Results From a Prospective Real-World Multicenter Clinical Practice of CAS Using the CGuard Embolic Prevention System: The IRONGUARD 2 Study

Abstract

Listen

Translate article

To evaluate periprocedural, 30-day, and 12-month outcomes in a prospective series of patients submitted to protected CAS with the CGuard Embolic Prevention System (EPS). From January 2017 to June 2019 a physician-initiated prospective multispecialty, multicenter study was initiated enrolling consecutive patients admitted for protected carotid artery stenting and treated using the CGuard EPS in twelve Italian centers. Primary end points were technical and procedural success, immediate (24 hours) and postprocedural (1-30 days) major and minor stroke, transient ischemic attack (TIA), and death rates. Secondary end points were 12-month neurologic adverse events, acute myocardial infarction (AMI), and external carotid artery occlusion rates. Seven hundred thirty-three patients (73.03 ± 7.84 years of age; 516 male) were enrolled. Mean carotid stenosis was 80.13 ± 8.51% (range, 50%-99%). Symptoms were present in 131 patients (17.87%): 96 TIAs, 23 minor strokes, and 12 major strokes. An embolic protection device was used in 731 (99.72%) cases: distal filter in 593 (80.9%) and proximal occlusion in 138 (18.82%). Procedural success was 100%, technical success was achieved in all but one patient (99.86%). At 24 hours, one patient died due to a hemorrhagic conversion after urgent carotid artery stenting procedure performed for unstable symptoms. Two minor strokes, 6 TIAs, and 1 AMI occurred before hospital discharge. External carotid artery occlusion was evident in eight patients (1.09%). At 30 days, the rate of new averse cardiac and cerebrovascular adverse event was 0.81%: three new neurologic events (2 TIAs, and 1 minor stroke); and three nonfatal AMI. Therefore, up to 30 days, the cumulative rates of death and stroke were 0.13% and 0.54%, respectively. Our analysis suggests that use of the CGuard-EPS in routine clinical practice was associated with an extremely low occurrence of adverse neurologic events in a nonselected patients’ population.