Transcarotid Artery Revascularization versus Transfemoral Carotid Artery Stenting for Treatment of Carotid Artery Stenosis Patric Liang, MD; Marc L. Schermerhorn, MD; Jens Eldrup-Jorgensen, MD; Jack L. Cronenwett, MD; Brian W. Nolan, MD; Vikram S. Kashyap, MD; Grace J. Wang, MD, MSCE; MD; Raghu L. Motaganahalli, MD; Mahmoud B. Malas, MD, MHS

Disclosures MS is a consultant for Silk Road Medical, Medtronic, Endologix, Cook, and Abbott VK is a National Co-PI for ROADSTERII. RM is a consultant and proctor for Silk Road Medical. MM is a site PI for ROADSTERI and ROADSTERII, and National PI for ROADSTERI long term follow-up study. PL, JJ, JC, BN, and GW have no disclosures.

Limited to small sample size Background Objective Methods Results Conclusion Pivotal randomized trails have found higher periprocedural stroke risk for transfemoral carotid stenting (tfCAS) compared to endarterectomy Transcarotid revascularization (TCAR) with flow reversal was developed to eliminate the high embolic-risk maneuvers inherent to tfCAS Preliminary analysis from the VQI TCAR Surveillance Project showed lower neurological complications based on embolic events manifested as transient ischemic attack Limited to small sample size

TCAR and tfCAS Trend in the VQI Background Objective Methods Results Conclusion TCAR and tfCAS Trend in the VQI Year % CAS performed via TCAR 2016 5.9% 2017 26.0% 2018 46.5% 2019 (April) 56.3%

Background Objective Methods Results Conclusion Examine perioperative and one-year outcomes of patients undergoing TCAR and tfCAS in the VQI TCAR Surveillance Project.

Prospective registry, clinical trial (NCT02850588) Background Objective Methods Results Conclusion Prospective registry, clinical trial (NCT02850588) Study Period: September 2016 to April 2019 Inclusion - TCAR and tfCAS procedures for atherosclerotic or intimal hyperplasic disease Exclusion – Concomitant planned intracranial procedures Unknown presenting symptom status or presenting symptom severity Primary Outcome In-hospital, 30-day, and 1-year stroke/death Secondary Outcomes Stroke, death, myocardial infarction, bleeding complication, procedure time, fluoroscopy time, contrast volume, CMS discharge criteria (failed discharge home or LOS >2 days) Propensity Score Matched Analysis

Baseline Characteristics Background Objective Methods Results Conclusion Baseline Characteristics tfCAS N = 6640 TCAR N = 5251 P-value Age, y 70 + 9.7 73 + 9.4 <.001 Symptomatic TIA Stroke 65% 23% 43% 49% 20% 30% Prior CEA/CAS 21% 17% Risk Factors Coronary Artery Disease Congestive Heart Failure Hypertension Chronic Kidney Disease (GFR<60) 44% 16% 89% 35% 51% 19% 91% 40% .002 CMS High-Risk CEA Criteria Anatomic Medical 37% 50% 57%

Baseline Characteristics Background Objective Methods Results Conclusion Baseline Characteristics tfCAS N = 6640 TCAR N = 5251 P-value Preoperative Medications Aspirin P2Y12 inhibitors Statin 87% 77% 83% 90% 89% <.001 Physician Carotid Stent Volume Low (0-3) Medium (4-24) High (25-87) 24% 56% 20% 26% 18% .01 Center Carotid Stent Volume Low (0-14) Medium (15-66) 59% 23% 25% 16%

Propensity Score Matching Background Objective Methods Results Conclusion Propensity Score Matching 3286 Matched Pairs

Technical Outcomes tfCAS N = 3286 TCAR P-value Technical Failure 1.2% Background Objective Methods Results Conclusion Technical Outcomes tfCAS N = 3286 TCAR P-value Technical Failure 1.2% 0.5% <.001 Unable to access CCA 0.4% 0.1% .003 Unable to cross carotid lesion 0.6% 0.2% .002 Unable to deploy stent .59 Embolic device placement failure 5.8% 0.3% Unable to insert device 1.0% Delete?

In-Hospital Outcomes tfCAS N = 3286 TCAR P-value Stroke/Death 3.1% Background Objective Methods Results Conclusion In-Hospital Outcomes tfCAS N = 3286 TCAR P-value Stroke/Death 3.1% 1.6% <.001 Stroke 2.4% 1.3% .001 Death 1.0% 0.4% .008 Myocardial Infarction 0.3% 0.2% .47 Bleeding Complication 0.8% .04

In-Hospital Outcomes tfCAS N = 3286 TCAR P-value Background Objective Methods Results Conclusion In-Hospital Outcomes tfCAS N = 3286 TCAR P-value Procedural Time (mins) 72 + 41 74 + 30 .02 Fluoroscopy Time (mins) 19 + 13 6.1 + 8.6 <.001 Contrast Volume 94 + 57 37 + 27 Failed CMS Discharge Criteria Length of stay >2 days Failed Discharge Home 23% 19% 13% 16% 14% 7.3%

Myocardial Infarction 0.3% 0.1% .06 .74 Background Objective Methods Results Conclusion Symptomatic N = 3658 Asymptomatic N=2876 tfCAS N = 1829 TCAR P-value N = 1438 Stroke/Death 4.2% 2.1% <.001 1.5% 1.0% .32 Stroke 3.1% 2.0% .035 1.3% 0.7% .13 Death 0.5% .002 0.2% 0.4% Myocardial Infarction 0.3% 0.1% .06 .74 Bleeding Complication .02 Failed CMS Discharge Criteria Length of stay >2 days Failed Discharge Home 32% 26% 21% 22% 18% 11% 9.9% 9.2% 2.8% 10% 9.0% .80 .85 .18

Protamine Use in TCAR No Protamine N = 944 Protamine P-value Background Objective Methods Results Conclusion Protamine Use in TCAR No Protamine N = 944 Protamine P-value Stroke/Death 2.2% 1.6% .32 Stroke 2.0% 1.1% .09 Death 0.7% 0.5% .56 Myocardial Infarction 0.2% 0.3% .65 Any Bleeding Complication 8.3% 2.8% <.001 Interventional treatment 3.6% 1.0% Blood Transfusion 3.9% 1.2%

30-day Outcomes tfCAS N = 3286 TCAR P-value Stroke/Death 3.7% 1.9% Background Objective Methods Results Conclusion 30-day Outcomes tfCAS N = 3286 TCAR P-value Stroke/Death 3.7% 1.9% <.001 Stroke 2.5% 1.3% Death 1.5% 0.8% .007

Freedom From Stroke/Death: 1-Year Background Objective Methods Results Conclusion Freedom From Stroke/Death: 1-Year TCAR tfCAS Number at Risk Transfemoral Transcarotid 94.9% vs 90.5% HR 0.55, 95%CI 0.46-0.66, P < .001

The stroke/death differences persistent up to one-year Background Objective Methods Results Conclusion TCAR is associated with lower rates of stroke and death compared to tfCAS The stroke/death differences persistent up to one-year Benefits from TCAR are particularly compelling for symptomatic carotid disease Protamine use in TCAR results in significantly decreased bleeding complications without differences in thrombotic complications TCAR with flow reversal should be preferred carotid stenting technique