Transcarotid Artery Revascularization versus Transfemoral Carotid Artery Stenting

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.

Background Objective Methods Results Conclusion • Pivotal randomized trails have found higher periprocedural stroke risk for transfemoral carotid stenting (tf. CAS) compared to endarterectomy • Transcarotid revascularization (TCAR) with flow reversal was developed to eliminate the high embolic-risk maneuvers inherent to tf. CAS • 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

Background Objective Methods Results Conclusion TCAR and tf. CAS 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 tf. CAS in the VQI TCAR Surveillance Project.

Background • • • Objective Methods Results Conclusion Prospective registry, clinical trial (NCT 02850588) • Study Period: September 2016 to April 2019 Inclusion • TCAR and tf. CAS 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

Background Objective Methods Results Conclusion Baseline Characteristics tf. CAS N = 6640 TCAR N = 5251 P-value Symptomatic TIA Stroke 70 + 9. 7 65% 23% 43% 73 + 9. 4 49% 20% 30% <. 001 Prior CEA/CAS 21% 17% <. 001 Risk Factors Coronary Artery Disease Congestive Heart Failure Hypertension Chronic Kidney Disease (GFR<60) 44% 16% 89% 35% 51% 19% 91% 40% <. 001. 002 <. 001 CMS High-Risk CEA Criteria Anatomic Medical 44% 37% 50% 57% <. 001 Age, y

Background Objective Methods Results Conclusion Baseline Characteristics Preoperative Medications Aspirin P 2 Y 12 inhibitors Statin Physician Carotid Stent Volume Low (0 -3) Medium (4 -24) High (25 -87) Center Carotid Stent Volume Low (0 -14) Medium (15 -66) High (25 -87) tf. CAS N = 6640 TCAR N = 5251 P-value 87% 77% 83% 90% 87% 89% <. 001 24% 56% 20% 18% 59% 23% 26% 56% 18% 25% 59% 16% . 01 <. 001

Background Objective Methods Results Propensity Score Matching 3286 Matched Pairs Conclusion

Background Objective Methods Results Conclusion Technical Outcomes tf. CAS N = 3286 TCAR N = 3286 P-value 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 0. 2% . 59 5. 8% 0. 3% <. 001 1. 0% 0. 1% <. 001 Technical Failure Embolic device placement failure Unable to insert device

Background Objective Methods Results Conclusion In-Hospital Outcomes Stroke/Death Stroke Death Myocardial Infarction Bleeding Complication tf. CAS N = 3286 3. 1% 2. 4% 1. 0% 0. 3% 0. 8% TCAR N = 3286 1. 6% 1. 3% 0. 4% 0. 2% 1. 3% P-value <. 001. 008. 47. 04

Background Objective Methods Results Conclusion In-Hospital Outcomes Procedural Time (mins) Fluoroscopy Time (mins) Contrast Volume Failed CMS Discharge Criteria Length of stay >2 days Failed Discharge Home tf. CAS N = 3286 72 + 41 19 + 13 94 + 57 23% 19% 13% TCAR N = 3286 74 + 30 6. 1 + 8. 6 37 + 27 16% 14% 7. 3% P-value. 02 <. 001

Background Objective Methods Results Symptomatic N = 3658 tf. CAS N = 1829 TCAR N = 1829 4. 2% Stroke Death Conclusion Asymptomatic N=2876 P-value tf. CAS N = 1438 TCAR N = 1438 P-value 2. 1% <. 001 1. 5% 1. 0% . 32 3. 1% 2. 0% . 035 1. 3% 0. 7% . 13 1. 5% 0. 5% . 002 0. 2% 0. 4% . 32 Myocardial Infarction 0. 3% 0. 1% . 06 0. 3% . 74 Bleeding Complication 0. 7% 1. 3% . 13 0. 5% 1. 3% . 02 Failed CMS Discharge Criteria Length of stay >2 days Failed Discharge Home 32% 26% 21% 22% 18% 11% <. 001 9. 9% 9. 2% 2. 8% 10% 9. 0% 2. 0% . 80. 85. 18 Stroke/Death

Background Objective Methods Results Conclusion Protamine Use in TCAR No Protamine N = 944 P-value 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% <. 001 Blood Transfusion 3. 9% 1. 2% <. 001 Stroke/Death

Background Objective Methods Results Conclusion 30 -day Outcomes Stroke/Death Stroke Death tf. CAS N = 3286 3. 7% 2. 5% 1. 5% TCAR N = 3286 1. 9% 1. 3% 0. 8% P-value <. 001. 007

Background Objective Methods Results Freedom From Stroke/Death: 1 -Year TCAR tf. CAS 94. 9% vs 90. 5% HR 0. 55, 95%CI 0. 46 -0. 66, P <. 001 Number at Risk Transfemoral Transcarotid Conclusion

Background Objective Methods Results Conclusion • TCAR is associated with lower rates of stroke and death compared to tf. CAS • 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