Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting

Objectives: The aim of this study was to randomly compare the double-layer Roadsaver stent (RS) (Terumo, Tokyo, Japan) with the single-layer Carotid Wallstent (CW) (Boston Scientific, Santa Clara, California) in association with either distal embolic protection with the FilterWire (FW) device (Boston Scientific) or proximal protection with the Mo.Ma Ultra device (Medtronic, Santa Rosa, California) in patients with lipid-rich carotid plaques. Background: The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled. Methods: A total of 104 consecutive patients with carotid artery stenosis were randomized to CAS with FW + RS (group 1, n = 27), FW + CW (group 2, n = 25), Mo.Ma + RS (group 3, n = 27), or Mo.Ma + CW (group 4, n = 25). The primary endpoint was the number of microembolic signals (MES) on transcranial Doppler among groups in the following CAS steps: 1 and 2) target vessel access; 3) lesion wiring; 4) pre-dilation; 5) stent crossing; 6) stent deployment; 7) stent dilation; and 8) device retrieval and deflation. Results: No significant differences in baseline characteristics were found among the 4 groups. Compared with the FW device, the Mo.Ma Ultra device significantly reduced mean MES count (p < 0.0001) during lesion crossing, stent crossing, stent deployment, and post-dilation. Compared with the CW, the RS significantly reduced MES count (p = 0.016) in steps 6 to 8, including spontaneous MES (29% of patients). The combination of Mo.Ma + RS performed significantly better than Mo.Ma + CW (p = 0.043). Clinical major adverse cardiac and cerebrovascular events occurred in 3 patients (p = 0.51). After CAS, peak systolic velocity significantly decreased in all patients. In-stent restenosis developed in 1 patient (0.98%) at 6-month follow-up. The RS was an independent predictor of external carotid artery patency over time. Conclusions: In patients with high-risk, lipid-rich plaque undergoing CAS, Mo.Ma + RS led to the lowest microembolic signals count. (Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection; NCT02915328)