New AHA/ASA Guidelines for Acute Stroke Treatment

The American Heart Association/American Stroke Association has released new guidelines on the early management of acute ischemic stroke.

The document is published online January 31 and will appear in the March issue of Stroke. The American Academy of Neurology "affirms the value of this guideline as an educational tool for neurologists," and it is further endorsed by the American Association of Neurological Surgeons and the Congress of Neurological Surgeons.

"There's no revolutionary change in these guidelines for us considering what we published back in 2007," Edward Jauch, MD, lead author of the guidelines and director of the Division of Emergency Medicine at the Medical University of South Carolina, Charleston, told Medscape Medical News.

"It's more of an evolutionary change, and it solidifies our understanding of several factors," he said.

Stroke Systems

Primary among these is the importance of stroke systems of care, modeled on a page taken from the treatment of myocardial infarction by cardiologists.

"We've taken a similar approach to stroke systems of care, by first off, defining stroke capabilities now at 4 levels of hospitals," Dr. Jauch said. These include comprehensive stroke centers, now eligible for Joint Commission certification, that offer 24/7 specialized treatment for all stroke types; primary stroke centers that also provide around-the-clock care, mainly for ischemic stroke, a ranking that has been established for about 6 years now; acute stroke-ready hospitals, which can evaluate and treat most strokes but without specialized capabilities; and community hospitals.

The establishment of these acute stroke-ready hospitals is based on current experience with telemedicine, Dr. Jauch said, "and that actually has had a large impact in the last decade or less, where hospitals that would never have a neurologist available, or have one only on a part-time basis now has access to stroke expertise using the telemedicine system. With the experience we've garnered in the last 5 or 10 years, we know these systems a) can be put in place, and b) can deliver a quality of care that is comparable to if the patient had been treated in a primary stroke center," at least for the provision of thrombolysis.

Some hospitals with telemedicine will be able to keep the patient in their own stroke unit, whereas others will not, he added, "but at least they have elevated their acute assessment capabilities for thrombolysis candidates by having a telemedicine collaboration with typically a comprehensive stroke center."

The guidelines recommend use of teleradiology systems to support decision-making about whether to use fibrinolysis.

For patients with hemorrhagic stroke, data now support use of neurosurgical procedures, such as decompressive surgery to address malignant edema of the cerebral hemisphere. "We know that that's a decision that requires a neurosurgeon, so the goal is, if you think this is necessary, this is where your systems of care come in," he said. "We've increased the class and level of evidence for those procedures."

Shorter Door-to-Needle, Longer Window

Another addition to the previous 2007 guideline is incorporation of the 2009 Scientific Advisory that recommended the use of tissue plasminogen activator (t-PA) in selected patients presenting within 3 to 4.5 hours of symptom onset, largely on the basis of the findings from the  third European Cooperative Acute Stroke Study (ECASS 3) trial.

"That's the first time that's been included in the guideline as a recommendation," Dr. Jauch noted. "That's despite the fact that the Food and Drug Administration (FDA) has declined to extend the label. So it's an off-label use of t-PA from 3 to 4.5 hours, but the authors feel it still has merit to consider in the appropriately selected patients.

"That's an important one, because you always get a little concerned when the FDA declines to extend the label for various reasons, but we were able to go back and talk to the parties involved, and find out a little bit more about how the decision was made, and after that discussion we feel comfortable with our recommendation."

Another new recommendation notes that in patients eligible for thrombolysis, door-to-needle times should be within 60 minutes of hospital arrival (Class I, level of evidence A).

Intraarterial Thrombolysis

Several new stent retriever devices have now received FDA approval, including the Solitaire FR and Trevo devices, in addition to Merci and PenumbraSystem coil retrievers. However, available data suggest that the stent retrievers achieve recanalization more rapidly, at least to the Merci, and are therefore preferred (Class I, level of evidence A). Data comparing these retrievers with the Penumbra system are not yet available.

"We always believe that time is brain and faster is better, so it's one of the things we need to continue to look at," Dr. Jauch said. "The big question is, regardless of which device you use, is there a benefit to going to the cath lab? So we'll have data presented next week from the International Stroke Conference looking at mechanical embolectomy with or without intravenous tPA, and we'll get a lot more guidance on when and in whom we use these devices."

"They're still worth considering, but we think they need additional evaluation to really look at their clinical efficacy when we compare it to say, standard therapy like IV t-PA," he said.

High on the list of these is Randomized Trial of Neuroimaging Selection for Mechanical Embolectomy versus Standard Care for Acute Ischemic Stroke (MR RESCUE), which is examining not only mechanical embolectomy but also use of perfusion-based imaging to select patients.

Another, the long-anticipated Interventional Management of Stroke III (IMS-III) trial, will be presented by principal investigator Joseph P. Broderick, MD, from the University of Cincinnati, Ohio, at a session dedicated just to this trial.

IMS III was a phase 3, randomized, open-label trial assessing whether a combined intravenous and intraarterial approach to stroke treatment was superior to intravenous tPA alone. As reported previously by Medscape Medical News, the trial was halted in April 2012 when a preplanned interim analysis showed "a low likelihood of demonstrating the pre-specified clinically significant difference in benefit between treatment arms of the study," according to a statement from the National Institute of Neurological Disorders and Stroke at that time.

The Data and Safety Monitoring Board's decision was based on the primary outcome of the trial, the Modified Rankin Score at 3 months, "meeting the threshold for futility," the statement added. "While enrollment was stopped because of futility, no serious safety concerns were identified."

In the meantime, the guideline authors did "hedge" their conclusion, pointing out these data are on the cusp of being presented and their recommendations may need revision in light of any new information, he noted. They support use of these devices in patients in whom intravenous tPA has failed, although more data are needed on outcomes with this approach. Recent data indicate that clot size and location are important predictors of patients who may or may not benefit from rescue therapy, Dr. Jauch said.

They continue to support use of intraarterial tPA, although they note the best dose is not yet known.

Other data are expected to be presented this spring, Dr. Jauch added, including SYNTHESIS-EXP(Intra-arterial versus Systemic Thrombolysis for Acute Ischemic Stroke) and the ALIAS (Albumin in Acute Ischemic Stroke) and FAST-MAG (Field Administration of Stroke Therapy-Magnesium) neuroprotective studies.

"So it's going to be an exciting and maybe humbling spring when all these trials that are either finished and/or were stopped are reported, and we'll be able to take a step back and say now that we have this additional experience, what's the next step, where do we go from here to further evaluate stroke therapies and most importantly, how do you tailor the therapies on a more individual basis, rather than trying to find a one size that fits all."

The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association's science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding.

Stroke. Published online January 31, 2013. Abstract

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Cite this: New AHA/ASA Guidelines for Acute Stroke Treatment - Medscape - Jan 31, 2013.