Tag Archives: stroke

Prevent Atherothrombotic Events? It’s Complicated

When researchers reported earlier this week at the American College of Cardiology’s annual meeting results from the TRA 2P-TIMI 50 trial, which tested a novel anticoagulant drug, vorapaxar, for preventing cardiovascular death, myocardial infarction (MI), and stroke in stable patients with cardiovascular disease, the results showed a questionable balance between benefit and bleeding risk that only looked good if you squinted and confined the analysis to patients with just a history of MI, no history of stroke, a body weight of at least 60 kg, and, ideally, those who were younger than 75 years old. Even within this pared-down universe, experts differed on whether vorapaxar had an unequivocal net benefit after taking into account the bleeding risk it caused.

But if vorapaxar someday gets FDA approval and appears on the U.S. market, physicians will face the tricky calculus of how to use it compared with the other new, potent antithrombotic drugs.

blood clot/courtesy Janice Carr; Public Health Image Library

Looking at vorapaxar’s performance in patients with stable cardiovascular disease, it was hard not to recall last November’s report on the ATLAS ACS 2-TIMI 51 trial, which tested adding a 2.5 mg b.i.d. dosage of another new anticoagulant drug, rivaroxaban, in acute coronary syndrome (ACS) patients also treated with aspirin and clopidogrel. In ATLAS, adding this small dose of rivaroxaban led to benefit and a bleeding risk that was strikingly similar to the pattern seen with vorapaxar in TRA 2P.  Rivaroxaban on top of aspirin and clopidogrel produced an absolute, 1.6% cut in the combined rate of cardiovascular death, MI, or stroke while boosting the rate of major bleeds by an absolute 1.2%, and the rate of intracranial bleeds by 0.2%. The new vorapaxar results showed that in the best-case subgroup, adding the drug to aspirin and clopidogrel cut cardiovascular death, MI, or stroke by an absolute 1.9%, while boosting major bleeds by 1.0% and intracranial hemorrhage by 0.2%.

A big difference in the two analyses was that the benefits and risk seen with 2.5 mg rivaroxaban was in the entire study population of 5,100 patients, with no need to resort to subgroup analyses. The vorapaxar result was in about 9,500 patients, roughly 70% of all patients enrolled in the trial. Another big difference was the major impact of rivaroxaban was on cutting cardiovascular deaths. Vorapaxar’s main effect was to lower nonfatal MIs. It cut cardiovascular deaths too, but not as well as low-dose rivaroxaban.

Many experts whom I spoke with at the meeting seemed confident that low-dose rivaroxaban is on track for FDA approval later this year for treating ACS patients. Whether Merck, the company developing vorapaxar, will seek FDA approval for its drug in stable patients based on the TRA 2P data remains to be seen.

But while rivaroxaban won’t receive labeling for treating non-ACS patients, all that separates an ACS patient and a patient who is stable but with a history of prior MI is time; in fact, just a few weeks or months. The point at which an acute ACS patient becomes a stable, post-MI patient is pretty murky. Would anyone consider treating a stable, post-ACS patient with low-dose rivaroxaban? The labeling probably won’t cover it, but will the temptation be there? And the what-ifs don’t stop there.

Both the low-dose rivaroxaban study and the vorapaxar study used aspirin and clopidogrel as standard, background treatment. But U.S. physicians are increasingly switching from clopidogrel to the newer, more potent antiplatelet drugs already on the market, prasugrel and ticagrelor, several experts told me at ACC. Putting a patient on prasugrel or ticagrelor plus aspirin will likely preclude any thought of also adding rivaroxaban, not to mention vorapaxar. These combinations have not been tested, and given the bleeding risks that these drugs pose individually, the idea of using them in combination is downright scary.

After several years when clopidogrel plus aspirin reigned alone as the top treatment for preventing atherothrombotic events, the last few years brought a flurry of new agents. How these drugs compare and relate to each other, and how they are optimally used alone or in combination, will take several more years to sort out.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Revolutionizing Ischemic Brain Management, at a Stroke

When Dr. Jeffrey Saver announced last week at the International Stroke Conference that treatment of acute, ischemic stroke patients with the Solitaire retrievable stent produced a 61% rate of complete recanalization, he predicted that this landmark result would quickly propel acute stroke management into a new era.

It sounds a bit audacious for the results of a study with 113 randomized patients to change the face of U.S. management of acute, ischemic stroke patients, but Dr. Saver laid out a compelling scenario at the meeting. In essence, it’s the right result for the right device at the right time.

MRI head scan/courtesy Wikimedia Commons/Ranveig Thattai/creative commons license

Acute stroke care in America is already poised at an important threshold. Last week, The Joint Commission, the U.S. organization responsible for accrediting health-care institutions, announced their newly crafted criteria for credentialing Comprehensive Stroke Centers. By next year, Dr. Saver predicted, 100-200 such centers will have received this designation into the highest tier of acute stroke management. He expects all these locations to treat patients with the Solitaire stent, as well as a few others. “At least 250” U.S. sites should be using it within the next couple of years, he told me. In addition, an emergency-medicine culture already exists to ambulance acute stroke patients to one of the 1,000 Primary Stroke Centers that now exist in America, use imaging to identify the ones who qualify for intravenous lytic therapy with tissue plasminogen activator (t-PA), start administering the drug, and then transfer them to a center that can apply more advanced care, a strategy know as “drip and ship.”

Having the Solitaire device takes this approach a step further, making it “drip, ship, and grip,” he told me, with grip being the step when the thrombus causing the stroke is engaged and removed.

“We stand poised at a new era, our first experience with highly effective cerebral revascularization,” he said at the meeting last week. “The open secret in our field is that t-PA or the devices now available deliver treatment that fails most of the time.” Intravenous t-PA by itself produces full recanalization in about 5% of patients, while existing devices up this to 25%; for Solitaire the rate was 61% in the new randomized study, and the rate of full or partial recanalization was 83%.

This new level of success with Solitaire will make a big difference in how widely the treatment gets used, he told me.

Dr. Jeffrey Saver MITCHEL ZOLER/Zoler/Elsevier Global Medical News

“I think motivations [to use endovascular interventions] will shift with a more reliable device. That will drive wider uptake.” He called it a “paradigm shift” and a “game changer.”

Rapid application of effective endovascular therapy “was the vision of acute stroke care that was a hazy dream when I first became a stroke neurologist 20 years ago,” Dr. Saver said. “I think that in the next few months and years it will become the reality.”

—Mitchel Zoler (on Twitter @mitchelzoler)

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Do Trauma Patients Need An Aspirin?

Acute traumatic injury has been shown to produce a prothrombotic state that predisposes trauma patients to an increased risk of venous thromboembolic events. But are these patients also at increased risk for stroke?

Researchers at the University of Louisville report that trauma patients were 1.6 times more likely to develop a cerebrovascular accident (CVA) after admission than medical and surgical controls matched for known CVA risk factors such as age, hypertension, diabetes, atrial fibrillation, and tobacco use.

On logistic regression, trauma was the only significant risk factor for CVA between the two groups, Dr. Jason W. Smith reported at the recent meeting of the Eastern Association for the Surgery of Trauma.

By Patrice Wendling/Elsevier Global Medical News

Dr. Smith called for more studies concerning the etiology and management of post-traumatic hypercoagulability and suggested that “CVA prophylaxis may be warranted in select trauma patients.”

The analysis identified 64 strokes after admission among 7,633 trauma admissions from 2008-2010, for an overall CVA rate of 0.8%. Out of this group, 23 strokes were found to be related to TBI and blunt cervical vascular injury, leaving 41 patients with non-injury related CVA in the analysis. The medical/surgical controls included 14,121 patients obtained from the university’s hospital database over the same time period.

When compared with a second control group of 120 trauma patients matched for Injury Severity Score and mechanism of action, the 41 trauma-related CVA patients presented with significantly more stroke risk factors, including older age, pre-existing hypertension, diabetes, and tobacco use.

Their chance of placement in an extended care facility also skyrocketed from 28% to 81%, while mortality rates more than tripled from 7% in controls to 22% in the trauma-related CVA patients, Dr. Smith and his co-authors reported.

The one bright spot was that on follow-up in the medical/surgical analysis, trauma patients had higher six-month post-CVA functional assessment compared with the controls.

–Patrice Wendling

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Stroke Hospitalizations Increase in Young Adults

I bet a lot of people jumped to conclusions when the U.S. Centers for Disease Control and Prevention (CDC) announced that hospitalizations of some young people for acute ischemic stroke increased by as much as 53% between 1994-1995 and 2006-2007. I know that the first thought crossing my mind was, “Blame the obesity epidemic.”

Photo courtesy flickr user wsilver.

But it’s not that simple, and the story illustrates the many nuances of interpreting medical and epidemiologic studies. For one thing, note that the CDC studied hospitalization rates, not stroke rates, so the study isn’t necessarily saying that young people are having more strokes. You can’t make that assumption. Other factors may have led to more hospitalizations.

Also, hospitalizations for stroke increased or decreased in different age groups, Dr. Mary G. George of the CDC and her associates reported at the International Stroke Conference. That led some physicians at the meeting to pat themselves on the back, believing that their efforts helped decrease stroke hospitalizations in adults aged 45-64 or 65 and older, while others scratched their heads over increased stroke hospitalizations in three younger age groups: 5-14 years; 15-34 years, and 35-44 years. The youngest age group diverged by sex, with a decrease in stroke hospitalizations in females and no significant change in males aged 0-4 years.

As alarming as it sounds to hear that more teenagers and young adults are being hospitalized for stroke, it’s important to keep in mind that these are still rare. For example, the biggest increase in stroke hospitalizations — a 53% jump — was seen in young men aged 15-34 years. But in absolute terms, only 15 of every 10,000 men in that age group who were hospitalized in 2006-2007 had acute ischemic strokes.

I certainly don’t mean to dismiss concerns about the obesity epidemic and other risk factors for stroke such as hypertension and diabetes, or about increased stroke hospitalizations in some age groups. But Dr. Lee H. Schwamm, director of telestroke and acute stroke services at Massachusetts General Hospital, Boston, explained how these are unlikely to be the cause of increased stroke hospitalizations in young people. Listen to this podcast with Dr. Schwamm, created from interviews released by the American Heart Association and American Stroke, which sponsored the meeting.

Whatever factors may be responsible for increased stroke hospitalizations in young people, we’ve still got to decrease the traditional risk factors for stroke (obesity, hypertension, diabetes), he emphasized, “otherwise we will have a wave of cardiovascular disease and stroke in the next 20-30 years.”

— Sherry Boschert (@sherryboschert)

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Brain Imaging May Expand Stroke Treatment

Using MRI to look at the brains of people who’ve had a stroke but who can’t tell when the stroke began might help identify those who could safely be treated. Approximately 25% of ischemic strokes occur in people who don’t know, or are unable to communicate, when their stroke began. That usually makes them ineligible for thrombolytic therapy, which must be given within 4.5 hours of the onset of stroke symptoms, according to treatment guidelines.

A preliminary study of 430 patients with unclear-onset stroke used MRI to select 19 patients who were thought to be within that treatment window, Dr. Dong-Wha Kang of the University of Usan, Seoul, South Korea reported at the International Stroke Conference. Treating those 19 resulted in a good clinical outcome in 37 (45%), which Dr. Kang said is encouraging enough to justify further studies of this approach.

He showed three examples of MRIs to illustrate how they selected patients for treatment. The first image shows no mismatch between brain lesions viewed on diffusion-weighted imaging (DWI) or fluid-attenuated inversion-recovery (FLAIR) MRI. This patient was considered a poor candidate for treatment and was not enrolled in the study.

The second image shows a partial FLAIR change within the DWI lesion and a perfusion-diffusion mismatch. This patient was eligible for treatment.

All images courtesy Dr. Dong-Wha Kang.

The third image shows a large perfusion-diffusion mismatch and no FLAIR changes within the DWI lesion, making this a good candidate for treatment in the study.

Everyone agrees the study wasn’t strong enough to change clinical practice, and reasons for wanting further studies differed. Some were encouraged and want more studies to see if this approach pans out. Others were skeptical and want more studies to prove that there’s really something of value here besides pretty images.

Hear Dr. Mark Alberts, professor of neurology and director of the stroke program at Northwestern University, commenting on the study in a  minute-and-a-half podcast  provided by the American Heart Association and the American Stroke Association (sponsors of the conference).

And learn more from my full story and video.

— Sherry Boschert (@sherryboschert on Twitter)

 

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Does ‘Stroke Center’ Label Improve Care?

I heard an interesting debate at the International Stroke Conference about whether or not having a “Stroke Center” designation improves outcomes for patients with stroke. What made it even more interesting is that the debater arguing against this idea is director of a certified Stroke Center.

The Joint Commission, in collaboration with the American Heart Association and the America Stroke Association, developed certification criteria and started designating qualified medical centers as Primary Stroke Centers beginning in December 2003. The idea was to recognize centers that could provide superior care for people with acute ischemic stroke and motivate other centers to reach for this level of excellence.

There are now more than 800 certified Primary Stroke Centers in 49 states. Here’s a list, and more info on Stroke Centers. Have patient outcomes after stroke improved because of all this?

Dr. Mark J. Alberts Image courtesy Northwestern University

Dr. Mark J. Alberts, director of the stroke program at Northwestern University, Chicago, cited lots of evidence over many years showing higher rates of using clot-busting drugs, lower death rates, and less need for institutionalization when patients were treated in stroke units compared with other hospital care. Impressive.

Dr. S. Claiborne Johnston Image by Sherry Boschert

 

Most of that data, however, came from studies conducted before The Joint Commission started handing out the Stroke Center designation, noted Dr. S. Claiborne Johnston, director of the stroke service at the University of California, San Francisco. He agreed that care is better at Primary Stroke Centers, but argued that these were the centers that already were excelling at stroke care and working hard to improve stroke care, and so they applied for and earned the Primary Stroke Center labels. There’s no evidence that the label itself improved outcomes at those centers.

I suppose Dr. Johnston won the debate on a verbal technicality. But he graciously posed a different question that probably everyone could agree upon: Does society benefit from Stroke Center certifications? It sure seems so. Because of Stroke Center certification, emergency medical services teams steer ambulances toward Stroke Centers and bypass non-certified hospitals when they have a patient with stroke on board. By providing a framework for regionalization of care, the Stroke Center designation helps get patients to hospitals that provide better stroke care, improving outcomes on a society-wide level.

–Sherry Boschert

(Follow me on Twitter @sherryboschert)

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Which Would You Rather Risk: Stroke or MI?

It sounds like the ultimate trick question, where the correct answer is, of course, C: none of the above.

image courtesy Flickr user chase baltz

But the choice between stroke, myocardial infarction (MI), or another cardiovascular end point, such as need for revascularization, is something now faced by patients confronted by at least a couple of somewhat different clinical situations where treatment of their vascular disease could be done by either endovascular stenting or open surgery. (Sometimes the third option is medical management and no surgery, but these are cases too advanced for medicine alone to work).

One of these situations is severe carotid artery stenosis (especially when the patient already had a stroke or transient ischemic attack).  Last year, results from CREST, the largest randomized study to compare the two main treatment options for these patients, cartoid artery stenting or open surgery by endarterectomy, showed that overall the two treatments led to similar 4-year outcomes based on the cumulative rate of death, stroke, or MI. But more detailed results, hinted at in last year’s report and then expanded on earlier this month at the International Stroke Conference, showed that the choice is a lot more nuanced, and in many ways boils down to what a patient would rather risk, having a MI or stroke. Carotid-artery stenting produced more strokes, especially in women and older patients (65 or older). Carotid endarterectomy produced more MIs, especially in men.

The gut reaction has generally been to regard strokes as a worse outcome, but now other new data from CREST, also reported at the stroke conference, prove it’s true. Dr. Joshua M. Stolker reported on the health-status outcomes from CREST. In part, this showed that CREST patients who had a stroke following their intervention had significant decrements in seven of eight quality-of-life measures on the Short Form-36, compared to a decrement in just one SF-36 measure among the patients who had a MI. Patients with major strokes had decrements in all eight subdomains, but even patients with minor strokes had significant decrements in three or four subdomains, so even a minor stroke was quantitatively worse for patients, on average, than a MI.

The analysis “confirmed what a lot of us already suspected,” Dr. Stolker said when he gave his report.

The stroke or MI choice seen in CREST was reminiscent of the results seen in 2009 from the SYNTAX trial, the most recent study to compared coronary artery bypass surgery with coronary stenting. Interesting, in SYNTAX the adverse event profile was somewhat flipped. In this case it was the CABG patients who underwent open surgery who had a significantly increased rate of stroke during follow-up compared with stented patients. The excess risk faced by patients treated with the endovascular intervention was an increased rate of a need for revascularization therapy down the road.

As far as I know, no follow-up study examined the health impact of the strokes that occurred in SYNTAX and the impact of revascularization, but it’s hard to imagine that the result would be different from what was found in CREST. A stroke is a stroke, and a nasty outcome for patients regardless of their medical history.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Stents-on-Sticks Score for Acute Stroke

Late yesterday afternoon, I heard about the future of acute stroke treatment: retrieving the culprit blood clot with a removable stent, also known as stent retrievers, stentrievers, and stent-on-a-stick.

stent-on-a-stick; photo by Mitchel Zoler from an image shown by Dr. Aleu

Dr. Aitziber Aleu, an interventional neurologist from Hospital Germans Trias i Pujol near Barcelona, presented the combined experience from three Barcelona-area hospitals using two different brands of stentrievers to treat 89 acute stroke patients during March 2008-December 2010. This was the largest series of stroke patients yet reported who underwent this type of treatment, and a rapt, electrified audience of stroke interventionalists who heard her speak at the International Stroke Conference in Los Angeles kept her on the podium after her talk was over, peppering her with their questions.

Her most notable findings: Using an average of 1.4 passes per patient to remove the clot from a cerebral artery the stentrievers produced good blood flow, TIMI 2 or 3,  in 91% of patient, with hemorrhage occurring in 11% of patients. At 90 days after treatment, 47% had a good outcome, with a modified Rankin scale score of 2 or less, and mortality was 20%. All those numbers were either as good or better than what is routinely achieved with the main clot-removal devices now used, the MERCI clot-spearing device and the Penumbra clot-suction machine. The recannalization rate is better, the procedure time is shorter, the hemorrhage rate about the same.

“The advantage is the stents are very easy to use and they are faster, recannalizing in fewer passes,” Dr. Aleu told me. She said that the self-expanding stent quickly and effectively entangles the clot within its struts so that the clot leaves when the stent is removed.

“Stent retrievers are the next generation of tools,” said the session’s co-chair, Dr. Adnan H. Siddiqui, director of stroke and neurosurgical research at the University of Buffalo. Clot retrieval with an average of 1.4 passes “is incredible,” he said. The approved devices usually require four or five passes. He said that has used one of the two devices now in testing, the Solitaire, on about a dozen patients as part of the 200-patient, U.S.-based  SWIFT trial, which is comparing this stent retriever against the MERCI.  (The other retrievable stent used in Barcelona is the Trevo.) The stent retriever is “more maneuverable and more deliverable” than what’s out there, he told me. And he was thrilled that 47% of patients had good recoveries, with modified Rankin scores of 2 or less.

“The best results now are 40%-45% of patients” reaching this level of stroke recovery. “Fifty percent is the next target,” he said, a goal he hopes will be reached in the SWIFT trial and in other stent retriever studies now underway.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Carotid Artery Stenosis: Winner Takes All?

Photo courtesy of Flickr user Charles Williams (CC)

Let’s admit it.  Those debate sessions at most medical meetings are pretty contrived.  Debating the BEST therapeutic option for carotid stenoses in asymptomatic patients–as three vascular experts did at the annual meeting of the Society for Vascular Surgery–is not only contrived but also potentially never ending as technique and technology continue to improve.

While I was sitting there, listening to this debate again–medical management vs. carotid endarterectomy (CEA) vs. carotid artery stenting (CAS)–I was very pleased to hear that there was someone else, who also thought that debating the best approach is, well, not the best approach to these patients.

“Why can there be only one winner?  In fact, why can’t there be more than one acceptable therapeutic approach,” asked Dr. Kim Hodgson, who is the chair of vascular surgery at Southern Illinois University, Springfield.  Dr. Hodgson had been tasked with making the case for CAS.

The debate illustrated that, for asymptomatic patients with carotid stenoses, there is good evidence for medical management and CEA, and even for CAS in certain patients.

Dr. Hodgson related that his plane to Boston had been late because of mechanical problems.  This got him thinking.  “As mechanics, there’s only one right way that they can repair this plane … I came to realize that there’s a difference between us and mechanics.  I think of us more as tailors.  I think we need to recognize that there could be more than one acceptable therapeutic approach.  We have to tailor this to our patients.”

In part, the controversy over CEA vs. CAS has been driven by competition between specialties–vascular surgeons and cardiac surgeons/cardiologists–and a “dysfunctional winner-takes-all mentality,” he said. In industry, this winner-takes-all mentality takes the form of a rush to be the first to market, which “leads to poorly designed and anemic scientific trials.”  In this scenario, the biggest losers may be patients, who are at the mercy of the currently blowing winds of trial data.

—Kerri Wachter, @knwachter on Twitter

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Sex Differences Poorly Understood

From a workshop on sex differences and their implications for translational neuroscience research, sponsored by the Institute of Medicine.

Sex, sex, sex. That’s all they talked about at this day-long workshop in San Francisco, and it was more interesting than you might think. (Or maybe not, depending on what you’re expecting…)

Researchers from basic scientists to clinicians decried how too few studies look at sex — as in the differences between males and females (not sexuality or sex behaviors). The terminology is important, and they clarified up front that the topic of the day was sex, not gender.

Surprisingly, that clarification prompted one of the speakers to change her terminology on the fly. (She had been planning to refer to sex differences as gender differences.) That, as much as anything I heard that day, showed me how far the scientific and medical communities have to go to get the topic of sex differences front and center. In fact, the Institute of Medicine convened the workshop to assess progress since it called for more research on sex differences in its 2001 report, “Exploring the Biological Contributions to Human Health: Does Sex Matter?” (National Academies Press).

Why is this important? Although the impetus for better understanding of sex differences largely has come from proponents of improving the health of women (who long have been under-represented as research subjects), the lack of attention to biological differences between the sexes hurts both men and women.

Just one example: After more than 100 rodent studies showed that dextromethorphan (a common ingredient in cough syrups) potentiated the analgesic effects of morphine, a drug company launched a clinical trial in humans on treating chronic pain with the drug combination. It bombed. The company abandoned the formulation.

But a review of rodent studies in general found that 87% used only male rodents, didn’t specify the rodent sex, or didn’t assess sex differences in the few studies that included female mice or rats. Jeffrey S. Mogil, Ph.D. of McGill University’s Centre for Research on Pain, Montreal and his associates discovered that the potentiating effects of dextromethorphan on morphine work only in male rodents. Because the drug company’s clinical trial of the combination didn’t assess differences in response by sex, it may have abandoned a drug that might have effectively treated chronic pain in men, if not women.

At the workshop, fascinating talks described some of the progress made in studying sex differences in stroke, depression, pain and pain perception, sleep medicine, multiple sclerosis and neuroinflammation, and more. It was clear we’ve only uncovered the tip of the iceberg.

From the start, participants acknowledge an elephant in the room — politics. Ever since 2005, when then-president of Harvard University Lawrence H. Summers drew intense public criticism for what one workshop participant called “unfortunate wording” about sex differences, researchers have felt a chilling effect on public discussion about sex differences. The workshop attendees (many — perhaps even most — of whom were women) see it as just one more obstacle that must be overcome.

Physicians who may wonder what they can do to stay up to speed on consideration of sex differences can take an online course (for Continuing Medical Education credits) created by the National Institutes of Health and the Food and Drug Administration: The Science of Sex and Gender in Human Health.”

– Sherry Boschert (@sherryboschert on Twitter)
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