Dr. Philip Meyers from the Endovascular Center has joined his colleagues in taking another look at the 2011 SAMMPRIS trial. SAMMPRIS, short for Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke, was a large multi-center trial that compared two methods of stroke prevention; medical therapy, and angioplasty with stenting.
The patients enrolled in the study had all previously survived a stroke or mini-stroke and were at high risk for having another. During the SAMMPRIS trial, these patients received intensive medical management including daily blood thinning medication, and aggressive control of blood pressure and cholesterol.
Half of the group also underwent angioplasty with stenting: Angioplasty is a minimally invasive procedure done to re-open severely narrowed blood vessels via an artery in the leg; and stenting involves the placement of a mesh tube, in this case the Wingspan™ system, to widen the narrow vessel and improve blood flow to the brain.
Researchers were surprised by the trial’s results: those patients solely on medical therapy did significantly better than those who also received the stent.
“Although we at Columbia didn’t experience the problems stenting patients that occurred in the overall trial population, multi-center trial data is most important,” says Dr. Meyers, who was the trial’s principle interventional investigator here at Columbia. “The patients we treated did well. We all thought that stenting was going to be the best thing to do for these patients, but the results of the overall trial showed that it is not–medical therapy was found to be superior in SAMMPRIS.”
Because of these results, Dr. Meyers and his colleagues decided to look more closely at the SAMMPRIS data. They wanted to see if factors specific to the facilities and interventionists involved in the trial correlated with the results of the angioplasty and stenting results. They reviewed study records for procedures performed by 63 interventionists at 48 sites.
In particular, the authors reviewed the number of procedures performed at each site and the level of experience that each interventionist had with the Wingspan™ system. The authors concluded that the level of experience with the Wingspan™ system was not responsible for an increased recurrance of stroke in the angioplasty-with-stenting group. “Hemorrhagic stroke may be related to low enrollment in the trial,” they said, “but not previous Wingspan experience.”
“This is important information,” says Dr. Meyers. “As physicians, we want what is best for our patients. Scientific progress is not always simple or easy. There are many technological developments in the treatment of cerebrovascular diseases. We have to know what works and what does not to deliver excellent medical care.”
Their results were published online for early review in the Journal of NeuroInterventional Surgery. The article is titled, Impact of operator and site experience on outcomes after angioplasty and stenting in the SAMMPRIS trial (read the article online here).
“We are not entirely sure why patients in the medical arm of SAMMPRIS did so well,” says Dr. Meyers. “We, therefore will continue to review the data and investigate further.”
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