Carotid artery stent system tied to low event rates at 1 year: PERFORMANCE II
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Key takeaways:
- A carotid artery stenting system was linked to low event rates at 1 year.
- The device consists of an embolic protection filter, a balloon and a stent mounted on a single delivery system.
An integrated carotid artery stent system was associated with the lowest 1-year event rates in any well-powered, multicenter carotid revascularization trial, according to data presented at VIVA.23.
The event rates were even lower than those for trials of carotid endarterectomy and transcarotid artery revascularization, researchers reported.
“This is a 3-in-1 system that has a 40-micron pore filter, the balloon and the stent mounted on a 6F delivery system,” William A. Gray, MD, system chief for cardiovascular services at Main Line Health and co-director of the Lankenau Heart Institute in Wynnewood, Pennsylvania, said during a presentation of the PERFORMANCE II trial evaluating the carotid stenting system (Neurogard Integrated Embolic Protection [IEP] system, Contego Medical). “The stent is purpose-built for the carotid application. It has a closed-cell design with a novel nitinol construction that allows it to maintain flexibility, and leverages the established long-term durability of nitinol in the carotid territory . Its asymmetric hourglass shape allows for optimized radial strength throughout the stent.”
The trial included 305 patients with bifurcation carotid artery stenosis (≥ 50% stenosis if symptomatic or ≥ 80% stenosis if asymptomatic) at elevated risk for adverse events following carotid endarterectomy.
The primary outcome was periprocedural death, stroke or MI within 30 days plus ipsilateral stroke from 31 days to 12 months, compared with a pre-specified performance goal of 13.8%, Gray said.
Among the cohort, the mean age was 70 years, 66% were men and 20% were symptomatic.
The rate of death, stroke or MI at 30 days was 2.3% in the intention-to-treat analysis and 1.97% in the per-protocol analysis, the latter of which excluded one patient who was in a hypercoagulable state requiring chronic anticoagulation and should not have been included in the trial, Gray said during the presentation.
The one patient who died on day 30 had three-vessel CAD and died of CV causes unrelated to the procedure, he said.Importantly, the rate of stroke at 30 days was 1.31% in the intention-to-treat cohort and 0.98% in the per-protocol cohort, Gray said. There were no major strokes or contralateral strokes at 30 days. The 30-day stroke rate was lower than that observed in any trial of carotid endarterectomy or transcarotid artery revascularization (TCAR), he said.
The rate of all strokes at 30 days plus ipsilateral strokes from day 31 to12 months was 1.68% in the intention-to-treat cohort and 1.34% in the per-protocol cohort, Gray said.
At 12 months, the primary outcome (30-day death/stroke/MI plus ipsilateral stroke between day 31 and 12 months) event rate was 2.67% of patients in the intention-to-treat cohort and 2.33% of patients in the per-protocol cohort, he said, noting the rate of that endpoint was lower than observed in any randomized trials of carotid endarterectomy. The rate of target lesion revascularization was 1.47% in both cohorts, and none were clinically driven. No major strokes and no neurological deaths occurred at 12 months.
“In a challenging, high-risk patient cohort, the PERFORMANCE II trial 30-day and 1-year analysis demonstrated durability, safety and effectiveness of the Neurogard Integrated Embolic Protection system,” Gray said during the presentation. “These are the lowest event rates reported for any adequately powered, multicenter trial of any type of carotid revascularization, regardless of patient risk.”
The system is not yet available for commercial use in the United States.
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Gray WA, et al. Late-breaking clinical trials. Presented at: VIVA.23; Oct. 30-Nov. 2, 2023; Las Vegas (hybrid meeting).
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