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ARISE II: Novel revascularization device successfully treats large vessel occlusion
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Patients with anterior and posterior circulation proximal large vessel occlusion who had an acute ischemic stroke and underwent revascularization with a novel device had high rates of reperfusion and favorable outcomes, according to the ARISE II trial presented at the International Stroke Conference.
“Newer novel stent retrievers may increase the chance of full revascularization of cerebral large vessel occlusion leading to brain perfusion,” Osama Zaidat, MD, MS, FAHA, FAAN, medical director of neuroscience and stroke at Mercy Health-St. Vincent’s Hospital in Toledo, Ohio, told Cardiology Today’s Intervention.
Researchers analyzed data from 227 patients (mean age, 68 years; 46% men) with anterior and posterior circulation proximal large vessel occlusion who presented with acute ischemic stroke. Patients who met criteria such as a hypertensive emergency with a systolic BP of at least 220 mm Hg were excluded.
Revascularization was performed using a novel device (EmboTrap, Neuravi/Cerenovus).
“The EmboTrap device came with this ... unique, innovative design,” Zaidat said during a press conference. “It has this inner channel that allows bypass while the device is open. It has five chambers that interact with the clot and grab it better in principle. It has this distal part that has extensive mesh that keeps the clot in place and it does not fragment.”
The primary efficacy endpoint of interest was a modified treatment in cerebral ischemia score between 2b and 3 within three passes of the device without rescue. The primary safety endpoint of interest was a composite of symptomatic intracerebral hemorrhage within 24 hours after the procedure and other serious adverse device events. Secondary endpoints of interest included procedure and time-to-treat, good clinical outcome at 90 days and all-cause mortality at 90 days.
“The key thing here is that a core lab, for the first time for an innovative design, adjudicated the outcome after each single pass,” Zaidat said.
Patients were followed up at 24 hours, 7 days and 90 days.
Atrial fibrillation was seen in 39.6% of patients at baseline.
Patients were treated within 243 minutes from stroke onset to revascularization, 214 minutes from onset to puncture, 60 minutes from entrance to the ED to puncture and 35 minutes from puncture to revascularization. The time to treat was 24 minutes.
IV tissue plasminogen activator failure occurred in 52.9% of patients, and a balloon guide catheter was used in 73.6% of patients.
“Three out of four patients have balloon guide catheter use, one of the highest in the literature,” Zaidat said. “That may play a factor into the final study result.”
Within three passes of the device, successful revascularization occurred in 80% of patients, and 65% of patients achieved a modified treatment in cerebral ischemia score between 2c and 3.
“This is remarkable in our advancement in the field,” Zaidat said. “That’s what we wanted.”
A score of 2b, 2c or 3 was achieved in 51.5% of patients after the first pass, and 93% achieved it during final revascularization.
At 90 days, 67.3% of patients achieved a modified Rankin scale score between 0 and 2, which means functionally independent, and a score between 0 and 1, signifying a near return to full normal function with no disability, was reached by 51.6% of patients.
Symptomatic intracerebral hemorrhage within 24 hours occurred in 5.3% of patients, and all-cause mortality at 90 days occurred in 9% of the group. Embolization into new territory was performed in 6.6% of patients. Rescue therapy was used in 19.4% of patients.
“[These findings] may lead to more adaptations of the newer devices,” Zaidat told Cardiology Today’s Intervention. – by Darlene Dobkowski
Reference:
Zaidat O, et al. LB5. Presented at: International Stroke Conference; Jan. 23-26, 2018; Los Angeles.
Disclosure: The study was sponsored by Neuravi. Zaidat reports he is a consultant for Neuravi, now part of Cerenovus, a Johnson & Johnson company.
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Larry B. Goldstein, MD, FAAN, FANA, FAHA
The study was designed to secure 510(k) clearance of the EmboTrap Revascularization Device. Eighty percent of those treated had successful recanalization, comparing favorably with previous studies of other devices. There were no concurrent controls, so it is difficult to conclude more.
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