Endovascular vs Surgical Carotid Revascularisation

Endovascular vs Surgical Carotid Revascularisation Lessons Learned from Clinical Trials and How I Approach it in My Practice Ramon L. Varcoe, MBBS, MS, FRACS, PhD Associate Professor of Vascular Surgery University of New South Wales Sydney, Australia

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

Randomized Controlled Trials

TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA AMI CNI ACCESS SITE COMP SPACE 2006 1200 SYMP 0.67 vs 0.86% 4 vs 2.9% 3.5 vs 3.25% NR NR NR EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 2.7 vs 0.4 6.1 vs 2.3% 0.4 vs 0.8% P=0.62 1.1 vs 7.7 3.1 vs 1.2 ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 1.6% vs 1.7% 4.3% vs 1.2% 0.3 vs 0.6% 0.1 vs 5.5% 0.9 vs 3.4% CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 0.9 vs 0.6 P=0.52 3.2 vs 1.7 P=0.01 1.1 vs 2.3 P=0.03 0.3 vs 4.7% HR=0. 07 1.1 vs 3.5% P=0.00 01 ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0 2.4 vs 1.1 P=0.20 0.5 vs 0.9% P=0.41 0.1 vs 1.1% P=0.02 0.3 vs 1.1 P=0.07

Mrs Brown 77-year-old female BG: IHD (previous PCI 2010), HTN, Dyslipidaemia, GORD Reformed smoker, 36 months, previously heavy MEDS: Coversyl plus, Crestor, Aspirin, Nexium Lives independently alone with family supports nearby

Mrs Brown TIA: Right arm weakness 48 hours ago Now resolved First event

Mrs Brown TIA: Right arm weakness 48 hours ago Now resolved First event

TRIAL YEAR N Sx DEATH MAJOR CVA SPACE 2006 1200 SYMP 0.67 vs 0.86% EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 4 vs 2.9% 2.7 vs 0.4 Death and Major Stroke Rates are Indistinguishable Between CAS and CEA ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 1.6% vs 1.7% CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 0.9 vs 0.6 P=0.52 ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0

TRIAL YEAR N Sx DEATH MAJOR CVA SPACE 2006 1200 SYMP 0.67 vs 0.86% EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 4 vs 2.9% 2.7 vs 0.4 Death and Major Stroke Rates are Indistinguishable Between CAS and CEA ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 1.6% vs 1.7% 0.9 vs 0.6 P=0.52 Both CAS & CEA are Becoming Safer Over Time ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0

TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA SPACE 2006 1200 SYMP 0.67 vs 0.86% 4 vs 2.9% 3.5 vs 3.25% EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 2.7 vs 0.4 6.1 vs 2.3% 1.6% vs 1.7% 4.3% vs 1.2% Minor Stroke is More Common After CAS CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 0.9 vs 0.6 P=0.52 3.2 vs 1.7 P=0.01 Factor 2:1 ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0 2.4 vs 1.1 P=0.20

TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA AMI SPACE 2006 1200 SYMP 0.67 vs 0.86% EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 4 vs 2.9% 3.5 vs 3.25% 2.7 vs 0.4 6.1 vs 2.3% 1.6% vs 1.7% 0.9 vs 0.6 P=0.52 4.3% vs 1.2% 3.2 vs 1.7 P=0.01 NR 0.4 vs 0.8% P=0.62 0.3 vs 0.6% 1.1 vs 2.3 P=0.03 AMI is More Common After CEA Factor 2:1 ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0 2.4 vs 1.1 P=0.20 0.5 vs 0.9% P=0.41

TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA AMI CNI ACCESS SITE COMP SPACE 2006 1200 SYMP 0.67 vs 0.86% 4 vs 2.9% 3.5 vs 3.25% NR NR NR EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 2.7 vs 0.4 6.1 vs 2.3% 0.4 vs 0.8% P=0.62 1.1 vs 7.7 3.1 vs 1.2 ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 1.6% vs 1.7% 4.3% vs 1.2% 0.3 vs 0.6% 0.1 vs 5.5% 0.9 vs 3.4% CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 0.9 vs 0.6 P=0.52 3.2 vs 1.7 P=0.01 1.1 vs 2.3 P=0.03 0.3 vs 4.7% HR=0. 07 1.1 vs 3.5% P=0.00 01 ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0 2.4 vs 1.1 P=0.20 0.5 vs 0.9% P=0.41 0.1 vs 1.1% P=0.02 0.3 vs 1.1 P=0.07 Both CNI and Access Site Bleeding are More Common After CEA

Silver FL. Stroke 2011;42:675-680

Gender: CREST Howard VJ. Lancet Neurol 2011;10(6):530-7

!! CREST Howard VJ. Lancet Neurol 2011;10(6):530-7

4754 patients Meta-Analysis CEA vs CAS Howard G. et al Lancet 2016;387:1305-1311

Age: Hazard Ratio CAS vs CEA Any S & D Ipsi S only Howard G. et al Lancet 2016;387:1305-1311

Age Stratum CAS vs CEA CEA Howard G. et al Lancet 2016;387:1305-1311

Age Stratum CAS vs CEA CEA CAS >70 yo do worse with CAS Howard G. et al Lancet 2016;387:1305-1311

Age Stratum CAS vs CEA CEA CAS >70 yo do worse with CAS Those <65 yo do better with CAS! Howard G. et al Lancet 2016;387:1305-1311

Mrs Brown 77-year-old female BG: IHD (previous PCI 2010), HTN, Dyslipidaemia, GORD Looking for features that may make CEA higher risk

Mr Brown 52-year-old male BG: IHD (previous PCI 2010), HTN, Dyslipidaemia, GORD Looking for features that may make CAS higher risk

Macdonald S. Stroke 2009;40:1698-1703

Macdonald S. Stroke 2009;40:1698-1703

2502 patients 1578/2502 (63%) angiograms available 438/1240 (35%) CEA had angiogram 1141/1262 (90%) CAS had angiogram available Moore WS. JVS 2016;63:851-8

Sequential or Remote Lesions 2 1 Moore WS. JVS 2016;63:851-8

Moore WS. JVS 2016;63:851-8

Long Lesions Moore WS. JVS 2016;63:851-8

Moore WS. JVS 2016;63:851-8

Comorbidities Cardiac Angina (CCS class 3-4 or unstable) CCF (class 3-4) LVEF <35% AMI <6 weeks CAD 2 major vessels Respiratory Severe COPD Home oxygen Resting po2 < 60 Resting FEV < 50% Neuro Permanent contralateral CN injury

Anatomical Considerations High Carotid Above the angle of jaw Angle of the jaw

Anatomical Considerations Hostile Neck Radiation Previous Surgery Bull neck

Anatomical Considerations Contralateral Carotid Occlusion

I ve been reading doc would it be worse for me to have a minor stroke or a heart attack?

TRIAL YEAR N Sx DEATH MAJOR CVA MINOR CVA AMI SPACE 2006 1200 SYMP 0.67 vs 0.86% EVA-3S 2006 527 SYMP 0.8 vs 1.2% P=0.68 ICSS (Interim) 2010 1713 SYMP 1.4 vs 0.5% P=0.072 CREST 2010 2505 SYMP & ASYMP 0.7 vs 0.3 P=0.18 4 vs 2.9% 3.5 vs 3.25% 2.7 vs 0.4 6.1 vs 2.3% 1.6% vs 1.7% 0.9 vs 0.6 P=0.52 4.3% vs 1.2% 3.2 vs 1.7 P=0.01 NR 0.4 vs 0.8% P=0.62 0.3 vs 0.6% 1.1 vs 2.3 P=0.03 AMI and minor CVA are each favoured by the opposite Rx Factor 2:1 ACT-1 2016 1453 ASYMP 0.1 vs 0.3 P=0.43 0.5 vs 0.3 P=1.0 2.4 vs 1.1 P=0.20 0.5 vs 0.9% P=0.41

CREST-Gray WA. Circ 2012;125(18):2256-64

CREST-Gray WA. Circ 2012;125(18):2256-64

Is this all about risk of stroke and heart attack? Or are there other possible complications as well?

CREST: CNI CREST-Gray WA. Circ 2012;125(18):2256-64

Are there any differences In local wound or access complications???

CREST-Gray WA. Circ 2012;125(18):2256-64

Once I ve had treatment Is it likely that the narrowing will come back and give me a stroke In the future?

CREST: Restenosis Restenosis or revascularisation occurred in 12.2% CAS vs 9.7% of CEA (HR, 1.24; 95% CI, 0.91-1.70) Brott TG. NEJM 2016;374:1021-31

CREST: Composite Endpoint The 10-yr risk of the primary composite of any stroke, MI or death did not differ significantly (HR, 1.10; 95% CI, 0.83-1.44; P=0.51) Brott TG. NEJM 2016;374:1021-31

CONCLUSION 1. Both CEA and CAS are safe and improving 2. Both procedure are equally durable in stroke prevention 3. Best outcomes may be achieved by matching your individual patient, anatomy and lesion characteristics to the Rx

Endovascular vs Surgical Carotid Revascularisation Lessons Learned from Clinical Trials and How I Approach it in My Practice Ramon L. Varcoe, MBBS, MS, FRACS, PhD Associate Professor of Vascular Surgery University of New South Wales Sydney, Australia