TY - JOUR
T1 - Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting
AU - Montorsi, Piero
AU - Caputi, Luigi
AU - Galli, Stefano
AU - Ravagnani, Paolo M.
AU - Teruzzi, Giovanni
AU - Annoni, Andrea
AU - Calligaris, Giuseppe
AU - Fabbiocchi, Franco
AU - Trabattoni, Daniela
AU - de Martini, Stefano
AU - Grancini, Luca
AU - Pontone, Gianluca
AU - Andreini, Daniele
AU - Troiano, Sarah
AU - Restelli, Davide
AU - Bartorelli, Antonio L.
N1 - Publisher Copyright:
© 2020 American College of Cardiology Foundation
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/2/24
Y1 - 2020/2/24
N2 - 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)
AB - 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)
KW - double-mesh carotid stent
KW - microembolic signals
KW - proximal protection
KW - transcranial Doppler
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U2 - 10.1016/j.jcin.2019.09.007
DO - 10.1016/j.jcin.2019.09.007
M3 - Article
C2 - 32007460
AN - SCOPUS:85079167686
VL - 13
SP - 403
EP - 414
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 4
ER -