Long-term outcomes of carotid endarterectomy vs transfemoral carotid stenting in a Medicare-matched database.

BACKGROUND: Carotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. METHODS: We assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status. RESULTS: A total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio [aHR], 0.46; 95% confidence interval [CI], 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years. CONCLUSIONS: In this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.

Neck radiation is not associated with increased risk of perioperative adverse events after transcarotid artery revascularization or transfemoral carotid artery stenting.

OBJECTIVE: It is unclear whether patients with prior neck radiation therapy (RT) are at high risk for carotid artery stenting (CAS). We aimed to delineate 30-day perioperative and 3-year long-term outcomes in patients treated for radiation-induced stenotic lesions by the transfemoral carotid artery stenting (TFCAS) or transcarotid artery revascularization (TCAR) approach to determine comparative risk and to ascertain the optimal intervention in this cohort. METHODS: Data were extracted from the Vascular Quality Initiative CAS registry for patients with prior neck radiation who had undergone either TCAR or TFCAS. The Student t-test and the χ2 test were used to compare baseline patient characteristics. Multivariable logistic regression and Cox Hazard Proportional analysis were used to compare perioperative and long-term differences between patients with and without prior neck radiation following TCAR and TFCAS. Kaplan-Meier estimator was used to determine the incidence of 3-year adverse events. RESULTS: A total of 72,656 patients (TCAR, 40,879; TFCAS, 31,777) were included in the analysis. Of these, 4151 patients had a history of neck radiation. Patients with a history of neck radiation were more likely to be younger, white, and have fewer comorbidities than patients with no neck radiation history. After adjustment for confounding factors, there was no difference in relative risk of 30-day perioperative stroke (P = .11), death (P = .36), or myocardial infarction (MI) (P = .61) between TCAR patients with or without a history of neck radiation. The odds of stroke/death (P = .10) and stroke/death/MI (P = .07) were also not statistically significant. In patients with prior neck radiation, TCAR had lower odds for in-hospital stroke/death/MI (odds ratio, 0.59; 95% confidence interval [CI], 0.35-0.99; P = .05) and access site complications than TFCAS. At year 3, patients with prior neck radiation had an increased hazard for mortality after TCAR (hazard ratio [HR], 1.24; 95% CI, 1.02-1.51; P = .04) and TFCAS (HR, 1.33; 95% CI, 1.12-1.58; P = .001). Patients with prior neck radiation also experienced an increased hazard for reintervention after TCAR (HR, 2.16; 95% CI, 1.45-3.20; P < .001) and TFCAS (HR, 1.67; 95% CI, 1.02-2.73; P<.001). CONCLUSIONS: Patients with prior neck radiation had a similar relative risk of 30-day perioperative adverse events as patients with no neck radiation after adjustment for baseline demographics and disease characteristics. In these patients, TCAR was associated with reduced odds of perioperative stroke/death/MI as compared with TFCAS. However, patients with prior neck radiation were at increased risk for 3-year mortality and reintervention.

The effect of controlled vs uncontrolled hypertension on outcomes of carotid revascularization procedures.

BACKGROUND: Hypertension (HTN) has been implicated as a strong predictive factor for poorer outcomes in patients undergoing various vascular procedures. However, limited research is available that examines the effect of uncontrolled HTN (uHTN) on outcomes after carotid revascularization. We aimed to determine which carotid revascularization procedure yields the best outcome in this patient population. METHODS: We studied patients undergoing carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), or transcarotid artery revascularization (TCAR) from April 2020 to June 2022 using data from the Vascular Quality Initiative. Patients were stratified into two groups: those with cHTN and those with uHTN. Patients with cHTN were those with HTN treated with medication and a blood pressure of <130/80 mm Hg. Patients with uHTN had a blood pressure of ≥130/80 mm Hg. Our primary outcomes were in-hospital stroke, death, myocardial infarction (MI), and 30-day mortality. Our secondary outcomes were postoperative hypotension or HTN, reperfusion syndrome, prolonged length of stay (LOS) (>1 day), stroke/death, and stroke/death/MI. We used logistic regression models for the multivariate analysis. RESULTS: A total of 34,653 CEA (uHTN, 11,347 [32.7%]), 8199 TFCAS (uHTN, 2307 [28.1%]), and 17,309 TCAR (uHTN, 4990 [28.8%]) patients were included in this study. There was no significant difference in age between patients with cHTN and patients with uHTN for each carotid revascularization procedure. However, compared with patients with cHTN, patients with uHTN had significantly more comorbidities. uHTN was associated with an increased risk of combined in-hospital stroke/death/MI after CEA (adjusted odds ratio [aOR], 1.56; 95% confidence interval [CI], 1.30-1.87; P < .001), TFCAS (aOR, 1.59; 95% CI, 1.21-2.08; P < .001), and TCAR (aOR, 1.39; 95% CI, 1.12-1.73; P = .003) compared with cHTN. Additionally, uHTN was associated with a prolonged LOS after all carotid revascularization methods. For the subanalysis of patients with uHTN, TFCAS was associated with an increased risk of stroke (aOR, 1.82; 95% CI, 1.39-2.37; P < .001), in-hospital death (aOR, 3.73; 95% CI, 2.25-6.19; P < .001), reperfusion syndrome (aOR, 6.24; 95% CI, 3.57-10.93; P < .001), and extended LOS (aOR, 1.87; 95% CI, 1.51-2.32; P < .001) compared with CEA. There was no statistically significant difference between the outcomes of TCAR compared with CEA. CONCLUSIONS: The results from this study show that patients with uHTN are at a higher risk of stroke and death postoperatively compared with patients with cHTN, highlighting the importance of treating HTN before undergoing elective carotid revascularization. Additionally, in patients with uHTN, TFCAS yields the worst outcomes, whereas CEA and TCAR proved to be safer interventions. Patients with uTHN with symptomatic carotid disease treated with CEA or TCAR have better outcomes compared with those treated with TFCAS.

Transcarotid Artery Revascularization Outperforms Transfemoral Carotid Artery Stenting Regardless of Aortic Arch Type or Degree of Atherosclerosis.

OBJECTIVES: The Centers for Medicare and Medicaid Services (CMS) now approve reimbursement for Transfemoral Carotid Artery Stenting (TFCAS) in the treatment of standard-risk patients with carotid artery occlusive disease. TFCAS in patients with complex aortic arch anatomy is known to be challenging with worse outcomes. Transcarotid Artery Revascularization (TCAR) could be a preferable alternative in these patients owing to avoiding the aortic arch and using flow reversal during stent deployment. We aim to compare the outcomes of TCAR versus TFCAS across all aortic arch types and degrees of arch atherosclerosis. METHODS: All patients undergoing Carotid Artery Stenting (CAS) between September 2016 and October 2023 were identified in the VQI database. Patients were stratified into four groups: Group-A (Mild Atherosclerosis and Type I/II Arch), Group-B (Mild Atherosclerosis and Type III Arch), Group-C (Moderate/Severe Atherosclerosis and Type I/II Arch), Group-D (Moderate/Severe Atherosclerosis and Type III Arch). The primary outcome was in-hospital composite stroke or death. ANOVA and χ2tests analyzed differences for baseline characteristics. Logistic regression models were adjusted for potential confounders, and backward stepwise selection was implemented to identify significant variables for inclusion in the final models. Kaplan Meier survival estimates, Log Rank test, and multivariable Cox regression models analyzed hazard ratios for one-year mortality. RESULTS: A total of 20,114 patients were included [Group-A:12,980 (64.53%); Group-B: 1,175 (5.84%); Group-C: 5,124 (25.47%); Group-D: 835 (4.15%)]. TCAR was more commonly performed across the four groups (72.21%, 67.06%, 74.94% 69.22%; p<0.001). Compared to patients with mild arch atherosclerosis, patients with advanced arch atherosclerosis in Group-C and Group-D were more likely to be female, hypertensive, smokers, and have CKD. Patients with Type-III arch in Group-B and Group-D were more likely to present with stroke preoperatively. On multivariable analysis, TCAR had less than half the risk of stroke/death and one-year mortality compared to TFCAS in the patients with the mildest atherosclerosis and simple arch anatomy (group A) (OR=0.43,95%CI:0.31-0.61, p<0.001; HR=0.42,95%CI:0.32-0.57, p<0.001). Group-B patients with similar atherosclerosis but more complex arch anatomy had 70% lower odds of stroke/death with TCAR compared to TFCAS (OR=0.30,95%CI:0.12-0.75, p=0.01). Similar findings were also evident in patients with more severe atherosclerosis and simple arch anatomy (OR=0.66,95%CI:0.44-0.97, p=0.037). There was no significant difference in odds of stroke/death in patients with advanced arch atherosclerosis and complex arch (Group-D) (OR=0.91,95%CI:0.39-2.16, p=0.834). CONCLUSIONS: TCAR is safer than TFCAS in patients with simple and advanced arch anatomy. This could be related to the efficiency of flow reversal vs distal embolic protection. Current CMS decision will likely increase stroke and death outcomes of carotid stenting nationally if multidisciplinary approach and appropriate patient selection are not implemented.

Evaluating postoperative outcomes in patients with hostile neck anatomy undergoing transcarotid artery revascularization versus transfemoral carotid artery stenting.

BACKGROUND: Carotid endarterectomy is relatively contraindicated in patients with a hostile neck anatomy who were historically revascularized with transfemoral carotid artery stenting (TFCAS). As transcarotid artery revascularization (TCAR) has progressively replaced TFCAS, evidence pertaining to hostile neck anatomy and TCAR is necessary to establish its safety and feasibility in this subgroup of patients. Therefore, we analyzed the impact of a hostile neck anatomy on outcomes in patients undergoing TCAR and further compared them with those undergoing TFCAS to establish recommendations for standard of care. METHODS: All patients undergoing TCAR and TFCAS from November 2016 to June 2021 in the Vascular Quality Initiative database were included. Patients were characterized into two groups based on the neck anatomy. Hostile neck anatomy was defined as a history of neck radiation or prior neck surgery including prior carotid endarterectomy or radical neck dissection. Primary outcomes included technical failure, access site complications (hematoma, stenosis, infection, pseudoaneurysm and arteriovenous fistula), and stroke or death. Secondary outcomes included stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and a composite end point of stroke or TIA. Patients with nonatherosclerotic or multiple lesions were excluded from the analysis. Primary analysis was performed with all patients undergoing TCAR and outcomes between patients with hostile and nonhostile neck anatomy were compared. Further analysis included a comparison of patients with a hostile neck anatomy undergoing TCAR and TFCAS. Univariable and multivariable logistic regression was used to assess impact of hostile neck anatomy on postoperative outcomes. Results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, comorbidities, preoperative medications, anesthesia type, and protamine use. RESULTS: Among the 19,859 patients who underwent TCAR during the study period, 3636 (18.3%) had a hostile neck anatomy. On univariate analysis, both groups had comparable outcomes except for higher rates of stroke or death in patients with hostile neck anatomy. After adjusting for potential confounders, there were no differences in technical failure (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 0.59-2.21; P = .699), stroke (aOR, 0.86; 95% CI, 0.58-1.28; P = .464), death (aOR, 0.82; 95% CI, 0.39-1.71; P = .598), and MI (aOR, 1.18; 95% CI, 0.71-1.97; P = .518). However, patients with hostile neck were at a 30% increased risk of access site complications (aOR, 1.30; 95% CI, 1.0-1.6; P = .023). Further adjusted analysis comparing the outcomes in TFCAS and TCAR among patients with hostile neck anatomy showed an almost four-fold increase in risk of death (aOR, 3.77; 95% CI, 1.49-9.53; P = .005) and technical failure (aOR, 3.69; 95% CI, 1.82-7.47; P < .001) among patients undergoing treatment with TFCAS. CONCLUSIONS: Patients with a hostile neck anatomy undergoing TCAR experienced an increased risk of access site complications; however, the risk for technical failure and postoperative stroke/death, stroke, TIA, MI, or death was similar among both groups. TFCAS was associated with significant increase in the risk of death and technical failure compared with TCAR in this group of patients. These results confirm that TCAR should be the preferred minimally invasive revascularization procedure for patients with hostile neck anatomy.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.

OBJECTIVE: Current guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). METHODS: We identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. RESULTS: Of the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. CONCLUSIONS: Compared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

Vascular Quality Initiative assessment of compliance with Society for Vascular Surgery clinical practice guidelines on the management of extracranial cerebrovascular disease.

OBJECTIVES: Compliance with Society for Vascular Surgery (SVS) clinical practice guidelines (CPGs) is associated with improved outcomes for the treatment of abdominal aortic aneurysm, but this has not been assessed for carotid artery disease. The Vascular Quality Initiative (VQI) registry was used to examine compliance with the SVS CPGs for the management of extracranial cerebrovascular disease and its impact on outcomes. METHODS: The 2021 SVS extracranial cerebrovascular disease CPGs were reviewed for evaluation by VQI data. Compliance rates by the center and provider were calculated, and the impact of compliance on outcomes was assessed using logistic regression with inverse probability-weighted risk adjustment for each CPG recommendation, allowing for clustering by the center. Our primary outcome was a composite end point of in-hospital stroke/death. As a secondary analysis, compliance with the 2021 SVS carotid implementation document recommendations and associated outcomes were also assessed. RESULTS: Of the 11 carotid CPG recommendations, 4 (36%) could be evaluated using VQI registry data. Median center-specific CPG compliance ranged from 38% to 95%, and median provider-specific compliance ranged from 36% to 100%. After adjustment, compliance with 2 of the recommendations was associated with lower rates of in-hospital stroke/death: first, the use of best medical therapy (antiplatelet and statin therapy) in low/standard surgical risk patients undergoing carotid endarterectomy for >70% asymptomatic stenosis (event rate in compliant vs noncompliant cases 0.59% vs 1.3%; adjusted odds ratio: 0.44, 95% confidence interval: 0.29-0.66); and second, carotid endarterectomy over transfemoral carotid artery stenting in low/standard surgical risk patients with >50% symptomatic stenosis (1.9% vs 3.4%; adjusted odds ratio: 0.55, 95% confidence interval: 0.43-0.71). Of the 132 implementation document recommendations, only 10 (7.6%) could be assessed using VQI data, with median center- and provider-specific compliance rates ranging from 67% to 100%. The impact of compliance on outcomes could only be assessed for 6 (4.5%) of these recommendations, and compliance with all 6 recommendations was associated with lower stroke/death. CONCLUSIONS: Few SVS recommendations could be assessed in the VQI because of incongruity between the recommendations and the VQI data variables collected. Although guideline compliance was extremely variable among VQI centers and providers, compliance with most of these recommendations was associated with improved outcomes after carotid revascularization. This finding confirms the value of guideline compliance, which should be encouraged for centers and providers. Optimization of VQI data to promote evaluation of guideline compliance and distribution of these findings to VQI centers and providers will help facilitate quality improvement efforts in the care of vascular patients.

Efficacy and safety of perioperative dual antiplatelet therapy with ticagrelor versus clopidogrel in carotid artery stenting.

BACKGROUND: Clopidogrel resistance is associated with increased periprocedural neurologic events after carotid artery stenting (CAS). Ticagrelor offers an improved resistance profile; however, its bleeding risk has not been assessed with CAS. Therefore, we examined the efficacy and safety of perioperative dual antiplatelet therapy with aspirin/ticagrelor vs aspirin/clopidogrel in patients undergoing transfemoral carotid artery stenting (tfCAS) or transcarotid artery revascularization (TCAR). METHODS: We identified all patients who underwent tfCAS or TCAR in the Vascular Quality Initiative registry from January 2016 to March 2021. We stratified patients by procedure and assessed outcomes using 1:3 propensity score-matched cohorts of patients who received perioperative aspirin/ticagrelor vs aspirin/clopidogrel. The primary efficacy outcome was a composite endpoint of in-hospital stroke/death, and the primary safety outcome was access-related bleeding. As a secondary analysis, we assessed these outcomes after stratifying each cohort by intraoperative protamine use. RESULTS: Among 17,731 tfCAS patients, 593 (3.3%) received aspirin/ticagrelor and 11,404 (64%) received aspirin/clopidogrel. For the 2065 matched patients, no significant differences were found in the composite endpoint of stroke/death (aspirin/ticagrelor, 4.1%; vs aspirin/clopidogrel, 2.6%; relative risk [RR],1.5; 95% confidence interval [CI], 0.88-2.7) or in the individual endpoints of stroke (2.9% vs 1.8%; RR, 1.6; 95% CI, 0.87-3.0) or death (1.7% vs 1.1%; RR, 1.6; 95% CI, 0.71-3.5). However, aspirin/ticagrelor was associated with a higher risk of bleeding (5.8% vs 2.8%; RR, 2.0; 95% CI, 1.2-3.2). In a subgroup analysis of 297 tfCAS patients (14%) who received intraoperative protamine, no differences remained in stroke/death (1.5% vs 3.9%; RR, 0.38; 95% CI, 0.05-3.0), and there was no longer a difference in bleeding (3.0% vs 2.6%; RR, 1.1; 95% CI, 0.24-5.5). Among 17,946 TCAR patients, 453 (2.5%) received aspirin/ticagrelor and 13,696 (76%) received aspirin/clopidogrel. For the 1618 matched patients, no differences were found in stroke/death (0.7% vs 1.4%; RR, 0.53; 95% CI, 0.16-1.8), stroke (0.2% vs 1.2%; RR, 0.20; 95% CI, 0.03-1.5), death (0.5% vs 0.2%; RR, 3.0; 95% CI, 0.42-21), or bleeding (1.2% vs 1.6%; RR, 0.75; 95% CI, 0.28-2.0). For the 1429 TCAR patients (88%) who received protamine, no differences were found in stroke/death (0.8% vs 1.2%; RR, 0.68; 95% CI, 0.20-2.4) or bleeding (0.6% vs 1.4%; RR, 0.39; 95% CI, 0.09-1.7). CONCLUSIONS: Compared with aspirin/clopidogrel, aspirin/ticagrelor was associated with a potentially lower risk of stroke/death and bleeding complications after CAS in cases in which protamine was used but a higher risk of these outcomes in the absence of protamine. Given our limited sample size, our analysis should be repeated when more patients are available for study. However, our findings suggest that aspirin/ticagrelor could be a reasonable alternative to aspirin/clopidogrel for both tfCAS and TCAR when protamine is used.

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality. METHODS: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes. RESULTS: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality. CONCLUSIONS: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.

Procedural Safety Comparison Between Transcarotid Artery Revascularization, Carotid Endarterectomy, and Carotid Stenting: Perioperative and 1-Year Rates of Stroke or Death.

Background Transcarotid artery revascularization (TCAR) was approved by the Food and Drug Administration in 2015 for patients with carotid artery stenosis. However, no randomized trial to evaluate TCAR has been performed to date, and previous reports have important limitations. Accordingly, we measured stroke or death after TCAR compared with carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). Methods and Results We used the Vascular Quality Initiative registry to study patients who underwent TCAR, CEA, or TF-CAS from September 2016 to June 2021. Our primary outcomes were perioperative and 1-year stroke or death. We used logistic regression for risk adjustment for perioperative outcomes and Cox regression for risk adjustment for 1-year outcomes. We used a 2-stage residual inclusion instrumental variable (IV) method to adjust for selection bias and other unmeasured confounding. Our instrument was a center's preference to perform TCAR versus CEA or TF-CAS. We performed a subgroup analysis stratified by presenting neurologic symptoms. We studied 21 234 patients who underwent TCAR, 82 737 who underwent CEA, and 14 595 who underwent TF-CAS across 662 centers. The perioperative rate of stroke or death was 2.0% for TCAR, 1.7% for CEA, and 3.7% for TF-CAS (P<0.001). Compared with TCAR, the IV-adjusted odds ratio of perioperative stroke or death for CEA was 0.74 (95% CI, 0.55-0.99) and for TF-CAS was 1.66 (95% CI, 0.99-2.79). Results were similar among both symptomatic and asymptomatic patients. The 1-year rate of stroke or death was 6.4% for TCAR, 5.2% for CEA, and 9.7% for TF-CAS (P<0.001). Compared with TCAR, the IV-adjusted hazard ratio of 1 year stroke or death for CEA was 0.97 (95% CI, 0.80-1.17), and for TF-CAS was 1.45 (95% CI, 1.04-2.02). IV analysis further demonstrated that symptomatic patients with carotid stenosis had the lowest 1-year likelihood of stroke or death with TCAR (compared with TCAR, symptomatic IV-adjusted hazard ratio for CEA: 1.30 [95% CI, 1.04-1.64], and TF-CAS: 1.86 [95% CI, 1.27-2.71]). Conclusions Perioperative stroke or death was greater following TCAR when compared with CEA. However, at 1 year there was no statistically significant difference in stroke or death between the 2 procedures. TCAR performed favorably compared with TF-CAS at both time points. Although CEA remains the gold standard procedure for patients with carotid stenosis, TCAR appears to be a safe alternative to CEA and TF-CAS when used selectively and may be useful when treating symptomatic patients.