麻豆传媒

LOS ANGELES -- A novel stent retriever device achieved high rates of rapid, substantial reperfusion for large vessel ischemic strokes without significant safety concerns, the pivotal ARISE II study showed.

With the EmboTrap device, 80% of recipients reached the primary endpoint of more than 50% flow restored (modified TICI 2b, 2c, or 3 flow) within three passes without aspiration or other rescue therapy, including 65% with near-complete or full flow.

Notably, 51.5% of those treated had this substantial flow restored on the first pass, Osama Zaidat, MD, of St. Vincent Mercy Hospital in Toledo, Ohio, reported here at the

While the final rate of mTICI 2b-3 flow was 93%, on par with other mechanical thrombectomy trials, Zaidat noted that the high early-pass revascularization rate was a "remarkable" advance.

"That's what the trial is, it's pushing the limit," he said at a press conference. "The physicians are taking the right patients and they are taking them fast. And I think that's why I think we achieved one of the highest mRS 0-2 at 67%" compared with other studies.

The proportion of participants with a good functional outcome (modified Rankin Scale score 0-2) was 67.3% at 90 days.

J Mocco, MD, of Mount Sinai Hospital in New York City, who presented another trial at the same session reporting mRS 0-2 achieved in 52% of patients treated with an aspiration-first approach and 49% with a stentriever-first strategy, agreed that this is an important evolving area.

"Sooner and fewer is always better," he told 麻豆传媒 at the press briefing, "although I think that more important right now is to focus on the time component to getting at least TICI 2b or greater. If you can do that with one pass, obviously that will be faster. If it's two passes and it's still very quick, that's just as important. We need to focus on the quality of reperfusion ... we need to move our conversation to 2c and 3, we need to be talking about 90% of the brain getting blood flow or more, not 52%."

"For one pass efficacy, that is something that seems to be clear but does not have clear proof," he added. "However, for achieving 2c or 3 versus TICI 2b, has overwhelming proof" of impact on clinical outcomes.

"The first pass is a nuance, I think," agreed Ralph Sacco, MD, of the University of Miami, and president of the American Academy of Neurology. "It may be a predictor of how fast you can then subsequently open up the vessel, I think that's the data they need to show."

The trial included 227 patients treated with the EmboTrap device for large vessel occlusions within 8 hours of last time known well before onset of symptoms. Median time from onset to puncture was 214 minutes; median time from puncture to revascularization was 35 minutes.

The primary safety endpoint of symptomatic intracranial hemorrhage within 24 hours of treatment or other serious adverse events occurred in 5.3%. No patients died related to the procedure in the first week, although 9.0% died from any cause by day 90.

Device developer Cerenovus has applied for FDA clearance of EmboTrap based on ARISE II.

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