AAN 2011: When to Stent in Stroke
Andrew N. Wilner, MD: Hello. I'm Dr. Andrew Wilner, a neurohospitalist with the Department of Neurology at Lawrence and Memorial Hospital, New London, Connecticut. Welcome to this Medscape Peer-to-Peer discussion. It's a pleasure to be speaking today with Dr. Mark Alberts, Professor of Neurology at the Northwestern University Feinberg School of Medicine, Chicago, Illinois. Dr. Alberts is Director of the Stroke Program at Northwestern Memorial Hospital, also in Chicago. We're here today in Honolulu, at the 63rd Annual Meeting of the American Academy of Neurology, and we will be discussing stroke highlights from the conference. Dr. Alberts, thank you for joining us.
Mark J. Alberts, MD: Thank you for having me.
Dr. Wilner: There are many presentations here at the meeting, and both of us have been running around trying to see as many of them as we can. Tell me just a few of the presentations that caught your eye.
Dr. Alberts: I want to talk about 2 presentations over the next few minutes. One of them was looking at the timing of intervention for patients enrolled in the CREST [Carotid Revascularization Endartarectomy vs Stent] study. As you and the viewers may know, CREST was a prospective, randomized trial of carotid endarterectomy vs carotid stenting in people with carotid disease. Some of them were symptomatic; some of them were asymptomatic. Dr. Meschia and colleagues looked at the timing of the intervention, either the endarterectomy or the stent just for the symptomatic patients, to see if the timing made a difference.
Dr. Wilner: The timing from the stroke?
Dr. Alberts: The timing from when the patient had a stroke or transient ischemic attack (TIA) -- just for the symptomatic group. The reason that this is important to look at is that previous studies, such as NASCET [North American Symptomatic Carotid Endarterectomy Trial], have suggested that surgery should be done within 2 weeks of a TIA or a stroke if they have a symptomatic lesion. But, frankly, many surgeons are reluctant to intervene in that short period of time because they are concerned about increased risk for complications from doing surgery so soon after a stroke. What the CREST investigators found, looking at over 1000 patients, is that basically there was no difference in periprocedural complications of either surgery or stenting as a function of time or time delay from the patient's clinical event. This is good. It means that, perhaps, we do have the "tincture of time" to wait. My general philosophy has always been if you are going to intervene and if the patient is relatively stable, intervene sooner rather than later, so that they don't run the risk of having another event. However, it also tells us that if you don't think that the patient is quite stable or you want to wait maybe an extra week or 2, you have that luxury of time, if it would make the surgeon or the stenter or the patient feel more comfortable. That was a major result, and CREST is a fairly contemporary study. It was just reported last year. It does give us some added proof that it's okay to intervene early, but it's also okay to wait a little while.
Dr. Wilner: For the patient who had the stroke or TIA, all of a sudden they are sick. Maybe they were perfectly well, as far as they knew, and now the doctor is saying, "We're going to do this carotid endarterectomy or a stent." Some may not psychologically be ready to have it done immediately. Also, some may have uncontrolled hypertension. Medical issues may need to be addressed, and that would argue for waiting a little while. On the other hand, I completely agree that every day that you wait is another day that a stroke might occur.
Dr. Alberts: Absolutely right. It's a little bit like playing Russian roulette, only with the brain, and we don't like to do that with the brain. Some patients just want to get over that initial stroke; maybe they want to spend a week or 2 in rehabilitation and get stronger. You brought up a very good point about using that time period to get their risk factors under control, get their hypertension, diabetes, and lipid disorders under control. Either way, at least based on the CREST results, seems reasonable and acceptable to me.
Dr. Wilner: Do you think these findings are strong enough that it could become a guideline?
Dr. Alberts: I certainly think it could be incorporated in the guidelines because CREST was a large study -- more than 2000 patients were enrolled and randomly assigned -- and the procedures were performed by some of the top surgeons and stenters in the country. The findings were fairly robust.
Dr. Wilner: That's really good news. It's nice to have something you can hang your hat on and tell the patient.
Dr. Alberts: Exactly.
Dr. Wilner: And that sounds useful. What was the other study that you were referring to?
Dr. Alberts: The other study that I wanted to talk about was not presented at this neurology meeting, but it came out during the meeting in an unrelated way, and that was the SAMMPRIS [Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis] trial. SAMMPRIS is a National Institutes of Health (NIH)-sponsored trial of people with symptomatic, intracranial stenosis -- stenosis of the blood vessel within their brain. Those patients were randomly assigned to stenting with the Wingspanâ„¢ device (Boston Scientific Corporation, Natick, Massachusetts) plus best medical therapy vs just best medical therapy. The Data Safety Monitoring Board (DSMB) stopped the study early after about 729 patients were enrolled. They stopped the study early because of the higher rate of 30-day stroke and or death in the stent patients vs the patients who received just medical therapy. The event rates were about 14% for the stent group and about 6% for the medical therapy group.
These event rates were different from what had been anticipated, but it doesn't matter what you anticipate in clinical trials. It matters what the results are and what the data show. The DSMB and the executive committee of the study looked at the results and saw an imbalance in early deaths, with more early deaths in the stent group vs the best medical therapy group, and they decided to stop the study. This decision has been criticized by some people who have said, "Maybe the 30-day group rates were out of balance, but maybe in the long term, the patients who received stenting did better?" They did look at that, to the extent that they could, and found, overall, no difference in terms of the longer-term stroke rates. Upfront, however, the stent patients paid a higher price in terms of the higher rate of stroke and death. So this study was stopped and it's a disappointment to many people.
Dr. Wilner: As physicians, our primary goal is the protection and the care of the patient. If the data strongly suggest that this intervention is dangerous, then I think that the investigators had no choice. I wonder if it's because we are just not too good at stenting yet. Stenting in the middle cerebral artery is not the same thing as stenting in the femoral artery or a stent in the heart. Maybe there are technical issues and procedure needs to be refined in a canine model or somewhere else before another clinical trial approaches this. I had a patient recently with middle cerebral artery stenosis and it was very frustrating. It's like, if that was your carotid, we could fix it, but up there, I don't know. This study suggests that aggressive medical therapy, which controls diabetes, blood pressure, and lipids, should be the focus for physicians. It can have surprisingly good results.
Dr. Alberts: It can, but we do know from previous studies that these patients with high-grade symptomatic intracranial disease are at very high risk of having subsequent strokes. Some have said this risk is in excess of 20%-25% over 2 years. This is a bad disease, no matter what you do, stent or best medical therapy. You bring up a good point and that is that we are still on the steep part of the learning curve in terms of who to intervene with, when to intervene, and how to intervene. They did use the Wingspan stenting apparatus, which is supposed to be pretty good. However, we know that stenting in the heart is much different from stenting in the brain. The blood vessels are different. The organ is different. The ability in how these vessels react to being worked on with a stent and angioplasty is much different in cerebral vessels vs cardiac vessels. So, I agree, we are on the steep part of the learning curve. On the other hand, SAMMPRIS was an NIH-sponsored study. The DSMB took their charge very seriously. They looked at all the available data, and the investigators and the executive committee of the study agreed with the decision to stop the study. So that's where we stand now in April of 2011.
Dr. Wilner: Well, thank you very much, Dr. Alberts, for these really very helpful insights and thanks for joining Medscape at the 63rd Annual Meeting of the American Academy of Neurology in Honolulu, Hawaii.
Dr. Alberts: Thank you very much.
Introduction
Andrew N. Wilner, MD: Hello. I'm Dr. Andrew Wilner, a neurohospitalist with the Department of Neurology at Lawrence and Memorial Hospital, New London, Connecticut. Welcome to this Medscape Peer-to-Peer discussion. It's a pleasure to be speaking today with Dr. Mark Alberts, Professor of Neurology at the Northwestern University Feinberg School of Medicine, Chicago, Illinois. Dr. Alberts is Director of the Stroke Program at Northwestern Memorial Hospital, also in Chicago. We're here today in Honolulu, at the 63rd Annual Meeting of the American Academy of Neurology, and we will be discussing stroke highlights from the conference. Dr. Alberts, thank you for joining us.
Mark J. Alberts, MD: Thank you for having me.
Dr. Wilner: There are many presentations here at the meeting, and both of us have been running around trying to see as many of them as we can. Tell me just a few of the presentations that caught your eye.
Symptomatic Stroke: When to Intervene
Dr. Alberts: I want to talk about 2 presentations over the next few minutes. One of them was looking at the timing of intervention for patients enrolled in the CREST [Carotid Revascularization Endartarectomy vs Stent] study. As you and the viewers may know, CREST was a prospective, randomized trial of carotid endarterectomy vs carotid stenting in people with carotid disease. Some of them were symptomatic; some of them were asymptomatic. Dr. Meschia and colleagues looked at the timing of the intervention, either the endarterectomy or the stent just for the symptomatic patients, to see if the timing made a difference.
Dr. Wilner: The timing from the stroke?
Dr. Alberts: The timing from when the patient had a stroke or transient ischemic attack (TIA) -- just for the symptomatic group. The reason that this is important to look at is that previous studies, such as NASCET [North American Symptomatic Carotid Endarterectomy Trial], have suggested that surgery should be done within 2 weeks of a TIA or a stroke if they have a symptomatic lesion. But, frankly, many surgeons are reluctant to intervene in that short period of time because they are concerned about increased risk for complications from doing surgery so soon after a stroke. What the CREST investigators found, looking at over 1000 patients, is that basically there was no difference in periprocedural complications of either surgery or stenting as a function of time or time delay from the patient's clinical event. This is good. It means that, perhaps, we do have the "tincture of time" to wait. My general philosophy has always been if you are going to intervene and if the patient is relatively stable, intervene sooner rather than later, so that they don't run the risk of having another event. However, it also tells us that if you don't think that the patient is quite stable or you want to wait maybe an extra week or 2, you have that luxury of time, if it would make the surgeon or the stenter or the patient feel more comfortable. That was a major result, and CREST is a fairly contemporary study. It was just reported last year. It does give us some added proof that it's okay to intervene early, but it's also okay to wait a little while.
Dr. Wilner: For the patient who had the stroke or TIA, all of a sudden they are sick. Maybe they were perfectly well, as far as they knew, and now the doctor is saying, "We're going to do this carotid endarterectomy or a stent." Some may not psychologically be ready to have it done immediately. Also, some may have uncontrolled hypertension. Medical issues may need to be addressed, and that would argue for waiting a little while. On the other hand, I completely agree that every day that you wait is another day that a stroke might occur.
Dr. Alberts: Absolutely right. It's a little bit like playing Russian roulette, only with the brain, and we don't like to do that with the brain. Some patients just want to get over that initial stroke; maybe they want to spend a week or 2 in rehabilitation and get stronger. You brought up a very good point about using that time period to get their risk factors under control, get their hypertension, diabetes, and lipid disorders under control. Either way, at least based on the CREST results, seems reasonable and acceptable to me.
Dr. Wilner: Do you think these findings are strong enough that it could become a guideline?
Dr. Alberts: I certainly think it could be incorporated in the guidelines because CREST was a large study -- more than 2000 patients were enrolled and randomly assigned -- and the procedures were performed by some of the top surgeons and stenters in the country. The findings were fairly robust.
Dr. Wilner: That's really good news. It's nice to have something you can hang your hat on and tell the patient.
Dr. Alberts: Exactly.
Dr. Wilner: And that sounds useful. What was the other study that you were referring to?
SAMMPRIS
Dr. Alberts: The other study that I wanted to talk about was not presented at this neurology meeting, but it came out during the meeting in an unrelated way, and that was the SAMMPRIS [Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis] trial. SAMMPRIS is a National Institutes of Health (NIH)-sponsored trial of people with symptomatic, intracranial stenosis -- stenosis of the blood vessel within their brain. Those patients were randomly assigned to stenting with the Wingspanâ„¢ device (Boston Scientific Corporation, Natick, Massachusetts) plus best medical therapy vs just best medical therapy. The Data Safety Monitoring Board (DSMB) stopped the study early after about 729 patients were enrolled. They stopped the study early because of the higher rate of 30-day stroke and or death in the stent patients vs the patients who received just medical therapy. The event rates were about 14% for the stent group and about 6% for the medical therapy group.
These event rates were different from what had been anticipated, but it doesn't matter what you anticipate in clinical trials. It matters what the results are and what the data show. The DSMB and the executive committee of the study looked at the results and saw an imbalance in early deaths, with more early deaths in the stent group vs the best medical therapy group, and they decided to stop the study. This decision has been criticized by some people who have said, "Maybe the 30-day group rates were out of balance, but maybe in the long term, the patients who received stenting did better?" They did look at that, to the extent that they could, and found, overall, no difference in terms of the longer-term stroke rates. Upfront, however, the stent patients paid a higher price in terms of the higher rate of stroke and death. So this study was stopped and it's a disappointment to many people.
Dr. Wilner: As physicians, our primary goal is the protection and the care of the patient. If the data strongly suggest that this intervention is dangerous, then I think that the investigators had no choice. I wonder if it's because we are just not too good at stenting yet. Stenting in the middle cerebral artery is not the same thing as stenting in the femoral artery or a stent in the heart. Maybe there are technical issues and procedure needs to be refined in a canine model or somewhere else before another clinical trial approaches this. I had a patient recently with middle cerebral artery stenosis and it was very frustrating. It's like, if that was your carotid, we could fix it, but up there, I don't know. This study suggests that aggressive medical therapy, which controls diabetes, blood pressure, and lipids, should be the focus for physicians. It can have surprisingly good results.
Dr. Alberts: It can, but we do know from previous studies that these patients with high-grade symptomatic intracranial disease are at very high risk of having subsequent strokes. Some have said this risk is in excess of 20%-25% over 2 years. This is a bad disease, no matter what you do, stent or best medical therapy. You bring up a good point and that is that we are still on the steep part of the learning curve in terms of who to intervene with, when to intervene, and how to intervene. They did use the Wingspan stenting apparatus, which is supposed to be pretty good. However, we know that stenting in the heart is much different from stenting in the brain. The blood vessels are different. The organ is different. The ability in how these vessels react to being worked on with a stent and angioplasty is much different in cerebral vessels vs cardiac vessels. So, I agree, we are on the steep part of the learning curve. On the other hand, SAMMPRIS was an NIH-sponsored study. The DSMB took their charge very seriously. They looked at all the available data, and the investigators and the executive committee of the study agreed with the decision to stop the study. So that's where we stand now in April of 2011.
Dr. Wilner: Well, thank you very much, Dr. Alberts, for these really very helpful insights and thanks for joining Medscape at the 63rd Annual Meeting of the American Academy of Neurology in Honolulu, Hawaii.
Dr. Alberts: Thank you very much.
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