William A. Gray MD System Chief of Cardiovascular Services, Main Line Health President, Lankenau Heart Institute Wynnewood, PA USA

Transcription

1 William A. Gray MD System Chief of Cardiovascular Services, President, Wynnewood, PA USA

2 What are the possible causes 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 pharmacology

3 Open and closed cell design elements Closed cell Open cell

4 Stent design: open vs. closed cell

5 Closed cell stent stiffness can lead to kinking

6 Open cell stent can conform to vessel, but may fish-scale

7 Differences in cell size by stent

8 Also need to consider Minimal Circular Unsupported Area (MCUSA)

9 Pore (MCUSA) sizes No significant difference between OC and CC stents N.B. filter pore size ~1/10 th the stent pore size Wallstent Xact Protégé Precise Acculink Xact, PROTÉGÉ RX and Acculink = 8-6mm tapered stents (distal portion) Precise and Wallstent = 8mm straight stent

10 Clinical event rates by free cell area Bosiers M, de Donato G, Deloose K, Verbist J, Peeters P, Castriota F, Cremonesi A, Setacci C. Does free cell area influence the outcome in carotid artery stenting? Eur J Vasc Endovasc Surg Feb;33(2):135-41;

11 European Registry: no effect of stent type on outcomes Symptomatic Patients (n=674) p=0.43 p=0.84 p=0.16 p=0.32 p=0.48 p= % 8% 6% 4% 2% 0% 7.5% 5.8% TIA, stroke& death 3.8% 3.4% stroke& death 6.5% 3.9% TIA, stroke& death 3.1% 1.8% stroke& death 0.7% 1.6% 0.3% 1.3% TIA, stroke& death stroke& death day 0 to 30 day 0 to 30 day 0 day 0 day 1 to 30 day 1 to 30

12 % Death and stroke EXACT (CC) and CAPTURE 2 (OC) No differences in prospective, adjudicated study All Symptomatic Asymptomatic * EXACT (N=2145)* CAPTURE 2 (N=4175) Combined (N=6320) 6.4 EXACT (N=213) CAPTURE 2 (N=548) Combined (N=761) 3.7 EXACT CAPTURE 2 Combined EXACT (N=1931) CAPTURE 2 (N=3627) Combined (N=5558)

13 % of patients Stroke timing paradox: Not all strokes appear on the day of the procedure Procedure Post-Procedure Post-Discharge 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 44% 23% 16% Ipsi (n=139) 18% 14% 4% 0% Non- Ipsi (n=31) Fairman R, Gray W, Scicli A et al. Ann Surg 246 (4) Oct 2007

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15 MRI DWI white matter changes post CAS are greater than CEA: numerically but not by volume

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17 Ideal Pore Size CGUARD *165µ Closed cell stent Open cell stent TERUMO GORE * Average in lesion at expanded state

18 MAL CE Approved Not available for sale in the USA

19 CARENET I

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22 TERUMO: Roadsaver Closed cell structure with flexible Nitinol weave Dual layer micromesh design Retrievable and repositionable

23 CASPER/Roadsaver vs. Closed Cell CAS: OCT Furnished by Dr. M Amor, Polyclinique Louis Pasteur, Nancy, France

24 Regulatory status of CASPER FDA IDE for US investigation is underway, recruiting Lankenau Heart Institute

25 WL Gore SCAFFOLD stent

26 SCAFFOLD: trial description Device Objective Study Design Subjects Principle Investigators Investigational Centers Evaluation Primary Endpoint Gore SCAFFOLD mesh-covered stent Evaluate the performance of the SCAFFOLD stent in treating bifurcation carotid artery stenosis at high risk for CEA Prospective, multicenter, single-arm, open label 312 patients with bifurcation carotid artery stenosis William A. Gray MD (IC) Philadelphia PA Peter Schneider MD (VS) Honolulu HI 30 US sites Baseline, Procedure, 1 month, 1 year, 2 years, 3 years 30-day death, all stroke, myocardial infarction plus ipsilateral stroke to 1 year

27 SCAFFOLD 1 year Primary Endpoints ITT PP 30 Day Endpoint (N) MAE 15 (4.8%) 8 (3.0%) Death 2 (0.6%) 1 (0.4%) Myocardial infarction 4 (1.3%) 4 (1.5%) Q-wave MI 0 (0%) 0 (0%) Stroke 9 (2.9%) 3 (1.1%) Major stroke 5 (1.6%) 3 (1.1%) Ipsilateral 4 (1.3%) 2 (0.8%) Non-ipsilateral 0 (0%) 0 (0%) Hemorrhagic (ipsi) 1 (0.3%) 1 (0.4%) Minor stroke 4 (1.3%) 0 (0%) Ipsilateral 2 (0.6%) Non-ipsilateral 2 (0.6%) 1 Year Endpoint (N) Ipsilateral Stroke (31-365d) 5 (1.7%) 3 (1.2%)

28 Clinically Driven TLR 1-year Target Lesion Revascularization (TLR) ITT 5% 4% 3% 2% 1% 1yr Clinically Driven TLR: 1.4% 1yr Restenosis ( 80%): 1.0% 1yr ECA Patency: 99.6% 0% Time From Procedure (m)

29 One Year Endpoints Compare Favorably to Historical Data Ipsilateral Stroke (31-365d) Clinically Driven TLR (1 Year) SCAFFOLD ITT SCAFFOLD PP ARCHER BEACH 1.7% 1.2% 1.3% 2.5% 1.4% 1.6% 2.2% TLR (1 Year) 4.9% 4.1% 4.7%

30 SCAFFOLD Summary SCAFFOLD trial is the largest multicenter controlled evaluation of mesh-covered CAS The SCAFFOLD trial using the mesh-covered Gore Carotid 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

31 Summary Mesh-covered carotid stents (along with integrated embolic protection/filtration, and direct carotid access with high-flow proximal protection) are likely to add benefit in terms of reducing not only minor stroke events but also surrogate DWI lesions

32 William A. Gray MD System Chief of Cardiovascular Services, President, Wynnewood, PA USA