Feature | September 08, 2011

NIH Study: Brain Stents Cause More Strokes, Medical Therapy More Effective

September 8, 2011 – 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. 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 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 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 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 (50-69 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.

"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 practice, we have now learned that, when tested in a large group, this particular device did not lead to a better health outcome," said Walter Koroshetz, M.D., deputy director of NINDS.

Stroke is the fourth leading cause of death in the United States. Stenosis, a blockage or narrowing of brain arteries 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 NIH Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study enrolled 451 patients at 50 sites across the United States. 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 intensive medical therapy alone, the addition of an intracranial stenting system would decrease the risk of a 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. During a follow-up period of just less than one year, 20.5 percent of patients in the stenting group and 11.5 percent of patients in the medical group had a stroke or death, or a stroke in the same area of the brain beyond 30 days, a highly significant difference in favor of the patients in the study’s medical group. Based on these data, the Data and Safety Monitoring Board recommended that the NINDS stop new enrollment, and the NIH issued a clinical alert. All patients will continue to be followed for two years to determine the long-term effects of both interventions.

SAMMPRIS is the first stroke prevention trial to compare intracranial stenting with medical therapy and to incorporate intensive medical management into the study design. This includes 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 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.

In a previous NIH trial, stroke patients with criteria similar to those enrolled in SAMMPRIS were treated with less intensive medical management. Their comparable 30-day and one year rates were 10.7 percent and 25 percent, respectively. The investigators note that comparisons with historical controls have limitations, but the much lower event rates in the medical group in SAMMPRIS suggest that the intensive medical management was effective in lowering the stroke risk.

"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 that follows the regimen used in this trial as closely as possible," said Marc Chimowitz, M.B.Ch.B., of the department of neurosciences at the Medical University of South Carolina in Charleston, and first author of the NEJM article.

Patients in the study were between 30 and 80 years old and had experienced a recent transient ischemic attack, a type of stroke that resolves within 24 hours, or another type of non-disabling stroke, which was caused by a large degree of stenosis in a cerebral artery.

NINDS is the nation's leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease—a burden borne by every age group, by every segment of society, by people all over the world.

About the National Institutes of Health

The NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

For more information: www.nih.gov


Reference: Chimowitz MI, Lynn, MJ, Derdeyn CP, Turan TN, Fiorella D, Lane, BF, Janis, S, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson, MD, Pride, GL, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ, for the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. “Stenting Versus Aggressive Medical Therapy for Intracranial Artery Stenosis.” New England Journal of Medicine, published online September 7, 2011.

Related Content

stroke risk
News | Clinical Study| August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Stent graft, computational fluid dynamics, CFD, stent engineering

In this vector velocity model, brighter colors indicate blood flow acceleration as it passes through a bifurcation. Computation fluid dynamic modeling provides insight on blood flow through and near the walls of the stent graft. Image courtesy of Sanford Health

News | Cath Lab| August 27, 2015
August 27, 2015 — The use of computational fluid dynamics (CFD) modeling has been used for years to better engineer l
News | Cath Lab| August 26, 2015
August 26, 2014 — The Cardiovascular Research Foundation (CRF) announced the late-breaking trials and first report in
BioSig Technologies, research agreement, UCLA, Pure EP System, EP lab, ventricular tachycardia model, VT
Technology | EP Lab| August 20, 2015
BioSig Technologies announced it has signed a sponsored research agreement with the regents of the University of...
Sunshine Heart, COUNTER HF pivotal study, resumes enrollment, C-Pulse, FDA
News | Heart Failure| August 18, 2015
Sunshine Heart Inc. announced an update in late July on its COUNTER HF U.S. pivotal study for the C-Pulse Heart Assist...
Biotronik, BioCONTINUE study, CRT-D, defibrillator, cardiac resynchronization therapy device, heart failure, first replacement
News | Cardiac Resynchronization Therapy Devices (CRT)| August 17, 2015
Biotronik announced that the first patient has been enrolled in the BioCONTINUE clinical trial (BIOtronik study to...
global interventional cardiology devices market, worth, Grand View Research, stents, catheters
News | Cath Lab| August 17, 2015
The global interventional cardiology devices market is expected to reach $25.16 billion by 2020, according to a new...
Medtronic, Endurant Evo AAA, stent graft system, first European cases
News | Stent Grafts| August 13, 2015
Medtronic plc announced that the first two European patient cases with the Endurant Evo AAA stent graft system were...
zebrafish, iWorx Systems Inc., ZS-200 Zebrafish ECG System, cardiac research
Technology | ECG| August 13, 2015
iWorx Systems Inc., developer of advanced physiology teaching and research instruments and software, has introduced a...
NICE, U.K., edoxaban, Lixiana, VTE, venous thromboembolism, deep vein thrombosis, pulmonary embolism
News | Deep Vein Thrombosis| August 12, 2015
The National Institute for Health and Care Excellence (NICE) has recommended a new treatment to help patients suffering...
Overlay Init