The Source for Neurovascular News and Education

March 29, 2024

 

The new embolization device achieved complete revascularization in half of patients after only one pass, researchers report.

 

Eight in 10 patients undergoing revascularization for ischemic stroke secondary to large-vessel occlusion achieve an mTICI score of at least 2b within three passes of the EmboTrap stent-retriever mechanical thrombectomy device, according to the results of the ARISE II trial.

“The trial met its goal and achieved a rate of recanalization that is comparable to Solitaire and Trevo, and is now under review by the FDA for approval for use in the United States,” lead author Osama O. Zaidat, MD (Mercy St. Vincent Medical Center, Toledo, OH), told Neurovascular Exchange.

For Zaidat, what is really interesting is the very high rate of good clinical outcome, with two-thirds of patients achieving independent functional outcome. This may be related in part to the very good rate of first pass success, a proposed new measure of success for thrombectomy devices. In ARISE II, more than half of patients achieved the mTICI 2b threshold within a single pass of the device.

“This was the first study to look at outcome after each pass by an independent core lab,” Zaidat said. “This was fast, effective, successful, and meaningful recanalization.”

Improved Recanalization

ARISE II was a single-arm, multicenter study that compared the EmboTrap device (Neuravi/Cerenovus) to a composite performance goal criterion derived from a meta-analysis of trials of two competing devices: the SWIFT trial of Solitaire device (Medtronic) and the TREVO 2 trial of the Trevo device (Stryker). The 227 patients included had large-vessel occlusions and moderate-to-severe neurological deficits within 8 hours of symptom onset. The primary efficacy endpoint was an mTICI score ≥ 2b within three device passes. Results were published online recently in Stroke.

Scores of 2b or higher were achieved in 80.2% of patients, exceeding the performance goal criterion of 56% (P < 0.0001), and 65% had mTICI scores reaching 2c/3. After all interventions, which included rescue therapy with another mechanical thrombectomy device, mechanical pump aspiration, intracranial stenting, or initiation of intra-arterial tissue-type plasminogen activator, 92.5% of patients achieved mTICI scores of 2b or higher. For 51.5% of patients, this level of reperfusion was reached in the first pass.

The primary safety endpoint, a composite of symptomatic intracerebral hemorrhage or serious adverse device effects, occurred in 5.3% of patients. At 90 days, functional independence (mRS score 0-2) was achieved in 67% of patients and all-cause mortality was 9%.

Device Differences

“The current technology has made mechanic thrombectomy a standard of care for these patients,” Zaidat said. “But the current technology is limited.”

Using available treatments in patients with ischemic stroke secondary to large vessel occlusion, the rate of final complete recanalization is about 40% to 50% at the end of the procedure, Zaidat said.

In contrast, EmboTrap was “designed with the clot in mind,” he explained. The device has a slightly looser mesh at the distal end, for example, to allow for capture of any debris that escapes the clot. In addition, it has multiple chambers that allow for device/clot interaction that provides more stability as the device is dragged around curves. EmboTrap also has an inner microstent that allows for bypass of blood flow into the brain.

“The premise was to make a more effective device for removing clots,” Zaidat said. 

 


Sources:

Zaidat OO, Bozorgchami, Ribo M, et al. Primary results of the multicenter ARISE II study (analysis of revascularization in ischemic stroke with EmboTrap). Stroke. 2018;Epub ahead of print.

 

Disclosures:

  • This study was funded by Neuravi, which was subsequently acquired by Johnson & Johnson and is now a part of its subsidiary, Cerenovus.
  • Zaidat serves as a consultant for Stryker, Penumbra, Medtronic, and Neuravi and as a principal investigator for the ATLAS trial.