News : 2016 : April

Two National Stroke Studies Shed Light on Treatment Options for Carotid-Artery Stenosis

Two national studies published in The New England Journal of Medicine have found little long-term difference between leading treatment options for reducing the risk of stroke from carotid-artery stenosis. A researcher at UHealth – the University of Miami Health System participated in the two clinical trials comparing the effectiveness of inserting a stent versus endarterectomy.

“Most stroke studies involving surgical procedures focus on short-term outcomes because any serious problems usually occur within 10 days after a procedure,” said Seemant Chaturvedi, M.D., professor of clinical neurology and vice chair for VA Programs in the Department of Neurology at UHealth. “These clinical trials looked at the results in at-risk patients after one and 10 years and found little difference between the two options.”

“Now, we have begun to enroll patients in a new NIH-funded clinical trial at UHealth involving the use of medications to stabilize clogged carotid arteries — a third treatment option for at-risk patients,” said Chaturvedi.

The first published study, “Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis,” analyzed the outcomes for 2,502 patients at 117 centers that participated in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). A prior study had found no significant differences in respect to the risk of periprocedural stroke, myocardial infarction, or death up to four years after the procedures, and this study extended those results to 10 years. The study was funded by the National Institutes of Health and Abbott Vascular Solutions.

The second study, “Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis,” compared carotid-artery stenting with embolic protection and carotid endarterectomy in patients age 79 or younger. It focused on the results of the Asymptomatic Carotid Trial (ACT), which involved 1,453 patients with carotid-artery stenosis of greater than 60 percent of the diameter of the artery. The trial was funded by Abbott Vascular Solutions.

“The results of the ACT clinical trial showed that endarterectomy was about 1% better than stenting at 30 days, but this was not statistically significant after 12 months,” Chaturvedi said. “Also, at five years there was no statistical difference.”

The next step will be testing revascularization versus aggressive medical therapy. This is being done in the CREST 2 study, and UHealth physicians are trying to identify patients with 70-99 percent carotid narrowing and no stroke symptoms for at least six months.

CREST 2 is being conducted as part of the NIH Stroke Trials Network, with UHealth serving as one of 25 regional coordinating centers for the network. The effort in the Stroke Trials Network is led by Jose G. Romano, M.D., professor of clinical neurology at UHealth, chief of the Stroke Division, and medical director of the Jackson Memorial Hospital Comprehensive Stroke Program, and Ralph L. Sacco, M.S., M.D., professor and chair of the Department of Neurology at UHealth, and Olemberg Family Chair of Neurological Disorders.

For more information about UHealth Clinical Trials visit uhealthsystem.com/clinical-trials.