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  • Carotid Endarterectomy, TransFemoral Carotid Artery Stenting

    and TransCarotid Artery Revascularization (TCAR) – Data From

    The SVS Vascular Quality Initiative (VQI)

    MAHMOUD MALAS, MD, MHS, RPVI, FACS Professor and Chief Vascular and Endovascular Surgery

    Vice Chair of Surgery for Clinical Research University of California San Diego

    Professor of Epidemiology Johns Hopkins Bloomberg School of Public Health

  • Presenter Disclosure Information Mahmoud B. Malas Principal Investigator

    1. CREST 2. ACT I 3. CAPTURE II 4. CHOICE 5. FREEDOM 6. ROADSTER

    7. SAPHIRE W 8. ROADSTER II 9. CREST II 10.CREST Companion Study 11. CREST H 12. ROADSTER Long-Term Follow up Study

    • National/International Principal Investigator for “The ROADSTER Long Term Follow Up”

  • Grube E. et al, Am Journal Cardiol 2006;

    Endpoint CAS CEA Risk Ratio (95% CI)

    P

    Stroke or death to 120 days, No. (%)

    153 (8.9)

    99 (5.8)

    1.53 (1.20 – 1.95)

    .001

    Meta-Analysis of SPACE, EVA-3S, and ICSS

  • CAS vs. CEA Hazard Ratio 95% CI P-Value

    Stroke 4.1 vs. 2.3% HR = 1.79; 95% CI: 1.14-2.82 0.01

    MI 1.1 vs. 2.3% HR = 0.50; 95% CI: 0.26-0.94 0.03

    CAS vs. CEA Hazard Ratio, 95% CI P-Value 7.2 vs. 6.8% HR = 1.11; 95% CI: 0.81-1.51 0.51

     Peri-procedural Stroke and MI

     Primary Endpoint ≤ 4 years

  • Carotid Endarterectomy

    (CEA) 65 years: Gold standard

    82% of

    procedures

    Low stroke rates & Higher surgical morbidity

    Crossing the aortic arch

    Crossing the lesion

    Trans-Femoral Carotid Artery Stenting

    (TF-CAS) 15 years on Market

    HIGH (2x) peri-procedural stroke risk

    18% of

    procedures

    CREST CNI2: 2.1% CNI unresolved at 6 months (80% motor) CREST MI1: 2.3% CEA vs 1.1% TF CAS

    CREST 30-day All Stroke1: 2.3% CEA vs 4.1% TF CAS

    1 CREST Trial: N Engl J Med 2010;363:11-23 2 Circulation. 2012;125:2256-2264

    Mis- Aligned Distal Filters

    TFCAS vs. CEA

  • Crossing the

    lesion

    Crossing the aortic arch

    Stroke after TFCAS

  • ICSS: Silent DWI Lesions After CAS

    MRI Diffusion Weighted Abnormalities Assessed 1 to 7 days after the procedure

    CAS (n = 108)

    CEA (n = 92)

    HR (95% CI)

    P

    DWI lesions

    50 (46.3%)

    13 (14.1)

    5.24 (2.61-10.3) 0.001

  • Surgically Inspired CEA-like Neuroprotection

  • ENROUTE® TransCarotid Neuroprotection & Stent System

  • TCAR Best Practices And Techniques

  • ROADSTER 1&2: Clinical Outcomes

    FDA Population Analysis

    ROADSTER 1 ROADSTER 2

    n=219 n=638

    Stroke/Death/MI 6 3.7% 10 1.7%

    Stroke 1 1.4% 4 0.7%

    Death 2 0.9% 1* 0.2%

    MI 3 1.4% 5 0.9%

    Stroke/Death 3 1.5% 5 0.9%

    Neurological Death 0 0.0% 0 0.0%

    *One patient expired ~2 weeks post-procedure due to ruptured AAA.

  • TCD Transfemoral CAS vs CEA vs TCAR

    TCAR: avoids the arch, offers complete proximal protection. Similar to CEA.

  • The PROOF Study DW-MRI Hits Similar to CEA

    Study Procedure Embolic Protection Patients New Ipsilateral DWI Lesions

    ICSS2 CEA Clamp, backbleed 107 17%

    PROOF3 TCAR Proximal clamp, reversed flow 56 18%

    PROFI1 Transfemoral CAS Proximal occlusion (MoMA) 31 45%

    ICSS2 Transfemoral CAS Distal filter (various) 51 73%

    PROFI4 Transfemoral CAS Distal filter (Emboshield) 31 87%

    1. J Vasc Surg 2011;54:1317-23 2. J Endovasc Ther. 2017 Apr;24(2):265-270 3. Lancet Neurol. 2010 Apr;9(4):353-62 4. J Am Coll Cardiol. 2012 Jan 19. [Epub ahead of print]

  • 76

    171

    0

    20

    40

    60

    80

    100

    120

    140

    160

    180

    Procedure Duration

    Transcarotid CAS CEA

    CEA CREST Study

    Transcarotid CAS ROADSTER Study

    n=208

    Procedure Time M

    in ut

    es

    1. ROADSTER Presentation – Late Breaking Trials, VIVA 2014, C. Kwolek, MD 2. Stroke. 2012;43:00-00.

    ROADSTER vs CREST – Mean Procedure Times (minutes)1,2

  • 10 Minutes

    31 Minutes

    0

    5

    10

    15

    20

    25

    30

    35

    Procedure Duration

    Transcarotid CAS

    CEA NASCET Study

    n=1,415

    Transcarotid CAS ROADSTER Study

    n=208

    Reverse Flow Vs. CEA Clamp Time M

    in ut

    es

    1. ROADSTER Presentation – Late Breaking Trials, VIVA 2014, C. Kwolek, MD 2. Stroke. 1999;30:1751-1758

    ROADSTER vs NASCET 1,2

  • One-Year Outcomes • Stroke rate: 0.6% • Mortality: 4.2% • 99% stroke free at one year • 95% stroke free survival

  • TCAR Surveillance Project (TSP)

  • Objectives of TSP

     Monitor the safety and effectiveness of stents placed directly into the carotid artery while reversing blood flow within the carotid artery to reduce stroke risk.

     Compare this less-invasive surgical procedure with standard carotid endarterectomy in centers that participate in the Society for Vascular Surgery Vascular Quality Initiative.

    Provide “REAL-WORLD” Outcomes

  • • Inclusion Criteria: Patients undergoing TCAR or CEA who are considered high surgical risk as defined by the CMS criteria

    https://clinicaltrials.gov/ct2/show/NCT02850588?term=TCAR+%2C+Surveillance&rank=1

    Who is Eligible for TCAR?

    https://clinicaltrials.gov/ct2/show/NCT02850588?term=TCAR+,+Surveillance&rank=1

  • Anatomic High-Risk Inclusion Criteria: • Contralateral carotid artery

    occlusion • Tandem stenosis >70% • High cervical carotid artery

    stenosis • Restenosis after carotid

    endarterectomy • Bilateral carotid artery stenosis

    requiring treatment • Hostile neck which the

    Investigator deems safe for transcarotid access including but not limited to prior neck irradiation, prior radical neck dissection or cervical spine immobility

    Clinical High-Risk Inclusion Criteria:

    ≥ 75 years of age ≥ 2-vessel coronary artery disease and history of angina of any severity  Unstable angina or Canadian Cardiovascular Society (CCS) angina class 3 or 4  Congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV Known severe left ventricular dysfunction with LVEF 72 hours and < 6 weeks prior to procedure.  Severe pulmonary disease (COPD) with either FEV1

  • TCAR vs TFCAS

  • TFCAS N = 2430

    (%)

    TCAR N = 2430

    (%)

    Relative Risk (95% CI)

    P-value

    Stroke/Death 2.9 1.5 0.52 (0.35-0.77)

  • TCAR vs CEA

    Schermerhorn ML, Liang P, Dakour-Aridi H, Kashyap VS, Wang GJ, Nolan BW, Cronenwett JL, Eldrup-Jorgensen J, Malas MB. In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative. Journal of vascular surgery. 2019 Jun 18.

    • 1,182 patients undergoing TCAR vs. 10,797 patients who underwent CEA. • Similar in-hospital stroke/death rates between TCAR and CEA, despite a

    substantially higher medical risk in patients undergoing TCAR. • Lower CNI after TCAR vs. CEA

  • Total Cohort 51,986

    CEA (n=44,442)

    CEA (n=6,135)

    TCAR (n=7,544)

    TCAR (n=6,135)

    After Propensity Score Matching

    Initial Cohort

  • Baseline Characteristics Before Propensity-Score Matching

    CEA (N=44,442) TCAR (N=7,544) P-value Mean Standardized

    Difference*

    Median Age in years (IQR) 71 (65-77) 74 (67-80)

  • Baseline Characteristics after Propensity-Score Matching

    CEA (N=6,135) TCAR (N=6,135) P-value Mean

    Standardized Difference*

    Median Age, IQR 74 (67-80) 74 (67-80) 0.08 0.024 Age ≥75 years, n(%) 2,927 (47.7) 2,911 (47.5) 0.68 0.005 Female Gender, n (%) 2,189 (35.7) 2,217 (36.1) 0.46 0.010 Non-White Race, n (%) 601 (9.8) 614 (10.0) 0.69 0.007 Symptomatic Status, n (%) 2,387 (38.9) 2,384 (38.9) 0.94 0.001 HTN, n (%) 5,601 (91.3) 5,571 (90.8) 0.35 0.017 DM, n (%) 2,401 (39.1) 2,379 (38.8) 0.68 0.007 CAD, n (%) 2,999 (48.9) 2,970 (48.4) 0.42 0.009 Prior CABG/PCI, n (%) 2,390 (39.0) 2,450 (39.9) 0.11 0.020 CHF, n (%) 984 (16.0) 1,062 (17.3) 0.02 0.034 COPD, n (%) 1,540 (25.1) 1,654 (27.0) 0.02 0.042 CKD, n (%) 2,253 (37.3) 2,312 (38.5) 0.11 0.026 Dialysis, n (%) 76 (1.2) 111 (1.8) 0.02 0.049 Smoking 0.86 0.007 Prior Smoker 3,216 (52.4) 3,194 (52.1) Current Smoker 1,324 (21.6) 1,327 (21.7) Prior Ipsilateral CEA, n (%) 410 (6.7) 465 (7.6) 0.01 0.035 Prior Ipsilateral CAS, n (%) 45 (0.7) 63 (1.0) 0.08 0.031 Ipsilateral Stenosis >= 80% 3,161 (51.5) 3,165 (51.6) 0.92 0.001 Contralateral CEA/CAS 932 (15.2) 960 (15.7) 0.49 0.012 Preoperative Medications, n (%)

    Aspirin 5,512 (89.9) 5,436 (88.6) 0.004 0.040 Statin 5,480 (89.3) 5,471 (89.2) 0.74 0.005

    P2Y12-Receptor Antagonists 5,287 (86.2) 5,212 (85.0)

  • In-Hospital Outcomes after Propensity Score Matching

    CEA (N=6,135) TCAR (N=6,135) TCAR vs. CEA

    N (%) N (%) Relative Risk (95% CI) P-value

    Stroke/Death 94 (1.5) 94 (1.5) 1.0 (0.75-1.33) 1.00 Death 25

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