Friday, September 09, 2011

STENTING FOR INTRACRANIAL STENOSIS DOES WORSE THAN AGGRESSIVE MEDICAL THERAPY IN STROKE PREVENTION.

Attention all neuro-interventionist and patients with strokes and TIAs.
The latest issue of New England Journal Of Medicine ( Sept 7th ) carries an article by Dr Marc Chimowitz on the results of SAMMPRIS ( Stenting and Aggressive Medical Management for Preventing Recurrent Strokes in Intracranial Stenosis trial. Dr Chimowitz is from the Medical University of South carolina, and the trial is sponsored by the national Institute of Neuro disorders and stroke ( a government funded institution ).
Dr Chimowitz and colleagues enrolled patients with history of TIA or stroke, with 70-99% intracranial vessel stenosis, randomised them into aggressive medical management only versus aggressive medical management with intracranial angioplasty with stenting using the Wingspan system.
They found that as they enrolled patients, enrollment has to be stopped in April 2011 ( 451 patients enrolled ), when the safety review committee discovered that the intervention arm ( after 30 days follow-up ) had significantly more events and complications than the aggressive medical arm. This trial was scheduled to enroll 750 patients with two years follow-up. Their primary endpoint was of course re-stroke or death, and secondary endpoint was recurrent stroke or TIA.
We learn a few lessons here. We learn that such important trials are better funded by National public bodies ( if they can afford it ) , and not by industry. We also learn that over the years, intensive medical therapy for atherosclerosis and athero-thrombosis, has progress by leaps and bounds. Intracranial intervention, is much more tricky then extracranial interventions and carries a higher risk and complications. The trial reported a 30% incidence of cerebral hemorrhage and vessel perforations.
This is the third such trial to show this result. The other two also had similar outcomes, telling us that intracranial stenosis should be left alone on intensive medical therapy.
But then, this means that the interventionist cannot " dilate for bread". Just too bad.

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