Carotid Artery Disease and Carotid StentingAsymptomatic Carotid Artery Stenosis • SMART Study –...

Carotid Artery Disease and Carotid Stenting

University of Maryland School of Medicine

Khanjan H. Nagarsheth MD, MBA, FACS, RPVIAssistant Professor of Surgery

Medical Director of Imaging Core LabMedical Director of Office Based LabCo-Director Limb Preservation Clinic

Medical Director Vascular Surgery Progressive Care UnitAssociate Program Director, Vascular Surgery Fellowship

Division of Vascular SurgeryUniversity of Maryland School of Medicine

Baltimore, MD

Disclosures• No financial disclosures relevant to this

presentation

The Press

Rabin RC, New York Times, 2/26/2010

Risk of Stroke in Asymptomatic Patients

Chambers et al. NEJM. 315(14):860-5, 1986.Norris et al. Stroke. 22(12):1485-90, 1991.

Which Modality is Superior?Endarterectomy?

Stenting?

Best Medical Therapy?

Medical Therapy• Modulators of the Renin Angiotensin System**

– Ace Inhibitors– Angiotensin Receptor Blockers

• HMG CoA Reductase Inhibitors**

• New antiplatelet therapies**

**These therapies did not exist during the pivotal carotid revascularization trials

The PROGRESS Trial

PROGRESS Collaborative Group. Lancet. 358(9287):1033-41, 2001.

The SPARCL Trial

Amarenco P et al. NEJM. 355(6):549-59, 2006.

Asymptomatic Carotid Artery Stenosis• SMART Study

– 221 patients with followed for 5 years

• Oxford Vascular Study

– 101 patients followed for 3 years

• <0.5% stroke risk per year in patients with >50% carotid artery stenosis

Goessens BM et al. J Vasc Surg. 43(3):525-32, 2006.Marquardt L et al. Stroke. 41(1):e11-7, 2010.

Asymptomatic Moderate to Severe Stenosis

• Overall annual risk of stroke ~0.5 - 1% with medical management

• Carotid duplex US q 6 month at first, then annually if stable

• If stenosis worsens despite maximum medical management, consider revascularization

• Lifestyle modification (quit smoking, eat better, exercise)

• Antiplatelet monotherapy preferred to combination

• Target LDL <70

• Unilateral asymptomatic stenosis (>70%) BP goal <140/90

Medical Management Prevention of Disease Progression

Conrad MF et al. J Vasc Surg. 60(5):1218-25, 2014.

Carotid Endartectomy• The model of evidenced based medicine in surgery

• Most common procedure performed by vascular surgeons in this country

• Long term benefits and stroke from survival

• The standard against which we measure everything else for carotid disease

Adoption of New Technologies

20122015

1989

2006

Disruptive Technology

Outcomes of Carotid Revascularization Trials

Asymptomatic

Symptomatic

Carotid Stents

Carotid Stent Approval• FDA

– Asymptomatic >80% stenosis, high risk for CEA– Symptomatic >50% stenosis, high risk for CEA

• CMS

– Symptomatic >70% stenosis, high risk for CEA– Must use embolic protection device– Must use single stent– Must be Rankin 0-3– Must be certified by CMS as a qualified center and all cases must be

entered into the CMS database

SAPPHIRE Trial• 723 patient enrolled• >50% ICA stenosis with symptoms• >80% ICA stenosis with no symptoms• > 1 comorbid condition

• Randomized – Stenting with embolic protection – 159 patients– CEA – 151 patients

• Enrolled into registry– Refused surgery – 409 patients– Refused stent – 7 patients

• Primary endpoint – 30 day stroke, death, MI

Yadav et al. NEJM. 351(15):1493-501, 2004.

SAPPHIRE Trial• Outcomes for stents:

– Death 0.6%– Major Stroke 0.6%– Minor Stroke 3.2%– MI 2.6%– Combined endpoint 5.8%

• Outcomes for CEA– Death 2%– Major Stroke 2%– Minor Stroke 3.3%– MI 7.3%– Combined endpoint 12.6%

Yadav et al. NEJM. 351(15):1493-501, 2004.

SAPPHIRE Trial• No difference in occurrence of major adverse

event at 3 years

• No difference in death at 3 years

• No difference in ipsilateral stroke at 3 years

• No difference in need for reintervention

Yadav et al. NEJM. 351(15):1493-501, 2004.

Event Rates of Carotid Stenting Trials

EVA-3S Trial• Stent-protected angioplasty v. CEA in symptomatic patients

with >60% ICA stenosis

• 872 patients needed for non-inferiority• 527 patients enrolled – trial stopped for safety and futility

reasons

• Primary endpoint – 30-day stroke/death– CEA 3.9% v. CAS 9.6%– 6 month stroke/death – CEA 6.1% v. CAS 11.7%

• 17% of patients did not get loaded with Plavix prior to CAS

Mas et al. NEJM. 355;1660:2006.

EVA-3S Revisited• Follow up revealed no difference in stroke

rates between CEA and CAS at 4 years

PROTECT Trial• 30-day major adverse events in high risk patients

– Death 0.5%

– Stroke 0.5%

– MI 0.4%

– Combined endpoint 2.3%

– Annulaized ipsilateral stroke rate of 0.4% following CAS

Matsumura JS, et al. J Vasc Surg. 55(4);968-976, 2012.

CREST• Prospective, multicenter, randomized, controlled trial

with blinded endpoint adjudication

• CAS v. CEA in 2300 patients with symptomatic and asymptomatic stenosis

• 117 total sites between USA and Canada

• Only 52% of applicants were selected as CAS operators due to a rigorous credentialing process

CREST

Carotid Stent Endarterectomy p-Value

Periop Stroke 4.1% 2.3% 0.01

MI 1.1% 2.3% 0.03

Stroke/Death/MI 5.2% 4.5% 0.38

Major Stroke 0.9% 0.6% 0.52

Cranial nerve injury 0.3% 4.7% <0.01

CREST• No difference for primary endpoint at follow

up

CREST• Long term mortality was correlated more

strongly with MI

Gray et al. Circulation 2012…

CREST• Neither age nor presence of symptoms

affected primary EP


CREST


CREST• Cranial nerve injuries examined


CREST• Critics of the study align with either CEA or CAS

• Those in favor of CEA claim:– Strokes are more likely with CAS than CEA and patients care more

about stroke than MI– Most MI were minor (troponin spill)– Most cranial nerve injuries resolved

• Those in favor of CAS claim:– CAS technology in CREST is now considered outdated– Early learning curve for CAS makes it accessible by most operators– Cranial nerve injury and MI are very morbid for patients

Largest Trials for CAS v. CEA

Trial 30-Day Outcome for Stroke and MICEA CAS p-Value

EVA-3S 3.9% 9.6% 0.01

SPACE 6.3% 6.8% 0.09

ICSS 4.7% 8.5% 0.001

CREST (symptomatic) 5.4% 6.7% 0.30

CEA versus CAS in Symptomatic Patients

• CAS and CEA are equivalent in primary endpoint and long-term stroke prevention in CREST

• Large, controlled single arm studies of high risk patientsAHA guideline standard recommendation

– EU trials were flawed in design

– Significant improvement in devices, technology and distal protection during the course of studies

– More wound complications and cranial nerve injury with CEA

CEA versus CAS in Asymptomatic Patients

• Asymptomatic carotid stenosis is a risk factor for stroke• Surgical revascularization is proven beneficial v. unmonitored

medical therapy

• CAS outcomes have equivalent outcomes to CEA (CREST), achieved AHA guidelines and have a Class IIb recommendation in asymptomatic patients– CEA is Class Iia

• The available randomized controlled data supports revascularization in suitable patients with high grade asymptomatic stenosis– Medical therapy is attractive but not proven head to head

Extra-cranial Vascular Disease Guidelines

Stroke, 2011;42:e464-e540.

Classification of Recommendations

Recommendations Based on ECVD Guidelines

Symptomatic Symptomatic Asymptomatic

50-69% stenosis 70-99% stenosis 70-99% stenosis

CEA Class I Level B Class I Level A Class IIa Level A

CAS Class I Level B Class I Level B Class IIb Level B

Cost Comparison CEA v. CAS

The Plot Thickens

International Carotid Stenting Study

• 1710 patients enrolled, all who were recently symptomatic with stroke or TIA

• Primary goal was to determine long term survival, free of disabling stroke

• Had 3-year follow up data

Lancet February 2010

International Carotid Stenting Study

CREST 2• Carotid revascularization and medical

management for asymptomatic carotid disease

• Parallel study design with 1240 patients in each trial

Definition• Criteria for > 70% ICA stenosis

– PSV >230 cm/sec plus one of the following criteria

– EDV > 100 cm/sec

– ICA/CCA > 4

– > 70% stenosis on MRA

– >70% stenosis on CTA

Interventionalist Eligibility• Must have done at least 50 total procedures

• If <50, then must have done at least 8 in last 2 years

• Each operator must have been reviewed and approved by the CREST-2 IMC

Which Trial Should Patients Be Put In?• Based on CREST

– Patients 50-74 years old had equivalent outcomes– Patients <50 years old did better with CAS– Patient >74 years old did better with CEA

• But in CREST asymptomatic patients had few events and very wide confidence intervals

– Therefore the choice of procedure cannot be mandated in CREST 2

CREST-2 Exclusions• Excessive or circumferential calcification of the stenotic lesion

• Lesion >20mm length, sequential lesions

• Inability to use embolic protection devices

• Excludes octogenarians

• Excludes high risk for CAS– Advanced age– Recent symptoms– Challenging anatomy

TCAR• Trans carotid artery revascularization

Periprocedural Stroke Rates Presentations & Publications of TCAR & CEA

1.3% 1.4% 1.1% 1.0%1.4% 1.2%

2.3%

3.6%

PROOF ROADSTER

UnivRochester& StonyBrook

UH,Cleveland

Multi-Center

VQI - TCARSurveillanc

eVQI - CEA CREST

SSRSVS HSR

REGISTRY

Stroke 1.3% 1.4% 1.1% 1.0% 1.4% 1.2% 2.3% 3.6%

High Surgical Risk Patients

PROOF: J Endovasc Ther. 2017 Apr;24(2):265-270ROADSTER: J Vasc Surg. 2015 Nov;62(5):1227-34. The Silk Road System for Transcervical Access with Reversal of Flow to Perform TCAR: Results of the ROADSTER Trial - VEITH, 2016Univ Rochester & Stony Brook: Transcarotid Arterial Revascularization: First Post-Approval Safety & Efficacy Study – VAM, 2018 Poster PresentationUH Cleveland: A Multi Institutional Analysis of TCAR Compared to CEA – VAM, 2018 Poster PresentationVQI TCAR + CEA: In-Hospital Outcomes of TCAR & CEA in the SVS-VQI TCAR Surveillance Project – VEITH Symposium 2018 Presentation Unadjusted Outcomes – M. Schermerhorn, MDCREST Standard Surgical Risk: N Engl J Med. 2016 Mar 17;374(11):1011-20.SVS Registry: J Vasc Surg. 2013 May;57(5):1318-24.

n=219 n=2,545n=75

TCAR

n=1,240n=292n=88

CEA

n=43,114

P=.27

n=6,370

In-Hospital Outcomes of TCAR and CEA in the SVS-VQI TCAR Surveillance ProjectMarc Schermerhorn, MD; Patric Liang, MD; Hanaa Dakour Aridi, MD; Vikram Kashyap, MD; Grace Wang, MD; Brian Nolan, MD; Jack Cronenwett, MD; Jens Eldrup-Jorgensen, MD; Mahmoud Malas, MD, MHS – VEITH Symposium Presentation, November 2018

Baseline Characteristics TCAR N=2,545

CEAN=43,114 P-value

Age, Mean (SD) 73.1 + 9.4 70.6 + 9.6 <.001

Female 36% 39% <.01

Black 5% 5% .61

Hypertension 90% 89% .50

Diabetes Mellitus 37% 36% .52

Coronary Artery Disease 51% 27% <.001

CHF 19% 11% <.001

COPD 29% 23% <.001

Chronic Kidney Disease (GFR <60) 41% 34% <.001

Prior CEA/CAS 31% 15% <.001

Asymptomatic 53% 51% .37

General Anesthesia 83% 92% <.001

Unadjusted Outcomes TCARN = 2,545

CEAN = 43,114 P-value

Stroke/Death 1.8% 1.4% .09

Stroke/Death/MI 2.1% 1.8% .17

Stroke 1.4% 1.2% .27

In-hospital Death 0.5% 0.3% .04

30-day Death 0.9% 0.6% .08

Myocardial Infarction 0.4% 0.4% .71

Hemodynamic Instability

Hypertension 12% 20% <.001

Hypotension 13% 10% <.001

Bleeding with Intervention 1.4% 1.0% .05

Reperfusion Syndrome 0.2% 0.2% .54

CNI 0.2% 2.7% <.001

Operative Time, Mins, Mean 75 + 31 116 + 45 <.001

LOS, Days, Median (IQR) 1 (1-2) 1 (1-2) .34

LOS >1 day 29% 32% <.01

TCAR - TransCarotid Artery Revascularization First Post-Approval Safety and Efficacy Study (2 Center Analysis) - VAM, June 2018Mark D. Balceniuk, MD1, Michael C. Stoner, MD1, Brian C. Ayers, MBA1, Angela Kokkosis, MD2, Apostolos Tassiopoulos, MD2

Patient Characteristics

TCARN=88

Age, Mean 72.3

Age 75+ 45%

Age 80+ 27%

Female 33%

Medical History

Diabetes 36%

Hypertension 93%

CHF 32%

CAD 56%

Current Smoker

30%

Symptomatic 38%

1. Division of Vascular Surgery, Department of Surgery, University of Rochester Medical Center, Rochester, NY2. Division of Vascular and Endovascular Surgery, Stony Brook Medicine, NY

Lesion Characteristics

TCARN=88

Side

Right 55%

Left 45%

Stenosis, Mean 87.6%

Length 20.0mm

Type

Atherosclerosis 82%

Re-stenosis CEA 13%

Re-stenosis stent 6%

Calcification

None 6%

<25% 52%

26 - 50% 23%

51 – 99% 13%

100% 6%

Procedure Detail

TCARN=88

Time (Mean)

Procedure 91.7min

Flow Reversal 13.3min

Fluoro 6.5min

Tech Success 98%

Pre-Dilate 48%

Med Mgmt

DAPT 95%

Statin 95%

Number of Stents

One 91%

Two 8%

Local Anesthesia 32%

30 Day Outcomes TCARN=88

Stroke 1.1% (1)

MI 0% (0)

Death 0% (0)

CONCLUSIONS:• All patients tolerated flow reversal.

There were no MI or death within 30 day. One patient developed a post-op watershed event (1.1%).

• In comparison to the ROADSTER trial, there were more symptomatic patients (26% vs 38%) with a similar profile of major comorbidities.

• In spite of these high risk factors, the data demonstrate an excellent safety profile with only a single post-op neurologic event.

A Multi-Institutional Analysis of TCAR Compared to CEAAlexander H. King, MS1, Vikram S. Kashyap, MD1, Mazin I. Foteh, MD2, Matthew Janko, MD1, Jeffrey Jim, MD3, Raghu Motaganahalli, MD4, Jeffrey M. Apple, MD2, SaideepBose, MD1, Norman H. Kumins, MD1 - VAM, June 2018

Baseline Characteristics TCARN=292

CEAN=371 P-value

Male, Gender 65.8% 59.6% 0.06

Age (yrs) 71.1 70.7 0.73

Symptomatic 35.3% 38.5% 0.42

Diabetes 45.9% 35.6% 0.01

Hyperlipidemia 82.9% 72.8% 0.02

Hypertension 91.1% 87.9% 0.21

Coronary Artery Disease 53.4% 36% <.01

PVD 24.7% 27.9% 0.49

Smoking History 59.6% 72.0% <0.01

Renal Insufficiency 21.2% 12.7% <0.01

Overall Outcomes TCARN =292

CEAN = 371 P-value

Stroke/MI/Death – 30 Day 2.1% 2.4% 0.80

Stroke/Death – 30 Day 1.4% 1.9% 0.76

Stroke – 30 Day 1.0% 1.1% 1.00

Mortality – 30 Day 0.3% 0.8% 0.63

MI – 30 Day 0.7% 0.5% 1.00

Stroke/Death – 1 Year 4.6% 6.8% 0.32

Stroke – 1 Year 2.8% 3.0% 1.00

Mortality – 1 Year 1.8% 3.9% 0.15

CNI 0.3% 4.1% <.01

Unresolved at 6 Months 0.0% 1.9% 0.02

1. Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH2. Cardiothoracic and Vascular Surgeons, Austin, TX3. Division of Vascular Surgery, Washington University, St. Louis, MO4. Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, IN

METHODS:• Multi-center, retrospective review of patients undergoing

TCAR or CEA between 2013-2017• TCAR patients had higher risk factors and most were enrolled

in prospective trials

SUMMARY: • Stroke and death rates were the same at 30 days and 1 year• TCAR demonstrated a significant decrease in CNI• “Particularly in patients at high risk for surgery, TCAR should

be considered in treatment of carotid artery disease.”

ROADSTER StudyProspective, Multi-Center, Single-Arm Trial of TCAR in High Surgical Risk Patients

with Carotid Stenosis - Pivotal + Continued Access Results

1J Vasc Surg 2015;62:227-352 N Engl J Med 2010;363:11-233 Stroke 2011;42(12):3484-904 Circulation 2012;125:2256-2264

Primary EndpointAll stroke, MI & death at 30-days

Clinical Results

*Hierarchical

Demographics and Technical ResultsDemographics and Technical Results Clinical Results

ROADSTER Pivotal ITT1 (n=141) + Continued Access (n=78) = 219

ROADSTER(n=219)

ROADSTER(n=219)

Age (mean)

Age ≥75

Female

Symptomatic

Local Anesthesia

Reverse Flow Time (median)

72.3 ±8.6

41.6%

37.9%

22.4%

47.1%

10 minutes

S/D/MI*

Major Stroke

Minor Stroke

Death

MI

All Stroke

Cranial Nerve Injury

CNI Unresolved 6 mths

8

0

3

2

3

3

1

0

0%

1.4%

0.9%

1.4%

1.4%

3.7%

0.5%

0.0%

CREST2 CEA(n=1,240)

69.2 ±8.7

28.5%3

33.6%

52.7%

10.0%

n/a

Standard RiskHigh Surgical Risk

CREST2 CEA(n=1,240)

0.6%

1.7%

0.3%

2.3%

2.3%

4.5%

5.3%

2.1%4

Standard RiskHigh Surgical Risk

PROOF Study Safety Results1,2 Result (n=75)

Subjects completing 30-day follow-up71

(94.7%)

Primary Endpoint:Composite of any major stroke, myocardial infarction and death from the index procedure through the 30-day post-procedural period

0/71 (0%)

Minor strokeMinor contralateral stroke adjudicated as not device or procedure-related

1/71(1.3%)

Cranial nerve injury (Hoarseness)2/71

(2.7%)

PROOF StudyTCAR – First in Man Experience

1. J Vasc Surg 2011;54:1317-232. J Endovasc Ther. 2017 Apr;24(2):265-2703. Lancet Neurol. 2010 Apr;9(4):353-624. J Am Coll Cardiol. 2012 Jan 19. [Epub ahead of print]

Study Procedure Embolic Protection

Patients

% w/ NewDW-MRI Lesions

ICSS3 CEA Clamp, backbleed 107 17%

PROOF2 TCAR Proximal Flow Reversal 56 23%

(18% Ipsilateral)

PROFI4 Transfemoral CAS

Proximal occlusion (MoMA) 31 45%

ICSS3 Transfemoral CAS Distal filter (various) 51 73%

PROFI4 Transfemoral CAS

Distal filter (Emboshield) 31 87%

TCAR Demonstrates TCD Embolization Rates Comparable to CEA

Vermassen, et al J Endovasc Ther April 2016 23: 249-254

• No significant differences in number of emboli (p=0.486) and seconds of embolic showers (p=0.493) between TCAR and CEA

– TF-CAS showed significantly higher emboli rates compared with CEA or TCAR (p<0.001)

Pre-Protection

• No significant difference b/w TCAR & CEA (p=0.177)

• TF-CAS generated more discrete emboli than TCAR & CEA (p<0.001)

Protection

• No significant difference b/w TCAR & CEA (p=0.424)

• TF-CAS generated more embolic events than TCAR & CEA (p<0.001)

Post-Protection

• All 3 techniques showed similar rates of embolic events

Pre-protectionBefore clamping, filter deployed, or reverse flow established

ProtectionUntil clamp removed, filter retrieved, or antegrade flow reestablished

Post-protection

After clamp/filter removed, or normal flow established

TransCarotid Artery Revascularization (TCAR) vs. Transfemoral Carotid Artery Stenting (TF-CAS) in the SVS Vascular Quality Initiative – J Vasc Surg Vol69, Issue 1, Pages 92–103.e2Malas MB, MD, MHS; Dakour Aridi H, MD, Wang GJ, MD; Kashyap VS, MD; Motaganahalli R, MD; Eldrup-Jorgensen J, MD; Cronenwett JL, MD; Schermerhorn ML, MD

In-Hospital Outcomes TCAR N=638

TF-CASN=10,136 P-value

Stroke 1.4% 2.0% 0.29

Stroke/TIA 1.9% 3.3% 0.04

Stroke/TIA/Death 2.2% 3.8% 0.04

Myocardial Infarction 1.1% 0.6% 0.15

TIA Alone 0.5% 1.3% 0.06

Any Neurological Event 1.9% 3.2% 0.06

Neurological Events/Death 2.2% 3.7% 0.05

Discharge Destination

Home 93.9% 90.8% 0.01

Rehab Unit 3.0% 6.0%

30-Day Mortality 0.9% 1.3% 0.42

Baseline Characteristics TCARN=638

TF-CASN=10,136 P-value

Age, Median (IQR) 74 (66-80) 70 (63-77 <.001

Female 35.1% 35.5 0.83

Coronary Artery Disease 47.3% 34% <.001

CHF 19.8% 15.3% <.01

Prior CABG/PCI 41.5% 19.5% <0.001

Hypertension 91.2% 90.0% 0.31

COPD 26.5% 25.7% .64

Symptomatic 33.5% 41.9% <.001

Prior Ipsilateral CEA or CAS 18.7% 26.9% <.001

Prior Contralateral CEA or CAS 18.3% 13.2% <.001

Anatomic High Risk 50.6% 46.2% 0.03

Medical High Risk 59.4% 41.4% <.001

Local Anesthesia 21% 88.5% <.001

• The rates of in-hospital TIA/Stroke as well as TIA/Stroke/Death were significantly higher with TF-CAS compared to TCAR• TIA/Stroke - 3.3% TF-CAS vs 1.9% TCAR (P=0.04)• TIA/Stroke/Death – 3.8% TF-CAS vs 2.2% TCAR (P=0.04)

• On multi-variable analysis, TF-CAS was associated with TWICE the odds of in-hospital neurologic events and TIA/Stroke/Death compared to TCAR

• “Our results show that patients undergoing TCAR had significantly higher medical comorbidities, but half the risk of in-hospital TIA/Stroke/Death compared to patients undergoing TF-CAS.…this is the first study to confirm the benefit of TCAR compared to TF-CAS in real-world practice.” – Dr. Mahmoud Malas


TCAR - Clinical Studies & Publications

PROOF ROADSTERTCD

CEA v TCAR vs TF-CAS

TCAR vs CEAVQI

TCAR vs TF-CASVQI ROADSTER 2

Study typeFirst In Man& DW-MRI Sub-Study

US Pivotal IDE + Continued

Access

Single Center Transcranial Doppler

TCAR Surveillance Project

TCAR Surveillance Project

US Post-Market Registry

Patients 75 219 34 2,545 638 600+

Profile All-comers HSRSym & Asx

CEA vs TCAR vs TF-CAS

HSRSym & Asx

HSRSym & Asx

HSRSym & Asx

TCAR Outcomes

• 0.0% Major S/D/MI

• 1.3% Minor contralateral stroke

• 17.9% New ipsilateral DWI lesions

• 1.3% All stroke (ITT)

• 0.7% All stroke (PP)

• 0.0% Major stroke

• 0.7% MI• 0.0% CNI at

6mths

• No significant differences in number of emboli and seconds of embolic showers btw TCAR and CEA

• 1.4% In-hospital stroke• 1.8% Stroke/death• AE’s statistically similar

between TCAR & CEA• TCAR shorter procedure &

10x lower CNI rate

• 1.4% In-hospital stroke

• 1.9% Stroke/TIA• 2.2%

Stroke/TIA/Death• 1.1% MI

Procedural Data &

Conclusions

• 53% Local anesthesia

• 76min OR time• 99% Tech

success

• TF-CAS showed significantly higher emboli rates compared with CEA or TCAR (p<0.001)

• TCAR patients significantly higher medical risk

• Statistically similar rates of stroke

• TCAR statistically shorter OR time & 10x lower rate of CNI

• TCAR had significantly higher medical comorbidities, but half the risk of in-hospital TIA/Stroke/Death compared TF-CAS patients

Status / Publication

J Endovasc Ther. 2017 Apr;24(2):265-

270

J Vasc Surg. 2015 Nov;62(5):1227-34

J Endovasc Ther April 2016 23: 249-254

Presented VEITH, 2018M. Schermerhorn, MD

J Vasc Surg. 2018 Vol69 Issue 1 , 92 - 103.e2

Currently Enrolling

PROOF - https://www.ncbi.nlm.nih.gov/pubmed/28335706TCAR vs TF-CAS - https://www.jvascsurg.org/pb/assets/raw/Health%20Advance/journals/ymva/Malas-22.pdf

https://www.ncbi.nlm.nih.gov/pubmed/28335706

https://www.jvascsurg.org/pb/assets/raw/Health%20Advance/journals/ymva/Malas-22.pdf

Case #1• 83 year old male with a history of HTN and

HLD presents to the ED with hoarseness

• Has known left internal carotid artery aneurysm that was stented at OSF in Georgia

• Arrives for evaluation because hoarseness is worsening

Case #1

Case #2• 60 year old male with a history of HTN, stroke, HLD and

NSTEMI with vFib arrest within the last 6 months

• Has 2 TIA with right arm weakness and numbness as well as slurred speech within last year

• Was lost to follow up due to NSTEMI, was being worked up for carotid revascularization

• Has a high grade left ICA lesion

Concluding Thoughts• Outcomes in all are evolving and positive

– Especially for carotid artery stenting

• The best evidence supports calculated and selective use of carotid stents by experts so patients have better outcomes

• The take away from CREST should be that non-inferiority does not indicate a competitive role between CEA and CAS…

…But instead these modalities should have complementary role in carotid artery revascularization

Thank You

Carotid Artery Disease and Carotid StentingAsymptomatic Carotid Artery Stenosis • SMART Study –...

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