IMS-3 Stopped!!!!

[Neuroresident]

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Any comments?? Especially from the budding IR enthusiasts? Personally, I am happy to see this.

http://www.theheart.org/article/1390821.do

 

[DrTICI]

What is fueling your happiness?

 

[Neuroresident]

Well, the idea that without any strong evidence a large group of stroke neurologists are pushing for a treatment that is unproved and may be potentially harmful. And the only reason to push for this treatment was MONEY

 

[DrTICI]

Well, the idea that without any strong evidence a large group of stroke neurologists are pushing for a treatment that is unproved and may be potentially harmful. And the only reason to push for this treatment was MONE

Do you think the 1995 NINDS trial was going to happen if stroke neurologists did not push for IV thrombolytics? Do you doubt there was evidence that IV thrombolytics worked for stroke victims prior to 1995? I am trying to use the same logic you are using, do you follow?

We have plenty of evidence that IA thrombolytics and mechanical thrombectomy is safe and feasible and you don't have to go farther than IMS I and II if you interested in furthering your knowledge. Furthermore, IMS III itself did not find any harm or safety concerns after looking at 587 patients.So to claim that this approach is harmful is not supported.

We also have evidence that this approach works. However, we are still not good at selecting those than benefit from it. IV TPA works, but only if given within 3 hours of onset, and within 4.5 hours within a smaller subset. Nevertheless, it was still studied and failed in other trials when given to patients outside of the 3 and 4.5 hour windows. Again I invite you to use this fact when you argue against IA therapy.

Finally, I do not know where you get the idea that a lot of stroke neurologist are pushing for this for money but I suspect that you are misinformed or surrounded by bad anecdotes! Where I work and where I meet stroke neurologists in conferences, the center point is to finally find a treatment beyond IV TPA that can give further hope and better outcome to stroke victims. With this in mind, and realizing IMS III failed to finally show us the anticipated beneficial outcome, it is still hard for me to understand how someone, like yourself from a neurology background, can be happy!

Regards

 

[95439]

Umm quite the opposite actually. If anything, this was being pushed forward by Neuro IR, not stroke neurologists.

 

[daptomycin]

h

 

[neglect]

Well, the idea that without any strong evidence a large group of stroke neurologists are pushing for a treatment that is unproved and may be potentially harmful. And the only reason to push for this treatment was MONE

Do you think the 1995 NINDS trial was going to happen if stroke neurologists did not push for IV thrombolytics? Do you doubt there was evidence that IV thrombolytics worked for stroke victims prior to 1995? I am trying to use the same logic you are using, do you follow?

We have plenty of evidence that IA thrombolytics and mechanical thrombectomy is safe and feasible and you don't have to go farther than IMS I and II if you interested in furthering your knowledge. Furthermore, IMS III itself did not find any harm or safety concerns after looking at 587 patients.So to claim that this approach is harmful is not supported.

We also have evidence that this approach works. However, we are still not good at selecting those than benefit from it. IV TPA works, but only if given within 3 hours of onset, and within 4.5 hours within a smaller subset. Nevertheless, it was still studied and failed in other trials when given to patients outside of the 3 and 4.5 hour windows. Again I invite you to use this fact when you argue against IA therapy.

Finally, I do not know where you get the idea that a lot of stroke neurologist are pushing for this for money but I suspect that you are misinformed or surrounded by bad anecdotes! Where I work and where I meet stroke neurologists in conferences, the center point is to finally find a treatment beyond IV TPA that can give further hope and better outcome to stroke victims. With this in mind, and realizing IMS III failed to finally show us the anticipated beneficial outcome, it is still hard for me to understand how someone, like yourself from a neurology background, can be happy!

Regards

I share neuroresident's happiness. Why? Well for one reason is because now we know something. I greet every advance in medicine with happiness. Even if we now know something doesn't work (which we hoped would work), this represents an improvement in our knowledge, a lift out of ignorance. So the real question is why are you NOT happy? Don't answer, I already know.

The second reason is because many neurologists have been reluctant to embrace this new wave of untested stroke nonsense. We've seen the abuses that come with the toxic combination of ignorance and cults of personality forming an aggressive bravado that stains entire programs. And now it turns out that ignorance and the cults of personality were just that, and wrong, and harmful, and fed false ideas about where healing came from. Meanwhile, cautious neurologists turned out to be right. I'm sorry to say, but gloating might be unbecoming, but it is real.

The third reason is because these useless therapies spend heath care dollars that could better be spent on prevention (or on actually researching the procedures!). As it turns out, these dollars could have been better spent researching new models of stroke in trees.

So there is a lot to be quite happy about, actually.

Now things can move on from here. IA is not the solution to acute stroke, nor is IMS the final word on IA. Futility provides a platform to find out what has a chance of working. Perhaps we can one day select those who will improve with IA methods. But one thing is now for certain, the days of sending the 85 year old nursing home patient for their 5 hour cath are over. Honest data is replacing wishful thinking.

 

[DrTICI]

I share neuroresident's happiness. Why? Well for one reason is because now we know something. I greet every advance in medicine with happiness. Even if we now know something doesn't work (which we hoped would work), this represents an improvement in our knowledge, a lift out of ignorance. So the real question is why are you NOT happy? Don't answer, I already know.

I am sorry but I don't view results of medical and clinical trials as causes of happiness and unhappiness. So me not expressing happiness does not translate to what you are eluding to when you ask why am I NOT happy..so lets not get into ignorant personal assumptions please. Treat me with respect, I will do the same.
I am disappointed (vs. excited - not happy vs unhappy) that this trial failed to prove something that I have strong conviction that it works in the right setting.

As it turns out, these dollars could have been better spent researching new models of stroke in trees.

Care to show and prove to me how this trial prevented money from being spent in other areas of stroke research?

Now things can move on from here. IA is not the solution to acute stroke, nor is IMS the final word on IA. Futility provides a platform to find out what has a chance of working. Perhaps we can one day select those who will improve with IA methods.

Not only do you contradict yourself but you actually also agree with the rest of my thoughts! So thanks and cheers!

Regards

 

[neglect]

I am sorry but I don't view results of medical and clinical trials as causes of happiness and unhappiness. So me not expressing happiness does not translate to what you are eluding to when you ask why am I NOT happy..so lets not get into ignorant personal assumptions please. Treat me with respect, I will do the same.
I am disappointed (vs. excited - not happy vs unhappy) that this trial failed to prove something that I have strong conviction that it works in the right setting.

That's simply an inhuman position. But then, disappointment is a form of unhappiness. Welcome back to the human race.

Also, I am eluding nothing. It is the endovascularists who continue to perform procedures in the face of IMSIII who would elude things: Things like data, common sense, caution - to name a few. In fact, I'd say they've been eluding it for a while now.

What I'm alluding (different word) to is that people had a fixed idea about medicine based on not much of anything. IMSIII has shown their thinking to be false, it exposed a myth for superstition, and overturned a cult. That this trial had to be done (and faced resistance) and resulted in so much surprise is evidence of how far down a dead end street endovascular doctors, hospitals, and marketers took us. Well, that's done. I'm more than alluding, I'm saying that having considered this futile trial (without further data), I'd move away from doing these procedures EVER without the data to support them. Never should we put the cart before the horse again. Therapies must be shown to be effective first through randomized controlled trials first, then used.

This entire affair shows us that case series and anecdotes are junk. You say you have a strong conviction. This trial, like so many examples in medicine, has overturned many people's strong convictions. You should consider the basis for your conviction, because I find it lacking and dubious. And I find someone with a conviction that contradicts the data to be hazardous.

 

[neuro critical]

Exactly
Unfortunately, in medicine not everything that sounds "logical", is beneficial to the patient
It seems obvious that you should remove the blood from a brain with ICH, but the STICH trial proved that we were wrong
Also, reverse a-fib should be better right? Not was shown by AFFIRM
BTW, should be logical to place a stent in a intracranial stenosis, right? The SAMMPRIS trial was a total failure

This is a neurology forum, we follow evidence based data. If you want to believe that cutting/unclogging/removing resolves anything, you should go to the surgical forum and be a fool thinking that you are a blessed semi-god, protected by ignorance. Not surprisingly, in the past we had the physicians and the barbers (our dear surgeons during the 1700-1800s)

 

[neuronwangyu]

PFO closure wasted 400 millions in the past decade and I believe that the money was the driver of the train fueled by logic.

 

[RAD345]

In my humble opinion,

IMS-3's main problem was patients selection. We enrolled anybody with high NIHSS score and large artery occlusion. NO matter what perfusion showed. So the results are not in favor of intervention. Remember the original design was in 2004.

However, with more advance imaging modalities and results from DEFFUSE and DIAS studies, if patient selection being logical and realistic, I mean time-wise and territory-wise, patients still would benefit. (this is very complicated and I would be happy to explain this in more details).

This abstract presented in stroke conference this year.

Do not forget guys, that these patients are really sick when they come in and there is high chance that they develop other complications ongoing at the same time with their stroke, such as PE, MI or pneumonia.

For a lot of family members when reaches to this point, especially if the patient is really young, they are ok with disability even severe rather patient die from stroke.

With the new Solitaire stent, we already seen good results:
I had a 50 year old with complete left MCA syndrome who came in with NIHSS of 22. Complete right-sided plegia with global aphasia. Got tPA, had CTA, CTP, showed a large penumbra with two clots: one in proximal MCA and one in ICA origin. Time to puncture was 4 hours after time of onset. They retrieve both clots. The MRI 8 hours after the procedure showed a medium size stroke in the ant. internal capsule and insular cortex. She clinically is able to lift up her leg off the bed and is able to communicate with few words and follows all commands. So, this is a success story to me and family is super happy. with this exam, she might able to walk again.

So, my point is clinical trials are very well established studies and definitely help us with decision makings but at the end, they are not the only tool you should use to treat your patients. I am not going to quit treating stroke patient with IA tPA or mechanical thrombectomy because of the IMS-3 results.

Our experience in this field is less than 15 years, so I think it is too early to quit.

The same story goes along with stent placement and PFO closure.

If you are a businessman air traveller who has a PFO and has had already two strokes after flights, you want to have your PFO closed and I believe this is sound decision.

 

[danielmd06]

Our experience in this field is less than 15 years, so I think it is too early to quit.

I second this comment.

 

[neglect]

In my humble opinion,

IMS-3's main problem was patients selection. We enrolled anybody with high NIHSS score and large artery occlusion. NO matter what perfusion showed. So the results are not in favor of intervention. Remember the original design was in 2004.

However, with more advance imaging modalities and results from DEFFUSE and DIAS studies, if patient selection being logical and realistic, I mean time-wise and territory-wise, patients still would benefit. (this is very complicated and I would be happy to explain this in more details).

This abstract presented in stroke conference this year.

Do not forget guys, that these patients are really sick when they come in and there is high chance that they develop other complications ongoing at the same time with their stroke, such as PE, MI or pneumonia.

For a lot of family members when reaches to this point, especially if the patient is really young, they are ok with disability even severe rather patient die from stroke.

With the new Solitaire stent, we already seen good results:
I had a 50 year old with complete left MCA syndrome who came in with NIHSS of 22. Complete right-sided plegia with global aphasia. Got tPA, had CTA, CTP, showed a large penumbra with two clots: one in proximal MCA and one in ICA origin. Time to puncture was 4 hours after time of onset. They retrieve both clots. The MRI 8 hours after the procedure showed a medium size stroke in the ant. internal capsule and insular cortex. She clinically is able to lift up her leg off the bed and is able to communicate with few words and follows all commands. So, this is a success story to me and family is super happy. with this exam, she might able to walk again.

So, my point is clinical trials are very well established studies and definitely help us with decision makings but at the end, they are not the only tool you should use to treat your patients. I am not going to quit treating stroke patient with IA tPA or mechanical thrombectomy because of the IMS-3 results.

Our experience in this field is less than 15 years, so I think it is too early to quit.

The same story goes along with stent placement and PFO closure.

If you are a businessman air traveller who has a PFO and has had already two strokes after flights, you want to have your PFO closed and I believe this is sound decision.

1. Your PFO position is literally insane. If you are an ignoramus/non-medical person, then yes, you will be easily sold on a mechanistic narratives without data to support them. And you are declaring yourself as the man who dishonestly takes advantage of his fear. You show the data for closing the PFO, then you get to make recommendations like that. Because the rest of us here are not ignorant about these matters, nor are we driven by fear. We know that BP is the biggest risk to this man, not the PFO, and we behave accordingly and honestly.

This is really about being a doctor or not: you know, taking care of patients as a doctor, not scarring them into useless procedures. If you're doing that, then you're acting as a crook.

2. Wow, another anecdote! If IMSIII teaches us nothing else, let it teach us that these are small idiocies, pushed forward by those with agendas, that have nothing to say about what works and what doesn't.

3. IMSIII has dealt endovascular therapy a serious blow. If these treatments are ever shown to be useful, then they will be useful within a very small sliver of patients (not up to 6 hours without any other consideration) assuming quick door to recanalization time. And they might not be shown to be useful.

 

[Jalby]

If a patient is outside the IV tPa window and has a "core infarct" on diffusion imaging that is relatively small, you would be a fool not to offer them IA therapy. IV tpA should be first line, but as we all know, most patients presenting with acute stroke are not IV tPa candidates.

Anyone who thinks that IMS3 puts a nail in the coffin of acute stroke therapy needs to educate themselves as to the selection criteria and methods used in the study.

As for the person who thinks that interventionalists treating stroke with IA therapy practice purely based on anecdotes, try looking at how they do things at MGH. They have published numerous papers showing great success of IA therapy in the properly selected patient. It may not be level 1 evidence but it's surely not anecdotal. Results will get better with new devices like Solitaire.

Hopefully most neurologists are not as closed minded as most on this message board.

 

[neuro critical]

If a patient is outside the IV tPa window and has a "core infarct" on diffusion imaging that is relatively small, you would be a fool not to offer them IA therapy. IV tpA should be first line, but as we all know, most patients presenting with acute stroke are not IV tPa candidates.

Anyone who thinks that IMS3 puts a nail in the coffin of acute stroke therapy needs to educate themselves as to the selection criteria and methods used in the study.

As for the person who thinks that interventionalists treating stroke with IA therapy practice purely based on anecdotes, try looking at how they do things at MGH. They have published numerous papers showing great success of IA therapy in the properly selected patient. It may not be level 1 evidence but it's surely not anecdotal. Results will get better with new devices like Solitaire.

Hopefully most neurologists are not as closed minded as most on this message board.

Ok...anecdote is anecdote. In the Cleveland Clinic we treat at least 4-5 pts with IA a week, all of them after STAT MRI for DWI/Perf, and the team has been doing this for a looong time. Last analysis showed a very high incidence of futile recanalization. So, unless we have firm evidence, I still think it is completely experimental. BTW, the only thing that decreased was the need for hemicraniectomies.

 

[Strokeguy]

Clinical trial results break myths as well as challenge preconceived notions and biases. As someone trained and working at a major neurovascular institution, and having enrolled patients substantially in IMS3, I accept the outcome and detailed results (to follow) with humility and relief.
For pts (not eligible or failed IV TPA) with a small DWI lesion on MRI, we need to wait for MR-RESCUE results (due soon since the trial enrolled the last pt in dec 2011).
I admit that I have been biased in favor of IA therapy for pts not eligible for IV TPA or persistent occlusion despite TPA (in hind sight), largely because we did not have anything to offer except compassionate mechanical thrombectomy. But again myths, beliefs or so called strong convictions are always tested in large clinical trials (>600 pts in IMS3, larger than any acute stroke trial so far). Even though IMS was supposed to enroll 900 pts, the fact that the DSMB halted it at 656 pts should give us enough indication that we need better understanding of which pts to select for expensive IA procedures; and at the same time continue to enroll these pts in clinical trials investigating other alternative therapies. As Dr Broderick mentioned, we need to continue enrolling pts in other trials (medical or interventional like THERAPY); and that IMS3 teaches us that we cannot take every pt to the angiosuite (?? which ones if at all is being explored).
For better patient care and medical innovation I do believe that the next 12 months (till ISC 2013) will be exciting. We will have detailed analysis and subgroup analysis of both IMS 3 and MR-RESCUE to tell us which pts can (if ??) benefit from IA therapy.
I had several pts who did well anecdotally with IAT or no therapy at all. But the real question is whether this can be applied universally to every pt (which we now know that IA cannot benefit every patient). In reality the IMS3 investigators who are still blinded will do the detailed analysis and will also explore potential for any therapeutic benefit, untill then we have to wait.
I agree with everyone in this forum that IA therapy should be utilized only in a very select group of pts after careful exploration of potential benefit (which can come only from clinical trials).
The stroke community will perhaps be much more enlightened over the next several months when we have analysis and subgroup analysis from both IMS3 and MRRESCUE. Untill then lets not be hardened in favor of or against any potential therapy. I certainly expect new concepts and ideas emerging in the very near future. Untill then lets continue to provide our pts with IV TPA which is the only readily available, evidence based therapy proven in multiple nations and diverse populations; and think of ways to maximize access to this therapy. As mentioned at the AAN, let us continue to explore other therapies as well (DIAS, etc). The key lies in exploring every potential treatment which may help pts (endovascular or medical) and at the same time keep our health care system stable and sustainable.

 

[RAD345]

You are totally missing my point.

I was taking about pt super selection for the invasive treatments and interventions!

Such that PFO businessman or another pt of minewith 40 % carotid stenosis and multiple TIAs/ stroke from that artery confirmed with TCDs- EDS ( trans cranial doppler - embolic detection studies) and other imaging modalities. Pt had CEA and we all saw the clot in his small but irregular small plaque.

I'm not ingonrant nor fearful, as you were referring in your earlier post,

I feel that under special circumstances you need more data than just clinical trials. None of intervention mentioned has not decided by me alone. They have been discussed throughly in the neurovadcular presentations multiple times and after many follow ups and all the risk factors had been addressed.

All I'm saying, is that it is too early to quit.

 

[neglect]

You are totally missing my point.

I was taking about pt super selection for the invasive treatments and interventions!

Such that PFO businessman or another pt of minewith 40 % carotid stenosis and multiple TIAs/ stroke from that artery confirmed with TCDs- EDS ( trans cranial doppler - embolic detection studies) and other imaging modalities. Pt had CEA and we all saw the clot in his small but irregular small plaque.

I'm not ingonrant nor fearful, as you were referring in your earlier post,

I feel that under special circumstances you need more data than just clinical trials. None of intervention mentioned has not decided by me alone. They have been discussed throughly in the neurovadcular presentations multiple times and after many follow ups and all the risk factors had been addressed.

All I'm saying, is that it is too early to quit.

I got your point just fine. You said that you are OK with allowing a terrified patient a false belief, and failing to disabuse that belief, to the point of doing an unnecessary surgery. Since you are not ignorant or fearful, this leaves the question of your honesty.

Too early to quit trials, sure. But I think it is now late enough to now say that we should not use endovascular techniques for acute stroke until they have been shown to work in an outcome-based randomized clinical trial. The device manufacturers behavior on these issues is amazing.

 

[BlackFrancis33]

I strongly recommend the 2009 Merritt lecture, Arch Neurol 2011 68(10): 1252-6. All evidence is flawed. Absence of evidence, is not evidence of absence.

 

[RAD345]

I got your point just fine. You said that you are OK with allowing a terrified patient a false belief, and failing to disabuse that belief, to the point of doing an unnecessary surgery. Since you are not ignorant or fearful, this leaves the question of your honesty.

Pt was not terrified, it was after all negative work up and having recurrent strokes, and his job related frequent air traveling. The case discussed in Neurovascular conference in a major academic tertiary center with more than 1700 strokes a year. This is the only PFO that we closed last year. So, we did not rush anybody to anything dishonest!

Too early to quit trials, sure. But I think it is now late enough to now say that we should not use endovascular techniques for acute stroke until they have been shown to work in an outcome-based randomized clinical trial. The device manufacturers behavior on these issues is amazing.

The INR sill needed and it really works for certain patients under certain circumstances. Your position reminds me of anesthesia opponents about 160 years ago as it is a "needless luxury".
I do not how much you experience is in the care of acute stroke patients, but I see that you have not seen many happy ending cases. However, I agree that sometimes it is better to not harm patients and do not get them involved.