAH:
Well, adverse events were mostly mild, but they were more frequent with neuro-stimulation. Out of 250 patients there were three suicides and four suicide attempts – but these were distributed equally across both arms of the study:

Bon-Deuschl-1: “In the past, people always thought that DBS is causing suicidality --this is obviously not the cause since we had it in both treatment arms. It is much more likely that this kind of treatment selects those subjects who are later at risk to commit suicide. So people who are willing to undergo this treatment should have a very detailed explanation on what the treatment is.”  
 
SARAH:
That was lead study author Günther Deuschl, from Kiel in Germany.
 
PETER:
At the moment, guidelines suggest giving DBS much further down the road, when medication can no longer improve a patient’s status don’t they?

SARAH:
Well, yes but these new data suggest you can bring a lot of benefit by using it sooner — fuelling the debate on when is best to start treatment…
 
Bob-Deuschl-2: Now there will be a discussion process on how early one should offer this treatment to patients with Parkinson’s disease. In my view one should offer it definitely much earlier than we did before. I would at least offer it to younger people because the side effects are less than in the elderly population.”

SARAH:
Professor Günther Deuschl, from Germany.


VIRGULE MUSICALE
 
P4

PETER:
Expectant mothers who take folic acid supplements, from around the time of conception can lower their baby’s risk of autistic disorder by 40% according to a population-based study published in JAMA...

SARAH:
Yes, it looked at over 85,000 children and showed there was a lower risk of autistic disorder when mothers took folic acid early on — beginning four to eight weeks after the start of the mother’s last period: which the investigators defined as the time of conception:
 
Bob-Suren: “We haven’t strictly speaking proven that folic acid is preventive against autism but our results indicate that there’s a very good chance that it might be preventive and that this provides an additional reason for women to take folic acid supplements during pregnancy. And the fact that the association is limited to those who took it in early pregnancy underlines the importance of starting as early as possible and preferably before the pregnancy has started.”

SARAH:
That was lead study author doctor Pal Suren from the Norwegian Institute of Public Health, who said they didn’t find any association with atypical and unspecified autism, and an analysis was too early to establish a connection with Asperger syndrome.
 
PETER:
But previous data have highlighted the benefit of folic acid haven’t they — in 2011 one study showed, the children of women who took vitamin supplements containing folic acids had a lower risk of autism didn’t they?…

SARAH:
Yes however, those data weren’t able to tell if the benefit was from folic acid, vitamins or minerals. So this is the first study looking at folic acid specifically.

VIRGULE MUSICALE

P5

PETER:
For patients with heart disease, substituting saturated animal fats with poly-unsaturated fatty acids, increased their risk of death in a study reported by the British Medical Journal…

SARAH:
Yes, patients who were randomized to have safflower oil — a concentrated form of omega-6 linoleic acid — had a higher risk of cardiovascular disease and of death from all-causes, according to an updated meta-analysis and recovered data from the Sydney Diet Heart Study.

PETER:
And this is the second time the BMJ investigators have reported findings like these isn’t it and it’s causing quite a stir…

SARAH:
Well, yes as these data raise questions about the long-established knowledge and advice given on dietary fats and heart disease. Philip Calder from the University of Southampton wrote an editorial on the study:

Bob-Calder: “I think we shouldn’t just on the basis of this one study turn everything around --I don’t think any doctor should say to their patient ‘you should stop using margarine and go back to using butter’ for example, but we just need to realize that things are not quite as clear as everybody has thought and we need to look a little bit more carefully at the data that are there and just be more cautious.”

SARAH:
Professor Philip Calder added that, 16% of energy intake for patients randomized to replace saturated fats, were from linoleic acids:

Bob-Calder: “Now in the European context, that’s quite high. In the UK for example there would be very few people who eat more than 10% of energy from linoleic acid but in the United States, there are already people who are eating these very high intakes so I think we have to take that into consideration.”

SARAH:
Professor Philip Calder, from the UK.


BREVE 1 Sur fond musical
 
PETER:
Finally, in brief:

Work-related stress and job strain is unlikely to be an important risk factor for: colorectal, lung, breast or prostate cancers. That’s from a meta-analysis — published in the British Medical Journal — that looked at 12 European cohort studies, with nearly 120,000 men and women free from cancer at study entry, and followed them up for a median of 12 years.

And...

BREVE 2

Diclofenac, is one of the most commonly used non-steroidal anti-inflammatory drugs — or NSAIDS — but it’s on the ‘essential medicines’ list of 74 countries, despite being known to cause heart attacks and strokes in vulnerable patients. Authors of the study reporting this —  in PLOS Medicine — say the cardiovascular risk is almost identical to that of Vioxx, which was withdrawn from worldwide sales in 2004.

That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then from me Peter Goodwin, goodbye!
 
JINGLE FIN     
 

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