Carotid artery stenting (CAS) performed with the double-layer Roadsaver stent and proximal protection using the Mo.Ma Ultra device was found to be associated with the best outcomes, in terms of microembolic signals (MES), in high-risk patients with lipid-rich plaques, according to a study published in JACC: Cardiovascular Interventions.
The rate of minor stroke is higher following CAS vs carotid endarterectomy. This complication may be related to the types of c and cerebral protection (ie, distal vs proximal) used during the procedure.
Between February 2016 and January 2018, a total of 104 consecutive stenotic patients were prospectively enrolled (ClinicalTrials.gov identifier: NCT02915328) between February 2016 and January 2018. Participants were randomly assigned to undergo CAS with a Filterwire device for distal embolic protection and a Roadsaver stent (n=27; mean age, 72.4 years; 74% men), a Filterwire device and a Carotid Wallstent (n=25; mean age, 73.4 years; 92% men), a Mo.Ma Ultra device for proximal embolic protection and a Roadsaver stent (n=27; mean age, 70 years; 92% men), or a Mo.Ma device and a Carotid Wallstent (n=25; mean age, 72 years; 84% men).
The study’s primary outcome was the MES count assessed using transcranial Doppler during the first and second (target vessel access), third (lesion wiring), fourth (predilation), fifth (stent crossing), sixth (stent deployment), seventh (stent dilation), and eighth (device retrieval/deflation) steps of the CAS procedure. Secondary outcomes were the rates of in-hospital and 30-day major adverse cardiovascular and cerebrovascular events (MACCES), in-stent restenosis rates, and target vessel patency.
Patients in all 4 treatment groups had comparable baseline characteristics. CAS performed with a Mo.Ma vs Filterwire device was associated with a reduction in MES count during steps 3, 5, 6, and 7 (P <.0001 for all); step 8 (P =.038); and steps 6, 7, and 8 combined (in the presence or absence of spontaneous MES, P <.0001 for both). Use of the Roadsaver stent was associated with fewer MES during steps 6 through 8 in the absence or presence of spontaneous MES (occurring in 29% of patients), compared with use of the Carotid Wallstent (P =.032 and P =.016, respectively). CAS procedures performed with the Mo.Ma device and Roadsaver stent vs with the Mo.Ma device and Carotid Wallstent were associated with fewer MES counts (P =.043). Proximal embolic protection was found to account for 70% to 80% of the reduction in total MES count, making it the best-performing device/stent combination. No macroemboli were observed at any time.
There was a significant reduction in peak systolic velocity after CAS in all patients, and stent patency persisted in all groups. Clinical MACCES were reported in 3 participants (3.8%). At 6 months, in-stent restenosis had developed in 1 of 94 individuals (0.98%). The only independent predictor of external carotid artery patency was use of the Roadsaver stent, which had a negative impact on patency compared with the Carotid Wallstent, 1 and 30 days after the procedure (P =.035 and P =.0039, respectively).
Study limitations include the fact that the use of other types of distal filters or double-layer stents was not examined and that a small sample size did not allow assessment of clinical outcomes.
“Given the high rate of MACCES occurring in the post-procedural phase when brain protection is no longer in place, the favorable [double layer stent] effect should be investigated at that time and correlated with the rate of plaque prolapse detected by imaging techniques at the end of CAS,” noted the authors.
Montorsi P, Caputi L, Galli S, et al. Carotid wallstent versus roadsaver stent and distal versus proximal protection on cerebral microembolization during carotid artery stenting. JACC Cardiovasc Interv. January 2020. doi:10.1016/j.jcin.2019.09.007