Carotid Artery Stenting

Transcription

1 Carotid Artery Stenting Dusk or Dawn? Ramon L. Varcoe, MBBS, MS, FRACS, PhD Associate Professor of Vascular Surgery University of New South Wales Sydney, Australia

2 Disclosure Speaker name:...ramon L. Varcoe... I have the following potential conflicts of interest to report: Consulting: Medtronic, Abbott Vascular, Boston Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 TRIAL YEAR N Sx DEATH MAJOR CVA SPACE SYMP 0.67 vs 0.86% EVA-3S SYMP 0.8 vs 1.2% P= vs 2.9% 2.7 vs 0.4 Death and Major Stroke Rates are Indistinguishable Between CAS and CEA ICSS (Interim) SYMP 1.4 vs 0.5% P= % vs 1.7% CREST SYMP & ASYMP 0.7 vs 0.3 P= vs 0.6 P=0.52 ACT ASYMP 0.1 vs 0.3 P= vs 0.3 P=1.0

4 TRIAL YEAR N Sx DEATH MAJOR CVA SPACE SYMP 0.67 vs 0.86% EVA-3S SYMP 0.8 vs 1.2% P= vs 2.9% 2.7 vs 0.4 Death and Major Stroke Rates are Indistinguishable Between CAS and CEA ICSS (Interim) SYMP 1.4 vs 0.5% P=0.072 CREST SYMP & ASYMP 0.7 vs 0.3 P= % vs 1.7% 0.9 vs 0.6 P=0.52 Both CAS & CEA are Becoming Safer Over Time ACT ASYMP 0.1 vs 0.3 P= vs 0.3 P=1.0

5 TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA SPACE SYMP 0.67 vs 0.86% 4 vs 2.9% 3.5 vs 3.25% EVA-3S SYMP 0.8 vs 1.2% P=0.68 ICSS (Interim) SYMP 1.4 vs 0.5% P= vs vs 2.3% 1.6% vs 1.7% 4.3% vs 1.2% Minor Stroke is More Common After CAS CREST SYMP & ASYMP 0.7 vs 0.3 P= vs 0.6 P= vs 1.7 P=0.01 Factor 2:1 ACT ASYMP 0.1 vs 0.3 P= vs 0.3 P= vs 1.1 P=0.20

6 TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA AMI SPACE SYMP 0.67 vs 0.86% EVA-3S SYMP 0.8 vs 1.2% P=0.68 ICSS (Interim) SYMP 1.4 vs 0.5% P=0.072 CREST SYMP & ASYMP 0.7 vs 0.3 P= vs 2.9% 3.5 vs 3.25% 2.7 vs vs 2.3% 1.6% vs 1.7% 0.9 vs 0.6 P= % vs 1.2% 3.2 vs 1.7 P=0.01 NR 0.4 vs 0.8% P= vs 0.6% 1.1 vs 2.3 P=0.03 AMI is More Common After CEA Factor 2:1 ACT ASYMP 0.1 vs 0.3 P= vs 0.3 P= vs 1.1 P= vs 0.9% P=0.41

7 TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA AMI CNI ACCESS SITE COMP SPACE SYMP 0.67 vs 0.86% 4 vs 2.9% 3.5 vs 3.25% NR NR NR EVA-3S SYMP 0.8 vs 1.2% P= vs vs 2.3% 0.4 vs 0.8% P= vs vs 1.2 ICSS (Interim) SYMP 1.4 vs 0.5% P= % vs 1.7% 4.3% vs 1.2% 0.3 vs 0.6% 0.1 vs 5.5% 0.9 vs 3.4% CREST SYMP & ASYMP 0.7 vs 0.3 P= vs 0.6 P= vs 1.7 P= vs 2.3 P= vs 4.7% HR= vs 3.5% P= ACT ASYMP 0.1 vs 0.3 P= vs 0.3 P= vs 1.1 P= vs 0.9% P= vs 1.1% P= vs 1.1 P=0.07 Both CNI and Access Site Bleeding are More Common After CEA

8 SURROGATE MARKER FOR CEREBRAL INJURY CAS 40.3% vs CEA12.2% 20 studies; 2104 patients; odds ratio [OR] 5.17; 95% confidence interval [CI], ; p< Gargiulo etal 2015 PLoS ONE 10(5): e doi: /journal.pone

9 So, How Can We Make CAS Safer and REDUCE MINOR STROKE? 1. Patient Selection 2. Better Cerebral Protection 3. Better Stents

10 Macdonald S. Stroke 2009;40:

11 So, How Can We Make CAS Safer and Reduce Minor Stroke? 1. Patient Selection 2. Better Cerebral Protection 3. Better Stents

12 Mo.Ma Device GORE Flow Reversal System

13 Mo.Ma Device

14 Prospective, multi-center, single arm study 225 high-risk patients 15% symptomatic Mean age 74.7; 28.9% >80yo Invatec Mo.Ma device Ansel GM. CCI 2010;76:1-8

15 Any S, AMI & D (30d): 2.7% Symptomatic: 0% Octogenarians: 3.1% Ansel GM. CCI 2010;76:1-8

16 GORE Flow Reversal System Clair DG. CCI 2011;77(3):420-9

17 Prospective, multi-center, single arm study 245 high-risk patients 32% symptomatic Mean age 70; 16% >80yo Gore flow reversal system Clair DG. CCI 2011;77(3):420-9

18 Any S & D: 2.9% Octogenarians: 2.6% Clair DG. CCI 2011;77(3):420-9

19 Meta-Analysis of New Ischemic Lesions on DW-MRI FAVOURS PROXIMAL PROTECTION OVER FILTER Stabile etal JACC: Cardiovascular Interventions Oct 2014, 7 (10) ; DOI: /j.jcin

20 *ICSS Sub-study. Bonati etal 2010 Lancet Neurology 1016:1474

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22 Prospective, single-arm, multi-center ENROUTE TransCarotid neuroprotection system 208 high-risk patients (18 sites) 26% symptomatic Kwolek CJ. JVS 2015;62:

23 S/D/MI (30d) 3.5% Death 1.4% Major CVA 0% Minor CVA 1.4% AMI 0.7% CNI 0.7% No strokes in symptomatic patients or those over 75 Kwolek CJ. JVS 2015;62:

24 Schneider P. LINC 2017

25 So, How Can We Make CAS Safer and Reduce Minor Stroke? 1. Patient Selection 2. Better Cerebral Protection 3. Better Stents

26 CREST Trial Late Strokes after CAS 40% of Stroke occurred after 24 hours! Hill, M.D. et al. CREST Trial Circulation (2012):

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30 What about new generation stents?

31 From Muller-Hulsbeck S. LINC 2016

32 Roadsaver Stent (Terumo)

33 Roadsaver Stent (Terumo) Dual-layer Inner layer nitinol micro-mesh Cell size µm Retrievable & repositionable Self-tapering

34 CLEAR-ROAD Study Multi-center: Belgium, Italy & Germany 100 patients; 31% symptomatic and 69% asymptomatic Roadsaver Stent + EPS used (58%) at the discretion of operators 100% technical success MACCE 30d 1 CVA 1 fatal AMI Bosiers M. Eurointervention 2016;12:e671-e676

35 CGuard Stent (InspireMD) Nitinol SES Polyethylene Terephthalate micronet material Pore size µm

36 CARENET Trial Multi-center: Germany/Poland 30 patients Cguard: Nitinol/PET Protective Stent System + EPS (discretion of the operator) 100% technical success MACCE 30d DW-MRI: 37% had new 48hrs (68% for CAS in ICSS) DW-MRI: 3.8% had new 30d Schofer J. JACC:CI 2015;8(9):

37 GORE Carotid Stent Open cell nitinol SES 500µm PTFE lattice Heparin bonded

38 SCAFFOLD Trial recruiting 50 sites US, Europe, Japan 312 subjects To be released in April at CX

39 CONCLUSION 1. We must address the higher minor stroke rate with CAS 2. Proximal protection and possibly TCAR offer better protection than filters 3. New Mesh-Covered Stents may reduce both procedural and postprocedural Cerebral events

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41 Carotid Artery Stenting Dusk or Dawn? Ramon L. Varcoe, MBBS, MS, FRACS, PhD Associate Professor of Vascular Surgery University of New South Wales Sydney, Australia