Vascular surgery study of the CGuard MicroNet-covered stent in patients with indication to carotid revascularization: POLGUARD

Abstract

BACKGROUND: In a recent randomized study, MicroNet-covered stent (CGuard) significantly reduced procedural and post-procedural cerebral embolism in relation to a single-layer CREST study carotid stent, but real-life clinical practice data are limited. The aim is to prospectively assess clinical outcomes of CGuard as a routine revascularization tool for patients with indication to carotid revascularization. METHODS: From April 2019 to November 2021, 204 elective patients (age 71.0±7.1years, 69.6% males, 21.7% symptomatic) were enrolled. RESULTS: Mean basal peak-systolic velocity was 251.41±91.85 cm/s with angiographic diameter stenosis 89.7±8.46%. About 34.4% lesions were severely calcified, 6.8% were angulated, and 4.4% showed significant access tortuosity. Access was femoral, with 100% protection device (filter) use. Two hundred and three lesions in 203 patients were treated (1 cross-over to surgery for lack of effective access, no cross-over to other devices); in most cases (66.9%) the stent was placed directly. For pre-dilated lesions, mean balloon diameter was 3.36±0.34mm. Mean nominal stent diameter was 7.64±0.5 mm; length was 37.19±4.5 mm. All stents were post-dilated (balloon diameter 5.2±0.25 mm). Residual stenosis was <30% in all (3.77±6.91%). By discharge, there were 2 minor strokes (0.9%) and one transient ischemic attack. By 30-days, one other minor stroke occurred in relation to de-novo atrial fibrillation. With no deaths or myocardial infarctions, 30-day total death/stroke/myocardial infarction rate was 1.48%. No in-stent thrombosis or patency loss occurred by 30-days. In-stent peak-systolic velocity was 55.49±22.73 cm/s. CONCLUSIONS: Thirty-day results from POLGUARD study indicate safety and a low complication rate of the MicroNet-covered carotid stent use in every-day vascular surgery practice of carotid revascularization. Long-term observation is underway.