System Chief Of Cardiovascular Services, President .

William A. Gray MDSystem Chief of Cardiovascular Services,Main Line HealthPresident, Lankenau Heart InstituteWynnewood, PAUSA

What are the possiblecauses of stroke in CAS? Operator error Technique (balloon sizing, wire misadventure, EPD error, etc.,) Patient factors Vulnerable plaque (lesion, carotid, aorta) Vascular anatomy or characteristics (calcium, thrombus, etc.,) Genetics related to thienopyridine metabolism Inadequate technology EPD, stent, procedural pharmacologyLankenau Heart InstituteMain Line Health

Open and closed cell design elementsOpen cellClosed cellLankenau Heart InstituteMain Line Health

Stent design: open vs. closed cellLankenau Heart InstituteMain Line Health

Closed cell stent stiffness can lead to kinkingLankenau Heart InstituteMain Line Health

Open cell stent can conform to vessel,but may fish-scaleLankenau Heart InstituteMain Line Health

Differences in cell size by stentLankenau Heart InstituteMain Line Health

Also need to consider Minimal CircularUnsupported Area (MCUSA)Lankenau Heart InstituteMain Line Health

Pore (MCUSA) sizesNo significant difference between OC and CC stentsN.B. filter pore size 1/10th the stent pore iseAcculinkXact, PROTÉGÉ RX and Acculink 8-6mm tapered stents (distal portion)Lankenau Heart InstituteMain Line HealthPrecise and Wallstent 8mm straight stent

Clinical event rates by free cell areaBosiers M, de Donato G, Deloose K, Verbist J, Peeters P, Castriota F, Cremonesi A, Setacci C. Does free cell areainfluence the outcome in carotid artery stenting? Eur J Vasc Endovasc Surg. 2007 Feb;33(2):135-41;Lankenau Heart InstituteMain Line Health

European Registry:no effect of stent type on outcomesSymptomatic Patients (n 674)p 0.43p 0.847.5% 5.8%TIA, stroke&death3.8% 3.4%stroke&deathp 0.16p 0.32p 0.48p 0.2410%8%6%4%2%0%day 0 to 30day 0 to 306.5% 3.9% 3.1% 1.8%TIA, stroke& stroke&deathdeathday 0day 00.7% 1.6% 0.3% 1.3%TIA, stroke& stroke&deathdeathday 1 to 30 day 1 to 30

EXACT (CC) and CAPTURE 2 (OC)No differences in prospective, adjudicated study10EXACT% Death and stroke9CAPTURE XACT (N 2145)*CAPTURE 2 (N 4175)Combined (N 6320)Lankenau Heart InstituteMain Line HealthSymptomaticAsymptomaticEXACT (N 213)CAPTURE 2 (N 548)Combined (N 761)EXACT (N 1931)CAPTURE 2 (N 3627)Combined (N 5558)

Stroke timing paradox:Not all strokes appear on theday of the procedureProcedurePost-ProcedurePost-Discharge% of %14%0%Ipsi (n 139)Non- Ipsi (n 31)Fairman R, Gray W, Scicli A et al. Ann Surg 246 (4) Oct 2007Lankenau Heart InstituteMain Line Health4%

MRI DWI white matter changes post CAS aregreater than CEA: numerically but not by volumeLankenau Heart InstituteMain Line Health

Ideal Pore SizeCGUARD*165µ3755001050Closed cell stent1900Open cell stentTERUMOGORE* Average in lesion at expanded state

CE Approved Not available for sale in the USAMAL-017-14-01Lankenau Heart InstituteMain Line Health

CARENET ILankenau Heart InstituteMain Line Health

TERUMO: Roadsaver– Closed cell structure with flexible Nitinol weave Dual layer micromesh design– Retrievable and repositionableLankenau Heart InstituteMain Line Health

CASPER/Roadsaver vs. Closed Cell CAS: OCTLankenau Heart InstituteMain Line HealthFurnished by Dr. M Amor, Polyclinique Louis Pasteur, Nancy, France

Regulatory status of CASPER FDA IDE for US investigation is underway, recruiting Lankenau HeartInstituteMain Line Health

WL Gore SCAFFOLD stent

SCAFFOLD: trial descriptionDeviceGore SCAFFOLD mesh-covered stentObjectiveEvaluate the performance of the SCAFFOLD stent in treatingbifurcation carotid artery stenosis at high risk for CEAStudy DesignProspective, multicenter, single-arm, open labelSubjects312 patients with bifurcation carotid artery stenosisPrincipleInvestigatorsWilliam A. Gray MD (IC) Philadelphia PAPeter Schneider MD (VS) Honolulu HIInvestigational 30 US sitesCentersEvaluationBaseline, Procedure, 1 month, 1 year, 2 years, 3 yearsPrimaryEndpoint30-day death, all stroke, myocardial infarction plus ipsilateralstroke to 1 year

SCAFFOLD 1 year Primary EndpointsITT31115 (4.8%)8 (3.0%)Death2 (0.6%)1 (0.4%)Myocardial infarction4 (1.3%)4 (1.5%)0 (0%)0 (0%)9 (2.9%)3 (1.1%)Major stroke5 (1.6%)3 (1.1%)Ipsilateral4 (1.3%)2 (0.8%)0 (0%)0 (0%)1 (0.3%)1 (0.4%)Minor stroke4 (1.3%)0 (0%)Ipsilateral2 (0.6%)Non-ipsilateral2 (0.6%)30 Day Endpoint (N)MAEQ-wave MIStrokeNon-ipsilateralHemorrhagic (ipsi)1 Year Endpoint (N)Ipsilateral Stroke (31-365d)PP2642902445 (1.7%)3 (1.2%)

1-year Target Lesion Revascularization(TLR) ITTClinically Driven TLR5%1yr Clinically Driven TLR: 1.4%1yr Restenosis ( 80%): 1.0%1yr ECA Patency: 99.6%4%3%2%1%0%06Time From Procedure (m)12

One Year Endpoints CompareFavorably to Historical DataSCAFFOLDITTSCAFFOLDPPARCHERBEACHIpsilateral Stroke(31-365d)1.7%1.2%1.3%2.5%Clinically DrivenTLR (1 Year)1.4%1.6%2.2%TLR (1 Year)4.9%4.1%4.7%

SCAFFOLD Summary SCAFFOLD trial is the largest multicenter controlledevaluation of mesh-covered CAS The SCAFFOLD trial using the mesh-covered GoreCarotid Stent demonstrated:– 100% technical success– Low 30d stroke rate (1.1%) when used per protocol– Low late stroke rate (1.2%) and clinically driven TLR 1.4%)– Maintenance of ECA

SummaryMesh-covered carotid stents (along withintegrated embolic protection/filtration, anddirect carotid access with high-flow proximalprotection) are likely to add benefit in terms ofreducing not only minor stroke events but alsosurrogate DWI lesionsLankenau Heart InstituteMain Line Health

William A. Gray MDSystem Chief of Cardiovascular Services,Main Line HealthPresident, Lankenau Heart InstituteWynnewood, PAUSA

Xact, PROTÉGÉ RX and Acculink 8-6mm tapered stents (distal portion) Precise and Wallstent 8mm straight stent Pore (MCUSA) sizes Wallstent Xact Protégé Precise Acculink 0.92 0.96 1.08 1.12 1.06 N.B. filter pore size 1/10th the stent pore size