Stroke patients experience superior outcomes with intra-arterial treatment vs. tPA
Comparative effectiveness results from MR CLEAN trial published in New England Journal of Medicine may redefine stroke treatment
2014-12-17
(Press-News.org) ALAMEDA, Calif. - December 17, 2014 - Penumbra, Inc., the market leader in intra-arterial stroke treatment, announced that an independent study published online today in the New England Journal of Medicine found that intra-arterial stroke treatment, including the company's clot extraction technology, was shown to be significantly more effective than medical management with tissue plasminogen activator (tPA), which is the current standard of care. The findings of this randomized, controlled comparative effectiveness trial of stroke treatment have the potential to change the standard of care and improve functional independence for the 15 million stroke patients worldwide who currently have few treatment options.
Intra-arterial treatment, also called endovascular or interventional treatment, involves working inside the artery to remove the clot. In the MR CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands) comparative effectiveness study, intra-arterial treatment improved the rate of good functional outcome by 71 percent over treatment with medical management with tPA alone. Of patients who received intra-arterial treatment, 32.6% achieved a clinically defined positive stroke outcome compared with 19.1% of those who received medical management. Intra-arterial treatment was beneficial for all ages (18+), including the elderly (80+) - a population for whom intervention was previously thought to be risky.(1) The trial began enrolling in 2010 and participating physicians used earlier generation intra-arterial technology. Currently available technology continues to improve upon the baseline set by MR CLEAN.
"Despite being the number one cause of long-term adult disability, stroke has been one of the most undertreated and devastating diseases in the world," said Albert J. Yoo, M.D., director of Acute Stroke Intervention in the Division of Interventional Neuroradiology/Endovascular Neurosurgery at Massachusetts General Hospital, assistant professor at Harvard Medical School and study author of MR CLEAN. "Now that intra-arterial treatment has been proven to provide significant benefits for stroke patients of all ages, we have a golden opportunity to dramatically improve the lives of stroke victims and, at the same time, help reduce costs in our healthcare system by returning patients to functional independence."
MR CLEAN also demonstrated:
Intra-arterial treatment was effective for patients with the most common and devastating form of stroke, LVO (large vessel occlusion), for which tPA is less effective.
Intra-arterial treatment is effective up to 6 hours after stroke onset vs. 3 to 4.5 hours for tPA.
Both treatments were safe, with no differences relating to hemorrhage or mortality.
"With the results of MR CLEAN, we have the needed evidence to support endovascular treatment in the fight against stroke, and the results are truly astounding," said Michael J. Alexander, MD, FACS, Director of the Neurovascular Center, Professor of Neurosurgery at Cedars-Sinai and past president of the Society of NeuroInterventional Surgery. "They show that endovascular treatment can benefit a broad population of patients - not just younger patients as previously thought but older patients as well if treated early."
"The MR CLEAN study results provide evidence to support intra-arterial treatment in the fight against stroke and have the potential to change the standard of care," said Adam Elsesser, chief executive officer, director and founder, Penumbra. "Penumbra is proud to have supported the MR CLEAN trial, and these important results will aid our efforts to improve access to intra-arterial treatment for the millions of stroke patients around the world."
Penumbra provided an unrestricted grant for the trial, and its devices were among those included in the protocol. Companies providing grants had no influence over the trial's design or execution. Penumbra's newest intra-arterial treatment, which was not available at the time MR CLEAN was conducted, is the ACE™, a next generation clot extraction system that uses aspiration alone to engage and remove blood clots causing an acute ischemic stroke. Results with the Penumbra ACE system continue to improve upon the baseline set by MR CLEAN.
INFORMATION:
About the MR CLEAN Study
MR CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands) was a prospective, randomized clinical trial comparing intra-arterial treatment with medical management using tissue plasminogen activator (tPA). The study enrolled 500 patients, and unlike previous studies, MR CLEAN specified that large vessel occlusion (LVO) had to be confirmed by CT angiography (CTA). Once confirmed, all patients were first administered tPA if eligible; 233 were then assigned to the intra-arterial treatment arm and 267 to the control arm. All stroke centers in the Netherlands participated in the study, and the intervention and control groups were well balanced. Intra-arterial devices were used at the discretion of the treating physician to include stent retrievers, direct aspiration or combination therapy. Primary endpoint was measurement of blinded modified Rankin Scale (mRS) scores at 90 days. The modified Rankin Score (mRS) is the most widely used clinical outcome measure for stroke clinical trials; an mRS score of 2 or less is considered to be the threshold for positive stroke outcome.
About Penumbra
Penumbra, Inc. is an independent medical device company committed to delivering clinically beneficial products that help patients suffering from stroke and other vascular diseases. Penumbra's global headquarters is located in Alameda, California with sales operations around the world.
1. Berkhemer OA, Fransen PSS, Beumer D, et al. A randomized trial of intra-arterial treatment for acute ischemic stroke. NEJM online publication. December 17
[Attachments] See images for this press release:
ELSE PRESS RELEASES FROM THIS DATE:
2014-12-17
New Haven, Conn. - A Yale University lab has crafted the first synthetic molecules that have both the targeting and response functions of antibodies.
The new molecules -- synthetic antibody mimics (SyAMs) -- attach themselves simultaneously to disease cells and disease-fighting cells. The result is a highly targeted immune response, similar to the action of natural human antibodies.
"Unlike antibodies, however, our molecules are synthetic organic compounds that are approximately one-twentieth the size of antibodies," said David A. Spiegel, a professor of chemistry at ...
2014-12-17
Promising treatments known as biologics are on the market and under development for many serious illnesses such as cancer, but some of them come with high risks, even lethal ones. Now scientists have produced a novel class of molecules that could be as effective but without the dangerous side effects. They report their work on these compounds, which they tested on prostate cancer cells, in ACS' Journal of the American Chemical Society.
David A. Spiegel and colleagues explain that biologics are protein-based therapies that have revolutionized cancer treatment over the ...
2014-12-17
It takes some cooking, but turning farm waste into biofuels is now possible and makes economic sense, according to preliminary research from the University of Guelph.
Guelph researchers are studying how to make biofuels from farm waste, especially "wet" waste that is typically difficult to use. They have developed a fairly simple procedure to transport waste and produce energy from it.
Scientists have struggled to find uses for wet and green waste, including corn husks, tomato vines and manure. Dry farm waste, such as wood chips or sawdust, is easier to use for generating ...
2014-12-17
Many consumers seek out shampoos, soaps and cosmetics that are labeled "hypoallergenic" or "dermatologist tested," words that imply the products are safe to use. But recent research gives shoppers reason to question what those labels really mean. Now some scientists and consumer advocates are calling for change, according to an article in Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society.
Britt E. Erickson, a senior editor at C&EN, notes that the definitions of the terms "hypoallergenic" and "dermatologist tested/recommended" ...
2014-12-17
MANHATTAN, KANSAS -- It may be beneficial for employers to not only encourage office Christmas parties but also celebrate holidays and festivals from a variety of religions, according to a Kansas State University researcher.
Sooyeol Kim, doctoral student in psychological sciences, was involved in a collaborative study that found that employees who openly discuss their religious beliefs at work are often happier and have higher job satisfaction than those employees who do not.
"For many people, religion is the core of their lives," Kim said. "Being able to express important ...
2014-12-17
SAN FRANCISCO--A new study is helping to answer a longstanding question that has recently moved to the forefront of earth science: Did our planet make its own water through geologic processes, or did water come to us via icy comets from the far reaches of the solar system?
The answer is likely "both," according to researchers at The Ohio State University-- and the same amount of water that currently fills the Pacific Ocean could be buried deep inside the planet right now.
At the American Geophysical Union (AGU) meeting on Wednesday, Dec. 17, they report the discovery ...
2014-12-17
SAN FRANCISCO--Of the many weather-related factors that contribute to harmful algal blooms (HABs) in Lake Erie, a new study has identified one as most important: the wind.
Over a 10-year period in Lake Erie, wind speed contributed more consistently to HABs than sunshine or even precipitation, researchers at The Ohio State University and their colleagues found.
The ongoing study is unusual, in that researchers are building the first detailed analyses of how the various environmental factors influence each other--in the context of satellite studies of Lake Erie.
They ...
2014-12-17
Singapore, Date - A more effective treatment for tuberculosis (TB) could soon be available as scientists have discovered that Metformin (MET), a drug for treating diabetes, can also be used to boost the efficacy of TB medication without inducing drug resistance.
This discovery was made by a team of international scientists led by the Singapore Immunology Network (SIgN), a research institute under the Agency for Science, Technology and Research (A*STAR), Singapore.
TB is an air-borne infectious disease caused by a bacterium called Mycobacterium tuberculosis (Mtb), which ...
2014-12-17
The extinction of the dinosaurs 66 million years ago is thought to have paved the way for mammals to dominate, but a new study shows that many mammals died off alongside the dinosaurs.
Metatherian mammals--the extinct relatives of living marsupials ("mammals with pouches", such as opossums) thrived in the shadow of the dinosaurs during the Cretaceous period. The new study, by an international team of experts on mammal evolution and mass extinctions, shows that these once-abundant mammals nearly followed the dinosaurs into oblivion.
When a 10-km-wide asteroid struck ...
2014-12-17
The Center for RNA Research at the Institute for Basic Science (IBS) has succeeded in revealing, for the first time, the mechanism of how miRNAs, which control gene expression, are regulated in the early embryonic stage.
The IBS researchers have verified that maternally inherited miRNAs are highly adenylated at their ends in mature oocytes and early embryos. This maternal miRNA adenylation is extensively conserved in fly, sea urchin and mouse. The researchers have also identified that the enzyme called 'Wispy' is required to catalyze miRNA adenylation and to reduce miRNA ...
LAST 30 PRESS RELEASES:
[Press-News.org] Stroke patients experience superior outcomes with intra-arterial treatment vs. tPA
Comparative effectiveness results from MR CLEAN trial published in New England Journal of Medicine may redefine stroke treatment
