Findings in a major clinical trial led by MUSC researchers have redirected the way doctors may now treat stroke patients– and will save lives.
Thanks to the study, published in the upcoming New England Journal of Medicine, physicians now have evidence that aggressive medical therapy is safer and more effective than placing a stent in the brain to ward off a second stroke in certain high-risk patients.
The trials addressed treating stroke patients with stenosis, a blockage or narrowing of a brain artery caused by the build up of plaque, which accounts for more than 50,000 of the 795,000 strokes that occur annually nationwide.
AUDIO: Listen to entire interview with Dr. Chimowitz
This particularly resonates in South Carolina, the “buckle of the stroke belt,” which runs through the American South.
MUSC’s Marc Chimowitz was lead investigator of this nationwide clinical trial. He’s a neuroscientist and a SmartState endowed chair. He says the trial was so decisive that it was halted early. The National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH (National Institutes of Health) and which funded the trial, stopped the study because early data showed significantly more strokes and death among stented patients at the 30-day mark when compared to the group who received aggressive medical management alone.
While that typically is not good news for a lead researcher to hear, Chimowitz says, “The part that turned out to be good news in this trial was that is was not just because stenting was unsafe, but because the medical patients had done so much better than we thought we were going to do.”
The stent under trial had been approved by the FDA for patients with stenosis, who were also already on certain medications. Some private insurers were also paying for the stent procedure. Medicare wanted to see evidence that it was beneficial before permitting its use.
“This study provides an answer to a longstanding question by physicians, what to do to prevent a devastating second stroke in a high risk population, “said Walter Koroshetz, NINDS deputy director.
Proving that an FDA-approved practice was unsafe “has enormous impact, ” says Chimowitz.
In this trial, “aggressive medical management ” included using two blood-thinners and what is commonly known as Plavix along with a protocol-driven risk-factor management scheme.
This trial is unique, however, researchers also incorporated “lifestyle modification programs” — healthier behaviors– as a component of managing the medical risk. This includes quitting smoking, increasing exercise, weight loss in overweight patients, healthy diet, and controlling risk factors such as diabetes, high blood pressure and cholesterol.
This combination proved significantly safer than invasive treatment says Chimowitz.
Success of this scope elevates MUSC and makes the case for further research funding. This $26 million trial could bring up to $5 million back to the school and state, through direct and indirect funding.
Stenosis is particularly common in African-Americans, Hispanics, Asian Americans, and people with diabetes.