Carotid stenting is equivalent to carotid endarterectomy in terms of major adverse events (death, AMI, and stroke). However, it entails higher risk of minor stroke due to micro-particle embolization, when conventional thromboembolic protection devices won’t capture them.
Neuroguard IEP System integrates a 40-micron distal thromboembolic filter, a post-dilation balloon, and a stent, reducing catheter exchange and improving thromboembolic protection.
The PERFORMANCE II was a prospective, multicenter, single arm study including 305 patients with significant carotid stenosis and high risk of carotid endarterectomy.
Primary end point was a composite of death, any stroke or myocardial infarction within 30 days.
Patients mean age was 69.6 ± 7.5 years, 65.9% were men, and 20% were symptomatic. Hypertension prevalence was 93%, and diabetes 43%. Main risk factors included hypertension, stroke or TIA in 21% of cases, and a history of endarterectomy in 10%.
25% of patients presented high risk anatomy for this procedure and nearly half had significant comorbidities. The right carotid was the most treated artery (51%), with post endarterectomy 7% restenosis rate and severe calcification in 34% of cases.
Read also: Is Angioplasty Always Necessary after TAVR?
Primary end point was seen in 2.3% of cases, with 0.3% mortality, 1.3% stroke and 0.7% MI. At 12 months there were no neurological deaths, stroke or major stent thrombosis. Target lesion revascularization (TLR) rate was 1.1%, and incidence of any stroke 1.8%.
A subgroup analysis revealed that asymptomatic patients had a stroke/death rate of 1.2% at 30 days, vs symptomatic patients (p=0.175). stroke rate at 30 days was similar between patients under 70 or more (1.8%; p=0.633), with no significant differences in sex. (p=1.000).
Conclusion
Major adverse events rate resulted extremely low, showing its safety, efficacy and durability in high risk patients.
Original Title: A Prospective Multicenter Investigation of a Novel Carotid Stent System: The PERFORMANCE II Trial.
Reference: William A. Gray et al. JACC: Cardiovascular Interventions, Volumen 18, 367–376, 2025.
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