(RxWiki News) Patients who receive brain stents after a stroke have a much higher chance of suffering another stroke or dying. Receiving aggressive medical therapy was found to be more than twice as effective.
The national clinical trial results had been expected since the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study was halted in April, earlier than anticipated, after five stroke-related deaths occurred in patients who received stents within a 30-day period.
"Ask your doctor about Wingspan stents following a stroke."
Tudor G. Jovin, director of the Stroke Institute at University of Pittsburgh Medical Center and a principal investigator of the UPMC study site, found that patients fared better with aggressive monitoring of blood pressure, diabetes, cholesterol, antiplatelet drugs including aspirin, a healthy lifestyle and smoking cessation.
The trial had enrolled only 59 percent or 451 of the 763 patients anticipated in enrolling in the two and a half year study. Those enrolled had experienced a non-disabling stroke caused by intracranial arterial stenosis within 30 days of beginning the trial, and were considered high risk patients.
Patients received aggressive monitoring and some were randomized to receive angioplasty to widen blood vessels in the brain and implantation of a stent to prop open the vessel.
However, 14.7 percent of patients in the angioplasty and stenting group experienced a stroke or died during trial enrollment in comparison to 5.8 percent in the group that received only aggressive monitoring. Over the course of the trial between November 2008 and April 2011, 33 patients had a second stroke or died within 30 days of joining the study versus 13 patients in the group that received only therapy.
A follow up period of less than a year showed that 21 percent of patients who received the Gateway-Wingspan stent, the only one approved for high risk stroke patients, had a stroke or died. About 12 percent from the medical group had another stroke or died.
Researchers had set out to show that stenting was superior to traditional medical therapy so investigators had been surprised by the results. The finding could have an impact on clinical practice, though brain stents could still be useful in some patients.
The study was funded through a research grant from the National Institute of Neurological Disorders and Stroke.
The study is published in the New England Journal of Medicine.