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CAS with embolic protection device with independent modular filter shows promise
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Use of an embolic protection system that employs an independent modular filter in carotid artery stenting was safe and effective in patients at high surgical risk, data from the WISE study suggest.
The WISE study was a prospective, multicenter, nonrandomized, open-label, single-arm study of high-risk surgical patients that evaluated the use of a device designed to deploy an independent modular distal filter for embolic protection (Wirion EPS, Gardia Medical Ltd.) using any 0.014-in. guidewire at variable distance from the target lesion.
The primary endpoint, a composite of death, stroke and MI at 30 days, was compared with a performance goal derived from historical controls. A preplanned interim analysis was performed after 120 patients were recruited and completed follow-up. Secondary endpoints included components of the primary endpoint as well as rates of device, angiographic, procedural and clinical success.
At interim analysis, the primary endpoint was lower in the WISE group compared with historical data (3.3% vs. 6.3%; P = .0008). Additionally, the researchers found numerically lower mortality (0% vs. 1.7%; P = .21), stroke (2.5% vs. 4.6%; P = .18) and MI (0.8% vs. 1.5%; P = .5) in the WISE group.
Success rates were also high, with a 99.2% device success rate, a 99.1% angiographic success rate, a 98.3% procedural success rate and a 96.6% clinical success rate, according to the data.
Results from the interim analysis showed the study met the predefined success criteria, so the study was terminated at the recommendation of the data safety monitoring board, the researchers reported.
“CAS outcomes have improved over time,” the researchers wrote, noting that data published after that used for the historical controls demonstrated lower event rates with CAS. They also highlighted other studies suggesting even further improvement in CAS.
“These data, combined with the WISE trial data, suggest that improvement in outcome could be related to improved embolic protection technology and significant advances in cognitive and technical expertise that have developed since the historical control studies were conducted,” they wrote. – by Melissa Foster
Disclosure: The study was supported by Gardia Medical Ltd. One researcher reports being the founder of Gardia Medical Ltd.
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