The Safety And Effectiveness Of Carotid Revascularization .

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The safety and effectiveness of carotidrevascularization with the Acculink stentand the CGuard stent.Independent randomized studySavr Bugurov, Andrey Karpenko, Pavel IgnatenkoCentre of Vascular and Hybrid SurgeryE.N. Meshalkin National Medical Research Centerof the Ministry of Health

DisclosureSpeaker name:Bugurov SavrI have the following potential conflicts of interest to report:ConsultingEmployment in industryStockholder of a healthcare companyOwner of a healthcare companyOther(s) I do not have any potential conflict of interest

ObjectivesThe main objective of this randomized study was to compare theclinical outcomes and neuroprotection of conventional carotid stentversus the new MicroNet stent CGuard HypothesisThe study hypothesis was a significant reduction of the number ofprocedural and postprocedural new DW-MRI lesions after CAS with the novelCGuard mesh covered stent compared with the Acculink reference stent.

Study design The SIBERIA trial was an Independent Investigator Initiated Study. It was a single center, open label, randomized comparison of twointerventional arms. The study was externally monitored and imaging data wereevaluated by independent core laboratory 100 consecutive patients were enrolled with 1y clinical FU DW-MRI scan at baseline, at 24-48 hour after the procedure, and atthe 30-days follow-up. *The study used the anti-embolic device Emboshield NAV, the pore diameter of the device is equal to the diameter of the cells of theCguard stent (pore size 165 μm)

ENDPOINTSPrimary endpoint:New ischemic brain lesions after the procedure of carotid stentingidentified by MRI within 24-48 hours and 30 days.Secondary endpoints:Technical success, major neurovascular adverse events (death, stroke,myocardial infarction) developed during the procedure and within 30days.

STUDYFLOWCHARTPatients screened for enrollment (n 159)Randomized (n 100)Allocated to Acculink(n 50)baseline MRI performed(n 50)intervention as allocated* (n 50)allocationPost-procedural MRI performed(n 50)Analyzed for primary endpoint(n 50)procedureVital statusMRI FU(n 50)(n 47)&30d follow-upn 46 not meeting inclusion criteria n 13 declined treatment allocation throughrandomizationAllocated to CGuard(n 50)baseline MRI performed(n 50)intervention as allocated* (n 50)Post-procedural MRI performed(n 50)Analyzed for primary endpoint(n 50)Vital statusMRI FU(n 50)(n 49)#* - all CAS with EmboShield NAV6 as per the Centre routine - atrial fibrillation(n 14)- severe renal failure (n 12)- restenotic lesion(n 9)- MRI contraindication (n 11)& 2 patients declined full clinical follow-up due to travel distance, MRI scanner not functional in 1 – the patient declined to visit# 1 MRI scan Corelab-defined inevaluable due multiple artifacts

CLINICAL AND LESION CHARACTERISTICSŁP1ACCULINK n 50CGUARD n 50PAge, years [range]67 [62;72]65 [61;69]0.27Gender, (male) n (%)35 (70 %)38 (76%)0.65Coronary heart disease, n (%)42 (88 %)39 (78 %)0.61Previous coronary revascularization (CABG or PCI), n (%)25 (50 %)22 (32 %)0.69Chronic heart failure, n (%)44 (88 %)45 (90 %)1Diabetes mellitus treatment, n (%)8 (16 %)10 (20 %)0.79Arterial hypertension, n (%)49 (98 %)48 (96 %)1Current smoking, n (%)20 (40 %)17 (34%)0.67Peripheral arterial disease, n (%)17 (34%)15 (30%)0.83Ipsilateral stroke 6m, n (%)6 (12%)11 (22%)0.183 ( 6.0 %)5 (10 %)0.46Contralateral carotid artery stenosis 50%; n (%)9 (18%)18 (36%)0.75Contralateral carotid artery occlusion; n (%)3 (6.0%)8 (16%)0.11Degree of stenosis (QCA, % [range])76 [67;88]75 [72;89]0.72Affected side right, n (%)27 (54 %)30 (60%)0.77Ipsilateral TIA 6m, n (%)

RESULTSDW-MRI embolism at 48h(raw data, external CoreLab, blinded analysis)p 0.003SMALLER lesionsFEWER lesions

RESULTSDW-MRI embolism at 48h(external CoreLab, blinded analysis)TOTAL LESION VOLUMEper-patientPRIMARY ENDPOINT57% reductionin lesion(per-patient)averagevolume4.5-foldreduction intotal volumeof periprocedurallesions(per-patient)(bars are 95%CI)

RESULTSMRI and Clinical outcomes at 30 daysPERSISTENT Cerebral Lesions(FLAIR)CGuard arm: No new DW-MRI lesions at 30 daysNumberAcculink6CGuard0p 0.030p 0.001CGuard arm: No MACNE at 30 daysStrokeMyocardial InfarctionAcculink21NB. Data are for ipsilateral lesions as per the study protocol main endpointCGuard00

CLINICAL OUTCOMES after 1 yearACCULINK n 50CGUARD n 50PRestenosis2 (4%)0 (0%)0.49Vessel occlusion1 (2%)0 (0%)1Deaths2 (4%)1 (2%)110 (20%)1 (2%)0.2TOTAL MACE

CONCLUSIONIn a randomized, controlled, externallymonitored clinical trial with independentdata analysis,MicroNET-covered carotid stent – inrelation to a classic (single-layer) carotidstent: reduced 4.5-fold the magnitude ofperi-procedural silent brain infarctsvolume abolished post-procedural silentinfarcts that, in contrast, were on-goingwith the classic stentThese findings may impact decisionmaking in carotid revascularization forprimary and secondary stroke prevention,including stent type selection

The study used the anti-embolic device Emboshield NAV, the pore diameter of the device is equal to the diameter of the cells of the Cguard stent (pore size 165 μm) ENDPOINTS Primary endpoint: New ischemic brain lesions after the procedure of carotid stenting identified by

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