Intensive medical treatment prevents second stroke not intra cranial stenting

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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. The investigators published the results in the online first edition of the New England Journal of Medicine.

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, funded the trial. The medical regimen included daily blood-thinning medications and aggressive control of blood pressure and cholesterol.

New enrolment 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 to the group who received the medical management alone.

In addition to the intensive medical program, half of the 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 which 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 study participants were in the highest risk category, with blockage or narrowing of arteries of 70 to 99 percent.

Intensive medical management included a daily dosage of 325 milligrams of aspirin; 75 milligrams a day of Clopidogrel, for 90 days after enrollment; and aggressive 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, and controlling diabetes and cholesterol.

“The SAMMPRIS study 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.

[New England Journal of Medicine, published online September 7, 2011].