Endovascular vs Surgical Carotid Revascularisation
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1 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
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 Randomized Controlled Trials
4 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
5 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
6 Mrs Brown TIA: Right arm weakness 48 hours ago Now resolved First event
7 Mrs Brown TIA: Right arm weakness 48 hours ago Now resolved First event
8 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
9 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
10 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
11 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
12 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
13
14
15 Silver FL. Stroke 2011;42:
16
17
18 Gender: CREST Howard VJ. Lancet Neurol 2011;10(6):530-7
19 !! CREST Howard VJ. Lancet Neurol 2011;10(6):530-7
20
21 4754 patients Meta-Analysis CEA vs CAS Howard G. et al Lancet 2016;387:
22 Age: Hazard Ratio CAS vs CEA Any S & D Ipsi S only Howard G. et al Lancet 2016;387:
23 Age Stratum CAS vs CEA CEA Howard G. et al Lancet 2016;387:
24 Age Stratum CAS vs CEA CEA CAS >70 yo do worse with CAS Howard G. et al Lancet 2016;387:
25 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:
26 Mrs Brown 77-year-old female BG: IHD (previous PCI 2010), HTN, Dyslipidaemia, GORD Looking for features that may make CEA higher risk
27 Mr Brown 52-year-old male BG: IHD (previous PCI 2010), HTN, Dyslipidaemia, GORD Looking for features that may make CAS higher risk
28
29 Macdonald S. Stroke 2009;40:
30 Macdonald S. Stroke 2009;40:
31 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
32 Sequential or Remote Lesions 2 1 Moore WS. JVS 2016;63:851-8
33 Moore WS. JVS 2016;63:851-8
34 Long Lesions Moore WS. JVS 2016;63:851-8
35 Moore WS. JVS 2016;63:851-8
36
37 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
38 Anatomical Considerations High Carotid Above the angle of jaw Angle of the jaw
39 Anatomical Considerations Hostile Neck Radiation Previous Surgery Bull neck
40 Anatomical Considerations Contralateral Carotid Occlusion
41 I ve been reading doc would it be worse for me to have a minor stroke or a heart attack?
42 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 and minor CVA are each favoured by the opposite Rx 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
43 CREST-Gray WA. Circ 2012;125(18):
44 CREST-Gray WA. Circ 2012;125(18):
45 Is this all about risk of stroke and heart attack? Or are there other possible complications as well?
46 CREST: CNI CREST-Gray WA. Circ 2012;125(18):
47 Are there any differences In local wound or access complications???
48 CREST-Gray WA. Circ 2012;125(18):
49 Once I ve had treatment Is it likely that the narrowing will come back and give me a stroke In the future?
50 CREST: Restenosis Restenosis or revascularisation occurred in 12.2% CAS vs 9.7% of CEA (HR, 1.24; 95% CI, ) Brott TG. NEJM 2016;374:
51 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, ; P=0.51) Brott TG. NEJM 2016;374:
52 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
53
54 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
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