Sept. 7, 2011
CHARLESTON -- 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 high-risk patients with a narrowed brain artery.
Results from a 50-center nationwide clinical trial spearheaded by lead investigator Marc Chimowitz, MBChB, Medical University of South Carolina (MUSC) Neurosciences professor and SmartState endowed chair, have shown that aggressive medical management alone is superior to aggressive medical management combined with a specific type of brain stent for patients at high risk for stroke. Investigators published the results from the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial in this week’s issue of the New England Journal of Medicine.
“There were two surprising findings in this study,” Chimowitz said. “First, stents did not perform as well as we had anticipated which has important implications for clinical practice because stenting is increasingly being used to treat these patients worldwide. The second surprising finding was the large gains demonstrated through the use of aggressive medical therapy on its own. This is the first stroke-related trial to include lifestyle change therapy and protocol-driven management of multiple risk factors such as high blood pressure and raised cholesterol,” he said. “Based on the results of this study, 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.” The National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH (National Institutes of Health) and which funded the trial, halted new enrollment in the study in April 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.
“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. Although technological advances have brought intracranial stenting into widespread practice, we have now learned that this particular device does not lead to a better health outcome,” said Walter Koroshetz, M.D., NINDS deputy director.
Stroke is the fourth leading cause of death in the US. Stenosis, a blockage or narrowing of a brain artery caused by the build up of plaque, accounts for more than 50,000 of the 795,000 strokes that occur annually nationwide. Stenosis is particularly common in African Americans, Hispanics, Asian Americans, and people with diabetes.
The SAMMPRIS study enrolled 451 patients at 50 sites across the US. The investigators looked at whether patients had a second stroke or died within 30 days of enrollment, or had a stroke in the same area of the brain from 30 days to the end of follow-up. They had hypothesized that compared to aggressive medical therapy alone, the addition of intracranial stenting system would decrease the risk of stroke or death by 35 percent over two years.
Instead they found that 14.7 percent of patients (33) in the stenting group experienced a stroke or died within the first 30 days after enrollment, compared with 5.8 percent (13) of patients treated with medical therapy alone. There were five stroke-related deaths within 30 days, all in the stenting group, and one non-stroke related death in the medical management group. Over a mean follow-up of 11.9 months, 20.5 percent of patients in the stenting group and 11.5 percent of patients in the medical group had a study primary endpoint (stroke or death within 30 days or stroke in the same area of brain beyond 30 days), which demonstrates a highly significant difference in favor of the aggressive medical management on its own. Based on these data, the Data and Safety Monitoring Board recommended the NINDS stop new enrollment, and the institute issued a clinical alert. All patients will continue to be followed for two years to determine the long-term effects of both interventions.
Aggressive medical management is defined as:
• a daily dosage of 325 milligrams of aspirin;
• 75 milligrams a day of clopidogrel, a medication used to prevent blood clots, for 90 days after enrollment; and
• intensive management of key stroke risk factors- high blood pressure and high levels of low density lipoprotein (LDL), the unhealthy form of cholesterol.
All patients also participated in a lifestyle modification program which focused on quitting smoking, increasing exercise, weight loss in overweight patients, healthy diet, and controlling risk factors such as diabetes, high blood pressure and cholesterol. With aggressive medical management, the medical group in this trial had a 30-day rate of stoke of death of 5.8 percent and a one year primary endpoint rate of 12.2 percent. In comparison, patients in a previous NIH trial with similar entrance criteria to SAMMPRIS who were treated with less intensive medical management had a 30-day rate of stroke and death of 10.7 percent and a one year rate of primary endpoint of 25 percent, suggesting that the aggressive medical management in this trial was effective in lowering the risk of stroke.
For more data and study details, visit the New England Journal of Medicine’s website: http://www.nejm.org/doi/full/10.1056/NEJMoa1105335
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