A study published in the September 7 issue of the New England Journal of Medicine, reporting on National Institutes of Health research on brain stents, explains that for high-risk stroke patients, aggressive medical treatment without stenting is better.

However, at Cedars-Sinai Medical Center specialists who were involved in the investigation believed that for certain patients this technique is suitable. The experts expressed concern that this report might discourage patients who may benefit from minimally invasive placement of either a mesh or stent to open blocked brain arteries. They explain that although this article is a useful start it is unlikely to be the final word on understanding when stenting may be suitable, thus raising concerns regarding many study limitations and exclusions.

Patrick D. Lyden, MD, chairman of the Department of Neurology and the Carmen and Louis Warschaw Chair in Neurology at Cedars-Sinai, an expert in the medical intervention and management of stroke, explains:

"Patients in the trial received aggressive management of their risk factors far greater than patients usually get. Only with such heroic measures will the average patient benefit the way those in the trial did."

Michael J. Alexander, MD, professor and clinical chief of the Department of Neurosurgery, and director of the Cedars-Sinai Neurovascular Center, says:

"For certain patients - particularly those for whom drugs are not effective - most experts believe stenting is a viable option. We have had many patients who have had dramatic, immediate improvement in neurologic function following intracranial stenting."

Lyden and Alexander, who led Cedars-Sinai's part of the 50-center clinical trial, expressed worries about this report, such as: Patients who are sicker, such as those with several blocked arteries or long-length blockages were not included, these are among patient more likely to benefit from stenting. The majority of patients in the investigation had blockages in smaller arteries, making it harder to treat with stenting. In clinical trials of interventional or surgical procedures, it is frequent for patients in the treatment arm to have a higher event rate in the first 30 days. More valid information is provided by long-term results. Alexander, a member of the initial NIH steering committee for this study, explained:

"Angioplasty and stenting procedures have become commonplace in treating blocked heart arteries, but stenting in the brain is more challenging because brain arteries are more delicate than those of the heart. The Wingspan stent - evaluated in the study - was designed to be more flexible to accommodate fragile brain arteries.

This is the first study which closely has analyzed longer-term patient outcomes with intracranial stenting. Initial studies with coronary (heart) artery stenting and carotid artery stenting also were not greatly successful. However, as we have been able to determine which patients are the best candidates for these treatments, and the technology has improved, they have become very successful. I believe the same will be true of intracranial artery stenting."

Alexander, a consultant and device proctor for Stryker Neurovascular, manufacturer of the Gateway balloon and Wingspan stent, has performed over 500 intracranial stenting procedures and was involved in primary testing of the device used in the investigation, the Gateway-Wingspan intracranial angioplasty and stenting system. Alexander has no other financial interest in the company.

The Food and Drug Administration have approved the device.

The New England Journal of Medicine article is on the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, funded by the National Institute of Neurological Disorders and Stroke, part of the NIH.

Grace Rattue

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