VESS09 - Physiologic Risk Factors Increase the Risk of Myocardial Infarction but Not Stroke or Death after Transcarotid Artery Revascularization in Prospective Trials

Objectives: Current high-risk criteria to undergo transcarotid artery revascularization (TCAR) are categorized into anatomical (ANAT) and physiologic (PHYS) factors. Patients with physiologic criteria are deemed to have higher overall surgical risk due to more significant comorbidities. Our aim is to study the incidence of stroke, myocardial infarction (MI), death, and combined endpoints in patients who underwent TCAR comparing ANAT vs. PHYS risk factors.

Methods: An analysis of the prospectively collected data from the ROADSTER (pivotal), ROADSTER2 (FDA indicated post-market), and ROADSTER Extended Access TCAR trials was performed. All patients (n=851) were included and stratified based on high risk ANAT criteria (contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stent, hostile neck with previous neck irradiation, neck dissection, or cervical spine immobility) or high-risk PHYS criteria (age > 75 years, multi-vessel coronary artery disease, history of angina, congestive heart failure NYHA class III/IV, left ventricular ejection fraction < 30%, recent MI, severe chronic obstructive pulmonary disease (COPD), permanent contralateral cranial nerve injury, or chronic renal insufficiency). For trial inclusion, asymptomatic patients had > 80% carotid stenosis and symptomatic patients had > 50% stenosis. Primary outcome measures were stroke, death, and MI at 30 days. Data was statistically analyzed with the χ2 test as appropriate.

Results: There were 851 patients categorized into ANAT only risk factors (n = 372) or having at least one PHYS risk factor (n = 479). The ANAT subset had 74.5% asymptomatic patients, while the PHYS subset had 76.6%. General anesthesia was employed similarly in both groups (67.7% ANAT vs. 68.1% PHYS). MI occurred in 8 PHYS (1.7%) patients all of whom were asymptomatic and in no ANAT patients (p = .01). There was no significant difference in stroke rates in ANAT vs. PHYS patients (p = .61). Combined stroke, death, and MI rate was 2.1% in the ANAT cohort, compared to 4.2% in the PHYS cohort (p = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any statistically significant differences (Table I). Multivariate analysis was performed and did not reveal any significant co-variates.

Conclusions: Patients who underwent TCAR based on high-risk PHYS factors had higher rates of MI compared to patients who qualified with ANAT criteria only. However, these patients experienced similar rates of stroke, death, and combined endpoints. Further investigation is needed with larger cohorts and longer follow up.