Intracranial Stenting Not Recommended Outside Clinical Trial SettingOct 25, 2013
Patients who undergo an intracranial stent procedure outside of a clinical trial are more likely to suffer life-threatening complications or death than patients who undergo the same procedure as part of a clinical trial.
The Cardiovascular Research Foundation says that a clinical trial investigating the outcomes of intracranial stenting had to be stopped early due to a high rate of complications in patients who underwent the procedure outside the trial setting. One expert reported for the trial's findings that intracranial stenting, at least for now, should be limited to a clinical trial setting.
Research for the study was conducted by the University of Minnesota. The study examined the results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial, which was stopped early due to the high rate of complications. The study included more than 3,400 ischemic stroke patients who had undergone intracranial stenting either in- or outside of the SAMMPRIS clinical trial.
In addition to the higher rate of complications experienced by the patients who underwent intracranial stenting outside of the trial setting, those who did receive the procedure in the trial had better outcomes, including shorter hospital stays after the procedure and a significantly greater chance of being released to their homes instead of a nursing home or rehabilitation facility, according to the Cardiovascular Research Foundation.
As part of the study, researchers found that 9.6 percent of patients receiving intracranial stenting died following the procedure within a 30-day window. That compared to 4.5 percent of patients who underwent the procedure as part of a clinical trial. Only half the patients outside the trial were discharged from the hospital to their own homes, compared to nearly 77 percent participating in the trial.
Forty percent of patients undergoing intracranial stenting were discharged to a nursing home or rehabilitation facility if they received the procedure outside the trial setting. That compares to just 18.7 percent who participated in the trial.
Also, hospital stays were about half the time for intracranial stent patients who participated in a clinical trial.