Stroke is the fourth leading cause of death in the United States and is often the result of blood vessel narrowing due to buildup of cholesterol in brain blood vessels. A new report, published in Lancet, details long-term outcomes of a study that compared aggressive medical therapy with surgically implanted stents to open narrowed brain blood vessels for the prevention of stroke. This clinical trial was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
Patients who had recently experienced a stroke or a stroke warning sign due to stenosis of blood vessels inside the head were randomized to receive aggressive medical therapy alone (anti-clotting medications, control of risk factors such as blood pressure and cholesterol, and a lifestyle modification program) or aggressive medical therapy plus a brain stent (a mesh implant that keeps the affected blood vessel open). Enrollment in this study was stopped in April 2011, which was earlier than planned due to safety concerns after researchers found that stents were associated with a high risk of early stroke and death. In addition the stroke rate in those treated with aggressive medical therapy was lower than expected. Patients continued to be followed for two years to see if prior opening of the narrowed artery with a stent decreased long-term stroke risk.
The new 32-month analysis did not indicate that stenting provided a benefit over longer time periods in study participants. During the follow-up period, the rate of stroke was not lower in the group treated with a stent than in the group that received aggressive medical treatment alone. The authors noted that the novel medical approach consisting of combining anti-clotting medications, controlling risk factors and adopting a healthy lifestyle (exercise, smoking cessation, healthy diet) likely contributed to lower than expected rates of stroke. Of note in this trial, the percentage of treated patients who achieved normal blood pressure levels was 70% and 62% achieved normal lipid levels. These findings of lower stroke risk with aggressive medical management have important clinical implications for stroke prevention.