New NINDS study - impact on future of interventional neurology?

[riverbear]

Hi all,

I'm a 3rd yr med student thinking it about doing a neurology residency with the goal of pursuing a stroke fellowship and possibly INR. However, I just came across this article, which showed a significantly higher mortality rate in stented patients vs patients who received medical therapy alone. Enrollment in the study was stopped because of the findings:

http://www.nlm.nih.gov/databases/alerts/intracranial_arterial_stenosis.html

For those of you more familiar with interventional neurology, how much of an impact will this have on the future of INR? Also, do you know of any other studies regarding outcomes of INR procedures?

Thanks in advance.

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[typhoonegator]

It will certainly have an impact to some degree, although like all studies there are some flaws. All in all, thank god we're getting some results back on these largely unproven therapeutic modalities.

However, there is an awful lot more to neuroIR than putting Wingspan stents in MCAs, and there are definitely situations in which this device could still be considered (outside of the criteria defined in the study). I'm not a huge IR guy, but I don't see the field drying up over SAMMPRIS. There are multiple ongoing trials of carotid stents, MERCI/Penumbra (MR-RESCUE), etc. that are in the pipeline and/or recruiting patients. Hopefully the next few years will see an explosion in data on how best to apply these tools from an outcomes/mortality perspective.

 

[Strokeguy]

Quoting my prior post -

The last few posts about interventional neurology likely created some confusion about the field. The subspeciality has a strong base regardless. Let me clarify and also inform.
First, about SAMMPRIS, it clearly shows that compared to current optimal medical therapy, angioplasty and stenting with the ‘Wingspan-Gateway system’ is more risky at 30 days. That being said, most stroke experts await the long term results as well as detailed analysis. The trial was stopped on recommendations from the DSMB. This does NOT mean intracranial angioplasty and stenting is dead. There are always those pts who ‘fail optimal medical therapy’; and these are the ones who do need endovascular treatment. SAMMPRIS clearly shows that Wingspan stent with the gateway balloon is more risky. Like all endovasc therapies, results to a large extent depend on how good/safe the device is (considering that all operators in a clinical trial are experts). This stent has a high outward radial force and may not be the best one available. There is another trial going on that uses a balloon mounted stent. Unlike medical therapies, devices are extremely technology dependent. A case in point is comparing the initial GDC coils and the ones currenty available.
Lets say, we don’t want to stent, then also there is always a safer option of balloon angioplasty alone. Till date, only med therapy failures were stented. Now we are not sure with wingspan. Had SAMMPRIS showed otherwise, we would be recommending stenting for all symptomatic intracranial stenosis, which now we wouldn’t and shouldn’t. Why use a more dangerous system. But for ‘med failures’ balloon angioplasty remains a viable option. There is better technology available and evolving.
Many people are not aware of the results of SENTIS. This trial used Neuroflo – a flow diversion device within 14 hours of stroke onset. This device diverted flow to the brain by reducing flow in the aorta by 70%. A balloon was inflated above the renal artery for 45 min and then below it again for 45 min. They also enrolled over 500 pts; and showed 30% decreased stroke mortality with this device. Patients did better with the device, but did not reach the primary end point of 90 day mrs0-1 (which the investigators felt was unrealistic, since all stroke trials use 0-2 for good outcomes). NO (or very few) stroke pts are expected to be absolutely normal in 90 days.
You can all do the math – how many pts can be eligible for therapy with this system versus how many ‘have been excluded from wingspan stenting’ with our current evidence. We have a large number of ischemic strokes with very few pts having intracranial stenosis in the US.

Let me also clarify – CREST did NOT show that surgery is better than stenting. CREST demonstrated NON-INFERIORITY of stenting compared to surgery. CREST also showed that stenting is better in younger pts and surgery better in older (if there was no risk for anesthesia). Data shows that carotid stenting for symptomatic disease has increased significantly following CREST. If you all remember that prior trials (including European) showed stenting inferior to surgery. This again has to do with evolution of ‘technology’; newer generation devices were used in CREST. This should be kept in mind with regards to intracranial stenting as well. We aren’t there yet with wingspan.
I infact feel relieved that SAMMPRIS showed that wingspan-gateway is not good enough; at least in the short term. So this remains a work in progress.

‘The more acute stroke cases that go to interventional, the more M&M.’ This could not have been further from the truth. Patients that require endovasc treatment have severe strokes that have the worst natural history. MRRESCUE and IMS-3 are still on; but we have a lot of data on utility of interventional therapy. Look at the editorial in the April edition of Stroke. There is also a prospective study - Bridging Intravenous–Intra-Arterial Rescue Strategy Increases Recanalization and the Likelihood of a Good Outcome in Nonresponder Intravenous Tissue Plasminogen Activator-Treated Patients: A Case–Control Study
Marta Rubiera, Marc Ribo, Jorge Pagola, Pilar Coscojuela, David Rodriguez-Luna, Olga Maisterra, Bernardo Ibarra, Socorro Piñeiro, Pilar Meler, Francisco J. Romero, Jose Alvarez-Sabin, and Carlos A. Molina
Stroke. 2011;42:993-997; published online before print March 3 2011, doi:10.1161/STROKEAHA.110.597104

T here is a new retrievable stent device (Stentriever) which has by far the best recan rates and also opens the artery much earlier than Merci or Penumbra.
I think interventional neurology is a dynamic and futuristic field. There will always be procedures/devices that are undesirable and there will be many others that are useful. Technological advances also make a difference.