Eric Sauvageau, MD, Co-Director of the Stroke and Cerebrovascular Center at Baptist Health of Northeast Florida, Surgical Director of Neuro-Oncology, talks about a new treatment to save brain cells in stroke patients.
What are you and your colleagues looking at in this trial?
SAUVAGEAU: The ESCAPE trial is a trial that was designed by a group in Calgary, Canada. If we look at stroke treatment, we’ve seen a lot of improvement over the last decade. The first thing that was approved and shows benefit was a clot buster called TPA. We know it’s working well for small clots, but the analogy I like to use is it’s like a plumbing system. If you have a bit of blockage in your pipes at home, Drano is going to do the trick. But if it’s a big blockage, that’s not going to work. So, to address the bigger blockage, we have a way to go in with something like a snake to remove those clots within the brain. It’s called a thrombectomy and has shown to be extremely effective. It’s one of the treatments in medicine that is the most effective as far as impacting the quality of life of people and making sure they are rebounding and doing well. The problem is that there’s still patients who show up to the hospital too late. When somebody is found to have stroke symptoms between the time the treatment is given or done, there’s also a delay there. For many years one treatment that people have been trying to work on is what we call neuroprotection. What it tries to do is keep those cells that are not getting oxygen and blood in the brain to be in hibernation or be able to stay still and not die in the process. There are a lot of drugs that until now were really promising in rats and mice but did not pan out to be effective in humans. So, the ESCAPE NA1 was trying one of those drugs that had shown promise in animals before, and shown promise in humans, had been tested in the context of angiogram and showed that it decreased the risk of lesion. It was what we call a randomized trial, which means that when patients come, they were either getting the placebo or the ESCAPE NA1 drugs. The results showed that there was a trend towards improvement in outcome in the people who did not receive the clot busters. Interestingly, pharmacologically, and biologically, it appears that people who got the clot buster, there was an impact on the effect of the escape NA1 drug. There is a study being done now and we’re part of it, probably about to start in September, that’s going to specifically exclude the people who got TPA because we feel the effect on those patients was not present but present in the other patients. So, looking at patients who did not get the TPA and then half of the patients will receive the escape NA1 drug and the other half will get the placebo to confirm that it’s really effective. The exciting thing about this drug is if it turned out to show positive in that setting, could you imagine that people who were found highly suspicious or at least suspected to have a stroke, could be given this drug by the EMS crew. And hopefully that would put the brain in hibernation. This way they could receive the treatment in the hospital, and during that transport time the brain would have been preserved, making sure there is no more cell dying during that time. So, it’s really exciting in that sense because if it confirms that it’s positive in this patient population, then you could even extend that to think about people with cardiac arrest that eventually will have brain damage. Could this population even benefit from this? There’s in fact a current study that is being done in Canada and western Canada looking specifically at this drug being administered by the EMS crew to see if it would pan out to be effective.
With the current trial, or the previous trial, are there any numbers as to how effective it was? Or a percentage of people you found it did preserve the cells?
SAUVAGEAU: So, anecdotally, there’s a patient we treated that we would have expected a larger stroke. It turned out they had a small core infarct. A lot of the patients in the trial got TPA. So, when we put all those patients combined, the effect did not turn out to be as spectacular as we were hoping. When we removed that patient population, it did seem that there was a benefit. The problem is that when studies are designed to include everyone, then those sub-analysis lose their power. Even if it’s a positive trend, the study needs to be repeated excluding those patients that do not seem to benefit as much.
Is there a particular group of people this new treatment wouldn’t be the best option for?
SAUVAGEAU: Yes. The patient with clot busters seems like this is not going to be an adjunctive to them that will be beneficial. There is no dramatic side effect or dangerous side effect of this drug. That’s why it’s so exciting if it turned out to be positive or if we can eventually expand to the population who benefit from this, that would be a drug that would have a huge impact.
If the results come back that this new medication is effective, if somebody has a stroke, would it depend on the time they get the TPA or this new drug?
SAUVAGEAU: Yes. As the treatments are evolving and we’re getting new options, one of our jobs is to define what is the best route to go with all those drugs. We know, that as far as TPA, there’s patients that most likely will continue to benefit from it. When it’s a larger vessel and we need to go with the thrombectomy device, there’s a study currently looking at whether we should forego TPA in those patients that eventually will need the thrombectomy. It’s similar to what happened in cardiology over the years in the sense that early on they had the clot buster for the heart and would give that. But eventually they realized that the clot buster was not beneficial if there was a way to go there and put a stent right away. Now, it’s really rare that people get clot busters for the heart. As we’re learning more about the brain, and as more treatments are available, the treatment paradigm is changing as well. So at this point, TPA remains the gold standard. Thrombectomy remains the gold standard. We’re never not going to give the TPA, even if we think that the chance of that working is low because it’s a large vessel that is blocked. But those paradigms could change with time. We’re in the middle of this which is quite exciting because that treatment modality would not have been dreamt about a few years ago. Now, if the ESCAPE trial opens the door to all those neuroprotective agents, there’s probably others that may show some benefit down the road and all of them will probably have a patient population that benefit from that.
What is the longest time span someone is eligible to get TPA? And what’s the percentage of patients that are not able to?
SAUVAGEAU: Most patients are not eligible for TPA. We know TPA is effective when it’s given within three hours and in some patients within four and a half hours, depending on a few criteria. So, there is contraindication to TPA. For example, if you’ve got a recent surgery, the risk of bleeding outweighs the benefit of the TPA. But the main reason, unfortunately, is people who have a stroke will still consult too late. By opposition to heart attack, a lot of times strokes are not painful. Initially, the symptoms could be mild. People could just have numbness, or a bit of weakness and a lot of time people will try to justify that maybe I slept wrong or something. People will neglect coming straight away to the hospital. One of the jobs as far as health care providers goes, is to make sure people are educated know there’s treatment available.
With those brain cells dying, what could that mean for somebody’s quality of life with this neuroprotective drug?
SAUVAGEAU: As far as the impact of a stroke on a patient, it depends where the blockage is. A lot of times it will affect what we call the middle cerebral artery, which means it’s going to affect their movement on the other side of their body. If it’s on the left side, most people are what we call left side dominant, the speech is on the left. Most of the time, if it’s on the left, people have significant speech problem. So, by everything that we could provide to decrease the number of cells that are dying or preserving those cells, protecting those cells like the molecule of ESCAPENA1, we decrease the deficit in those patients by decreasing the amounts of cells that are dying. We decrease the motor deficit and decrease the speech deficit. We have an impact on them directly and increase their chance of them going back home with less disability.
Is there anything I didn’t ask that you feel people should know?
SAUVAGEAU: The signs and symptoms of stroke is always important that people are aware of. Even a lot of physicians are not fully aware of all the treatments available for stroke. It’s literally life-changing all the treatments that have occurred over the last decade. There’s a lot of patients that in the past would have ended up in a nursing home and now they’ll be home a day or two later. Sometimes it’s happened so quickly that they don’t realize how lucky they’ve been. And to some extent, it’s prevented them to make some risk factor modifications like smoking because they don’t realize how lucky they’ve been in the first place.
Who’s at higher risk for getting a stroke?
SAUVAGEAU: The thing that is purely in your control and you can address is family history. Things like irregular heartbeat. If you have that, atrial fibrillation, we know by taking a blood thinner it will decrease the risk of having a stroke. High cholesterol we know damages the arteries and increases the risk of plaque. There’s a really good drug to lower that as well as diet changes. There’s a lot of behavioral changes that could help and a lot of medication that could help as well in the interim to get rid of bad habits. Diabetes is the same thing that can be addressed and treated. So, all of those things that, even if you have them, doesn’t mean that you need to accept the risks that come with them. You can be proactive and make sure to control those factors.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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