EDAS Surgery May Help Prevent Repeat Strokes from Brain Plaques

I have no clue if I have plaque in my brain arteries, I know I have some in a couple of coronary arteries and 1 carotid artery is completely closed up. You'll have to ask your doctor how to determine if you have brain plaque and are a candidate for this.

EDAS Surgery May Help Prevent Repeat Strokes from Brain Plaques

Early phase study showed potentially lower recurrence, death risk

• by Crystal Phend, Senior Associate Editor, MedPage Today October 18, 2018
• This article is a collaboration between MedPage Today® and:
  

For patients with a recent stroke or transient ischemic attack (TIA) attributed to intracranial atherosclerosis, a procedure to redirect scalp or dural arteries into the brain appeared to safely reduce risk of recurrent events in a phase IIa trial.
The procedure -- encephaloduroarteriosynangiosis (EDAS), a version of the procedure done for Moyamoya disease but with modifications to maintain cerebral perfusion -- was associated with a 9.6% composite 30-day rate of death or stroke of any cause or any ischemic stroke around the atherosclerotic artery by 1 year after surgery, as adjudicated by stroke neurologists.
By comparison, the rate had been 17.3% in a group with the same characteristics but treated with medicine alone in the SAMMPRIS trial.
That 7.7% absolute difference met criteria for non-futility, warranting a phase III trial for the surgery in this population that accounts for approximately 10% of ischemic strokes, Nestor Gonzalez, MD, of Cedars-Sinai Medical Center in Los Angeles, reported at the World Stroke Congress in Montreal.
A less conservative comparison using propensity-score matching for a larger group of medically-treated patients as controls suggested as much as a 12% absolute risk reduction in the primary endpoint, again within the bounds set for significance.
"The results are better than we expected," Gonzalez said. However, he cautioned, "as promising as the results are, they are not definitive results and they need to be tested in a phase III randomized clinical trial."
Seemant Chaturvedi, MD, of the University of Miami, agreed that such a trial will be needed but called for further testing first.
"Patients with intracranial stenosis who are refractory to best medical management are a high risk group. The 10% event rate at 1 year is not trivial," he told MedPage Today. "I would like to see an expanded multi-center trial with a diverse group of surgeons. We need to see if a low complication rate can be achieved in a broader setting. I think it is premature for a phase III trial."
But also commenting on the trial, Mark Alberts, MD, of the Ayer Neuroscience Institute at Hartford Healthcare in Connecticut, argued that "there are not a lot of other good options for these patients. It makes sense to me to really explore this in a larger study format.
"If the larger study is successful, it will certainly redefine the standard of care for these patients and provide these patients with a very valuable surgical option."
Two of the 52 patients (3.8%) in Gonzalez's ERSIAS trial had surgical wound dehiscence that required further surgery for debridement and closure. But other adverse events were generally mild, there were no cases of cerebral hemorrhage or cerebral edema, and the overall safety profile was "very good," he told MedPage Today.
The single-arm trial included patients with symptomatic 70% or greater atherosclerotic stenosis of the intracranial internal carotid artery or middle cerebral artery and poor to fair collaterals seen on catheter-based angiography. All patients got intensive vascular risk factor management by SAMMPRIS protocols and aspirin as antiplatelet therapy perioperatively.
Functional outcomes shifted toward less impairment by 1 year compared with baseline in the EDAS-treated cohort, as measured by modified Rankin scale scores. Cognitive assessments among those with no aphasia or neglect showed results on par with SAMMPRIS at 12 months and less than the expected decline after a stroke or TIA.
Among those with angiographic follow-up, more than 97% had Perren grade 2 or better neovascularization, and about 68% had good collaterals (ASITN grades 3-4).
A phase III trial is in the planning stages, Gonzalez said.

The study was funded by the NINDS and Ruth and Raymond Stotter Endowment.
Gonzalez disclosed no relevant relationships with industry.

last updated 10.25.2018

• Primary Source

  World Stroke Congress

  Source Reference: Gonzalez NR, et al "EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive disease. Phase IIa Study" WSC 2018.