JACKSONVILLE, Fla. — A major international study led by Mayo Clinic researchers and funded by the National Institutes of Health found that for people with severe carotid artery narrowing who haven't experienced recent stroke symptoms, a minimally invasive procedure called carotid artery stenting, combined with intensive medical therapy, significantly lowered stroke risk compared with medical therapy alone. Traditional surgery (carotid endarterectomy) did not show the same benefit. The research is published in The New England Journal of Medicine.

The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is the largest study to date comparing current treatment approaches for this condition, caused by plaque buildup in the arteries supplying blood to the brain.

Carotid stenosis can lead to a stroke if plaque breaks off and blocks blood flow. Although surgery and stenting have long been used to open these arteries, newer medications and better risk factor control have raised questions about whether these procedures are still needed for people who don't have symptoms.

"Decades ago, surgery clearly helped prevent strokes in many patients," says Thomas Brott, M.D., a neurologist at Mayo Clinic in Florida and the study's senior author. "But medical therapy has improved so much that we needed to reexamine the balance between benefit and risk for people who have no symptoms."

The CREST-2 program consisted of two parallel, randomized clinical trials conducted at 155 medical centers in five countries, including Australia, Canada, Israel, Spain and the U.S. Each enrolled more than 1,200 adults with severe carotid artery narrowing of 70% or greater who had not had a stroke or transient ischemic attack (ministroke) in the past six months.

In one trial, participants received stenting plus intensive medical therapy or medical therapy alone. In the other, participants received endarterectomy plus medical therapy or medical therapy alone.

All participants received comprehensive medical care, including lifestyle coaching and medication as needed, to manage their blood pressure, low-density lipoprotein (LDL) cholesterol and diabetes, and to help them stop smoking.

Working with investigators from the University of Alabama at Birmingham, researchers analyzed the occurrence of stroke and death within 44 days of stenting or surgery. They also analyzed the occurrence of stroke over four years on the same side of the body as the narrowed artery.

The stenting trial found a significant reduction in stroke: over four years, 2.8% of patients treated with stenting and medical therapy had a stroke compared to 6% of those on medical therapy alone (roughly half the risk of stroke). However, in the endarterectomy trial, the difference in stroke rates (3.7% with surgery vs. 5.3% with medical therapy alone) was not statistically significant. Serious complications were uncommon with either procedure.  

The findings provide clearer guidance for physicians and patients considering a preventive procedure. Dr. Brott emphasizes personalized decision-making.

"For some patients — particularly those with more advanced narrowing or plaque that appears unstable or more likely to cause a blockage — stenting may offer added protection, while for others, medical therapy alone may be enough," he says.

Close follow-up and coordinated care helped all participants achieve and maintain significant improvements in their blood pressure and cholesterol levels.

Researchers will continue to track participants for long-term results. They are also studying whether imaging tools can help identify which patients benefit most from each treatment.

For a full list of authors and disclosures, see the paper.

Related: Mayo Clinic Neurologists Lead International Study to Test Best Approach to Stroke Prevention

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To reduce the risk of a devastating stroke, each year as many as 100,000 people in the U.S. — and many more worldwide — with narrowing in a carotid artery undergo preventive treatment. One procedure, known as carotid endarterectomy, is a surgical operation to remove built-up plaque in the artery of the neck. A less invasive approach, introduced in the 1990s, is carotid artery stenting, which involves the insertion of a wire mesh that widens the artery to improve blood flow.

An international research team compared the long-term results of the surgical approach and stenting. In Lancet Neurology, the team reported both options reduce the risk of stroke — even 10 years after the procedure. “This was the largest study to date comparing the efficacy and durability of carotid surgery and carotid stenting,” says the study’s first author, Dr. Thomas Brott, a neurologist on Mayo Clinic’s Florida campus. “We found the likelihood of having a stroke on the same side where treatment was performed — even years later — to be remarkably low.”

That’s important, he adds, because the typical patient with a narrowed carotid artery is 70 years old. Life expectancy is another 16 years for women and another 14 years for men.

The study followed 4,754 patients in 19 countries. Those patients, who were participants of previous studies comparing the two procedures, had been assigned randomly to undergo endarterectomy or stenting. One of those studies was the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), led by Mayo Clinic. Another was the International Carotid Stenting Study, led by University College London.

“These trials had similar designs, which allowed us to combine the data with two other trials from France and Germany, to answer important questions concerning stroke treatment,” says Dr. Martin Brown from University College London in England, neurologist and corresponding author of the Lancet Neurology paper.

The research team followed patients’ outcomes for up to 10 years after the procedures and found the long-term rate of stroke following either procedure was as low as 0.6 percent per year. “Very low rates of stroke held up whether patients were male or female, old or young, smokers or nonsmokers,” notes Dr. Brott.

The team also compared the incidence of stroke in the immediate days and months after treatment, a period of time when patients are at risk of a poor result due to the risks of surgery or stenting. The researchers found endarterectomy to have better post-procedure results. However, Dr. Brott notes that several factors, including stenting technology and proper patient selection, have continued to improve over the years since patients in the current study had their procedures. He anticipates short-term outcomes of stenting could soon match those of surgery.

“Our studies have found patients over 70 and those with very hardened or very tortuous arteries tend to do better with surgery than with stenting,” he says. “There’s better information available now to match the right treatment to each patient.” Dr. Brott has been honored three times with awards by the American Heart Association, most recently the 2017 Research Achievement Award, for his research and work in revolutionizing treatment of ischemic stroke.

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On this week's Mayo Clinic Radio program, Dr. Clifford Jack Jr., a radiologist at Mayo Clinic, will explain the importance of the new Alzheimer's framework for improving research. Also on the program, Vivien Williams, medical reporter with the Mayo Clinic News Network, will discuss "Health + Happiness With Mayo Clinic," the weekly program she co-hosts on NBC. And Dr. Thomas Brott, a neurologist at Mayo Clinic, will look back the advances he's seen in his 40 years of treating stroke.

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On this week's Mayo Clinic Radio program, Dr. Clifford Jack Jr., a radiologist at Mayo Clinic, will explain the importance of the new Alzheimer's framework for improving research. Also on the program, Vivien Williams, medical reporter with the Mayo Clinic News Network, will discuss "Health + Happiness With Mayo Clinic," the weekly program she co-hosts on NBC. And Dr. Thomas Brott, a neurologist at Mayo Clinic, will look back the advances he's seen in his 40 years of treating stroke.

To hear the program, find an affiliate in your area.

Use the hashtag #MayoClinicRadio, and tweet your questions.

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Access archived shows or subscribe to the podcast.

Mayo Clinic Radio produces a weekly one-hour radio program highlighting health and medical information from Mayo Clinic.

The post Mayo Clinic Radio: Redefining Alzheimer’s disease appeared first on Mayo Clinic News Network.

On this week's Mayo Clinic Radio program, Dr. Clifford Jack Jr., a radiologist at Mayo Clinic, will explain the importance of the new Alzheimer's framework for improving research. Also on the program, Vivien Williams, medical reporter with the Mayo Clinic News Network, will discuss "Health + Happiness With Mayo Clinic," the weekly program she co-hosts on NBC. And Dr. Thomas Brott, a neurologist at Mayo Clinic, will look back the advances he's seen in his 40 years of treating stroke.

To hear the program, find an affiliate in your area.

Miss the show?  here's your Mayo Clinic Radio podcast.

Use the hashtag #MayoClinicRadio, and tweet your questions.

Mayo Clinic Radio is on iHeartRadio.

Access archived shows or subscribe to the podcast.

Mayo Clinic Radio produces a weekly one-hour radio program highlighting health and medical information from Mayo Clinic.

The post Mayo Clinic Radio: Redefining Alzheimer’s disease / ‘Health + Happiness With Mayo Clinic’ / 40 years of stroke treatment appeared first on Mayo Clinic News Network.

“Dr. Brott has devoted his life to taking crucial questions raised in the clinical setting and finding answers through groundbreaking research discoveries that have been translated into better treatment for patients everywhere,” says Gianrico Farrugia, M.D., vice president, Mayo Clinic, and CEO of Mayo Clinic in Florida. “Dr. Brott exemplifies Mayo Clinic’s approach to biomedical research, and we are very proud of him for providing patients with hope and answers.”

Dr. Brott’s wide-reaching research has focused on various aspects in the treatment of stroke. The American Heart Association gave the honor to Dr. Brott “for his pivotal role in the development of lifesaving interventions that have revolutionized treatment of acute ischemic stroke, with enormous consequent benefits dramatically reducing stroke death and disability in the world’s population.”

According to John Warner, M.D., president, American Heart Association, “Dr. Brott has been at the forefront of an international medical revolution in dealing with stroke, a worldwide health scourge that is a major cause of death and disability that annually afflicts nearly 17 million individuals—more than 6 million of whom die.”Dr. Brott was a leading investigator in the early studies that identified tissue plasminogen activator (t-PA) as an effective treatment for acute ischemic stroke. He played a key role in designing the National Institutes of Health Stroke Scale, a quantitative rating still used in hospitals and clinics worldwide to measure neurologic deficits in stroke patients. His studies also looked at intracerebral hemorrhage and determined that the bleeding in the brain often continues during the first minutes and hours, offering opportunities for urgent treatment.

His work also investigated the efficacy and complication rates of various stroke treatments, including looking at complications rates of the surgery known as endarterectomy, which prevents strokes by widening arteries to the brain. In recent years, Dr. Brott has served as principal investigator for major multi-institutional clinical studies, comparing two major treatments for stroke. He developed and led the Carotid Revascularization Endarterectomy versus Stenting Trial (known as CREST), which followed patients at more than 100 medical centers throughout treatment and 10 years afterward.

“Mayo Clinic is extremely proud of Dr. Brott and his pioneering contributions to research in stroke and cerebrovascular disease,” says Tushar Patel, M.B., Ch.B., dean for research at Mayo Clinic’s Florida campus. “His research has transformed the practice of medicine and has resulted in very significant advances in patient care.”

The American Heart Association’s Scientific Sessions is the leading cardiovascular meeting for the nation’s researchers and clinicians. Four other Mayo Clinic scientists have received the award since its inception in 1953.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, comprehensive care to everyone who needs healing. For more information, visit mayoclinic.org/about-mayo-clinic or newsnetwork.mayoclinic.org.

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JACKSONVILLE, Fla. — Stenting and surgery are equally effective at lowering the long-term risk of stroke from a narrowed carotid artery, according to results of CREST – a 10-year, federally funded clinical trial led by researchers at Mayo Clinic’s campus in Florida. The results are being published today online in the New England Journal of Medicine and presented at the American Heart Association’s International Stroke Conference in Los Angeles.

One of the largest randomized stroke prevention trials ever, CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) conducted a study of 2,502 patients with an average age of 69 for up to 10 years at 117 centers in the U.S. and Canada. The centers were coordinated through Rutgers-New Jersey Medical School, and the patient results were analyzed at the University of Alabama at Birmingham.

MEDIA CONTACT: Kevin Punsky, Mayo Clinic Public Affairs, 904-953-0746, punsky.kevin@mayo.edu

The study found the risk for stroke after either stenting or surgery (endarterectomy) was about 7 percent. The 10-year comparisons of restenosis (re-narrowing of the carotid artery) were low for both stenting and surgery – about 1 percent per year. Equal benefit was found for older and younger individuals, men and women, patients who had previously had a stroke, and those who had not.

“This very low rate shows these two procedures are safe and are also very durable in preventing stroke,” says CREST principal investigator Thomas G. Brott, M.D., a neurologist and the Eugene and Marcia Applebaum Professor of Neurosciences on Mayo Clinic’s campus in Florida. “Because Medicare-age patients with carotid narrowing are living longer, the durability of stenting and surgery will be reassuring to the patients and their families.”

Journalists: Sound bites with Dr. Brott are available in the downloads.

A carotid artery runs up each side of the neck. Plaque buildup can cause narrowing and hardening of the artery – a condition called atherosclerosis. This can reduce blood flow and cause clotting, which can result in a stroke.

Endarterectomy removes the narrowed segment of the artery surgically, while stenting uses a catheter to place a stent in the narrowed artery to widen it.

In 2010, phase one of CREST found stenting and surgery to be equally safe procedures, with fewer strokes among those who had surgery, and fewer heart attacks among those who received stents. Those results also were published in the New England Journal of Medicine.

“This second phase completes a story, and the results are very encouraging,” Dr. Brott says. “We have two safe procedures. We know now that they are very effective in the long run. Now the patient and the physician have the option to select surgery or stenting, based on that individual patient’s medical condition and preferences.”

Walter Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke, also noted that “the stroke rate in CREST was less than half of what was seen in similar studies from the late 1900s, which reinforces the benefits of modern medical control of vascular risk factors.”

Despite the results of CREST, the question of the best way to manage stroke risk has not been answered yet. Because of that, CREST-2 was launched in December 2014 to compare stenting and surgery to medical management. CREST-2, which is expected to end in 2022, is being funded by a $39.5 million grant from the National Institute of Neurological Disorders and Stroke.

“Carotid narrowing causes about 5 to 10 percent of all strokes in the U.S.,” Dr. Brott says. “Since there are about 800,000 strokes a year, we’re talking about 40,000 to 50,000 strokes a year. If we can find the best way to prevent those strokes, then we will have provided a service to those patients.”

CREST is funded by a grant (U01 NS038384-11) from the National Institute of Neurological Disorders and Stroke and the National Institutes of Health. Additional support comes from Abbott Vascular, including donations of Accunet and Acculink systems that were equivalent to approximately 15 percent of the total study cost, to CREST centers in Canada and the U.S. that were at U.S. Department of Veterans Affairs sites.

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About Mayo Clinic Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit mayoclinic.org or newsnetwork.mayoclinic.org.

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JACKSONVILLE, Flórida — Medicamentos são tão seguros e eficazes quanto a cirurgia ou implante de stent para prevenir um acidente vascular cerebral (AVC), causado pelo acúmulo de placas nas artérias carótidas? Isso é o que o neurologista da Clínica Mayo na Jacksonville, Flórida, Thomas G. Brott quer descobrir.

“Essa é uma pergunta fundamental”, diz Thomas Brott. “A qualidade dos medicamentos que temos hoje indicam que não é mais necessário realizar procedimentos invasivos em pacientes que não apresentam sinais de advertência de AVC. Mais de 100.000 cirurgias das carótidas e de implante de stents nas artérias carótidas são realizadas todos os anos nos Estados Unidos, em pacientes em risco — e isso pode não ser necessário”, ele afirma.

Para buscar uma resposta, o Instituto Nacional de Distúrbios Neurológicos e Acidente Vascular Cerebral (NINDS — National Institute of Neurological Disorders and Stroke) concedeu a Thomas Brott e seu colega James Meschia uma verba de US$ 39,5 milhões — uma das maiores já concedidas a pesquisadores da Clínica Mayo na Flórida. A verba vai financiar um estudo clínico de sete anos, que terá a participação de 2.480 pacientes em 120 instituições de saúde nos Estados Unidos, Canadá, Europa e Austrália. O estudo, que recebeu o nome de CREST-2, deve começar a inscrever pacientes no verão. A administração dos dados dos pacientes e as análises estatísticas serão feitas na Universidade do Alabama, em Birmingham, sob a direção de George Howard.

O neurologista Thomas Brott diz que é hora de reexaminar o controle médico dos riscos de AVC das artérias carótidas. Os últimos estudos da eficácia dos medicamentos na redução dos riscos de AVC nas carótidas foram iniciados nos anos 90, quando os pesquisadores compararam a eficácia de medicamentos com a da cirurgia também conhecida como endarterectomia da carótida (CEA — carotid endarterectomy). Nessa época, o implante de stent na artéria carótida (CAS — carotid artery stenting) ainda não havia sido desenvolvido e medicamentos como as estatinas, para baixar o nível de colesterol, estavam apenas chegando ao mercado.

“Pensamos, realmente, que precisamos descobrir qual é a melhor maneira de controlar o risco de AVC em nossos pacientes”, diz Thomas Brott. “Os dados que temos sobre controle médico já têm uma década, enquanto os medicamentos que estamos usando hoje são muito mais sofisticados”, ele explica.

O CREST-2 está sendo desenvolvido com base na infraestrutura criada para o estudo clínico da Endarterectomia de Revascularização da Carótida versus Implante de Stent (CREST – Carotid Revascularization Endarterectomy versus Stenting), que também foi liderado por Thomas Brott. As descobertas, anunciadas em maio de 2010, revelaram que a CEA e o CAS ofereciam resultados similares em termos de segurança e eficácia, em geral, se os pacientes tivessem ou não sintomas de doença das carótidas. Havia diferenças, no entanto, nas semanas que se seguiam aos procedimentos, observadas nos pacientes: os que se submeteram a implante de stent sofreram mais AVCs, enquanto os que se submeteram à cirurgia tiveram mais ataques cardíacos. A idade também faz diferença: as pessoas com menos de 70 anos se saíram melhor com stents, enquanto as com mais de 70 obtiveram melhor resultado com a cirurgia.

O CREST-2 vai consistir de dois estudos paralelos, mas separados, conduzidos em pacientes com estenose de carótida assintomática, com pelo menos 70% — ou mais — de obstrução em uma de suas artérias carótidas, mas que ainda não sofreram um AVC e não tiveram sinais de advertência de AVC.

Uma parte do CREST-2 vai comparar a combinação da CEA e controle médico com controle médico apenas. Outra parte vai estudar a combinação do CAS e controle médico com o controle médico apenas. Portanto, todos os pacientes participantes do estudo serão tratados com controle médico, que pode incluir medicamentos antiplaquetários para impedir coagulação — estatinas, entre outros agentes — e, quando apropriado, medicamentos para a controlar a hipertensão e o diabetes.

“Vamos nos assegurar, em todas as 120 instituições no CREST-2, que os pacientes recebam o controle médico da mais alta qualidade possível, junto com as melhores práticas em cirurgia e implante de stent”, diz Thomas Brott. “O CREST-2 deve nos oferecer a resposta definitiva sobre o que funcionar melhor e que pacientes devem ser tratados da doença da carótida”, afirma.

O estudo é financiado pela verba da NINDS 1U01NS080168-01A1.

Para mais informações sobre tratamento de AVC e doenças cardíacas na Clínica Mayo de Jacksonville, Flórida, contate o departamento de Serviços Internacionais pelo telefone 1-904-953-7000 ou envie email para intl.mcj@mayo.edu. Para mais informações em português, visite mayoclinic.org/portuguese/.

Veja um vídeo de Thomas Brott discutindo o estudo CREST no Canal da Clínica Mayo no YouTube.

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Informações sobre a Mayo Clinic
A Clínica Mayo comemora, em 2014, 150 anos de serviço à humanidade, como uma instituição sem fins lucrativos e líder mundial em tratamento médico, pesquisa e educação. Para mais informações, visite newsnetwork.mayoclinic.org/blogtag/portuguese-news-release/.

CONTACTO: Guta Bacelar, gbacelar@bellsouth.net

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The $39.5-million grant to fund stroke study is one of largest ever awarded to investigators at Mayo Clinic in Florida 

JACKSONVILLE, Fla. — Is medicine as safe and effective as surgery or stenting in preventing a stroke caused by the buildup of plaque in the carotid artery? Thomas G. Brott, M.D., a neurologist at Mayo Clinic in Florida, aims to find out.

“It’s a critical question. The quality medicines we have today may mean that it is not necessary to perform invasive procedures on patients who do not have warning signs of stroke,” Dr. Brott says. “More than 100,000 carotid surgeries and carotid artery stentings are performed each year in the United States on such patients at risk — and that may not be necessary.”

To find the answer, the National Institute of Neurological Disorders and Stroke (NINDS) has awarded Dr. Brott and his colleague, James Meschia, M.D., $39.5 million — one of the largest grants ever awarded to Mayo Clinic in Florida investigators. The grant funds a seven-year clinical trial that will enroll 2,480 patients in 120 centers in the United States, Canada, Europe and Australia. The study, known as CREST-2, is expected to begin enrolling patients this summer. Management of the patient data and the statistical analysis will be carried out at the University of Alabama at Birmingham under the direction of George Howard, Dr.PH.

Dr. Brott says it’s time for medical management of carotid artery stroke risk to be re-examined. The last studies of the effectiveness of medicine in reducing carotid stroke risk were initiated in the 1990s, when researchers looked at medicine versus surgery, also known as carotid endarterectomy (CEA). At that time, carotid artery stenting (CAS) hadn’t been developed, and drugs such as statins to lower cholesterol had just reached the market.

“We really think we need an answer as to the best management of stroke risk for our patients,” Dr. Brott says. “The data we have on medical management is decades old, but the drugs we are using today are much more sophisticated.”

CREST-2 is building upon the infrastructure developed in the CREST (Carotid Revascularization Endarterectomy versus Stenting) clinical trial, which Dr. Brott also led. The findings, announced in May 2010, found that CEA and CAS provided similar results in overall safety and effectiveness, whether or not patients had symptoms of carotid disease. There were differences, however, in the weeks following the procedures in patients — those who received a stent had more strokes, and patients treated surgically had more heart attacks. Age also made a difference — people younger than 70 did better with stents while those over 70 had better results with surgery.

CREST-2 will consist of two parallel but separate studies, conducted in patients with asymptomatic carotid disease who have at least 70 percent or higher blockage in one of their carotid arteries but who have not suffered a stroke and have not had warning signs.

One part of CREST-2 will compare a combination of CEA and medical management to medical management alone, and the other part will study CAS combined with medical management compared to medical management alone. Therefore, all enrolled patients will be treated with medical management, which can include antiplatelet drugs to prevent clotting — statins, among other agents — and when appropriate, drugs to manage hypertension and diabetes.

“We will ensure, at all of the 120 centers in CREST-2, that patients receive the highest-quality medical management possible, along with best practices in surgery and stenting,” Dr. Brott says. “CREST-2 should offer us the definitive answer to what works best in which patients to treat carotid disease.”

The study is funded by NINDS grant 1U01NS080168-01A1.

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About Mayo Clinic
Recognizing 150 years of serving humanity in 2014, Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit 150years.mayoclinic.org, MayoClinic.org or https://newsnetwork.mayoclinic.org/

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The award recognizes and rewards an individual who is making outstanding contributions to the advancement of cardiovascular science and who currently heads an outstanding cardiovascular clinical research laboratory. Dr. Brott is the first Mayo Clinic investigator to receive the prestigious prize, which has been awarded annually since 2005.

William Rupp, M.D., vice president at Mayo Clinic in Florida, says, “This award is well deserved. Dr. Brott is a pioneer in the field of stroke and cerebrovascular disease research, and his mission to find the best therapies possible for patients has certainly saved lives.”

Click here for news release.

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