Patients at a high risk for a second stroke who received intensive medical treatment had fewer strokes and deaths than patients who received a brain stent in addition to the medical treatment, a large nationwide clinical trial has shown.
NewYork-Presbyterian Hospital and its two academic affiliates — Columbia University Medical Center and Weill Cornell Medical College — were part of the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial.
In total, 50 medical centers participated, led by the Medical University of South Carolina in Charleston.
According to the study authors, the SAMMPRIS results have immediate implications for clinical practice. Stroke patients with recent symptoms and intracranial arterial blockage of 70 percent or greater should be treated with aggressive medical therapy alone that follows the regimen used in this trial as closely as possible.
New enrollment in the study was stopped in April because early data showed significantly more strokes and deaths occurred among the stented patients at the 30-day mark compared with the group who received the medical management alone.
Half the patients in the study received a medical regimen that included daily anti-thrombotic medications and aggressive control of blood pressure and cholesterol. The other patients in the study received an intervention of a self-expanding stent that widens a major artery in the brain and facilitates blood flow.
One possible explanation for the higher stroke rate in the stented group is that patients who have had recent stroke symptoms sometimes have unstable plaque in their arteries that the stent could have dislodged, the study authors suggest.
The study device, the Gateway-Wingspan intracranial angioplasty and stenting system, is the only system currently approved by the U.S. Food and Drug Administration (FDA) for certain high-risk stroke patients.
The authors noted that although similar stenting systems that do not have FDA approval are being used in clinical practice, they did not evaluate those devices in this study.
The authors also emphasize that the study participants were in the highest risk category, with blockage or narrowing of arteries of 70 to 99 percent. Stroke patients with moderate cerebral arterial blockage (50 to 69 percent) were excluded because their risk of stroke is low with usual medical management, and researchers thought this group would be unlikely to benefit from stenting.
Source: Weill Cornell Medical College, USA