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.

Effect of Postoperative Stroke Timing on Perioperative Mortality After Carotid Revascularization.

BACKGROUND: In-hospital stroke (IHS) has been associated with worse outcomes than out-of-hospital stroke (OHS) due to delays in diagnosis and treatment. A paucity of studies exists comparing the timing of postoperative stroke after carotid revascularization. We aimed to study the effect of IHS versus OHS on postoperative mortality in carotid revascularization patients in a large-scale national database. METHODS: This is a retrospective cohort study of patients who underwent carotid artery stenting (CAS) and carotid endarterectomy (CEA) between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Statistical analysis included chi-squared test and multivariable logistic regression. Patients were divided based on postoperative stroke timing (no stroke, IHS, or OHS) as well as procedure type (CEA or CAS). RESULTS: A total of 31,304 carotid revascularizations were performed with 420 (1.3%) IHSs and 207 (0.7%) OHSs. On adjusted analysis, there was significantly higher perioperative mortality with both IHS [odds ratio (OR): 19.75, 95% confidence interval (CI): 13.61-28.18, P < 0.001] and OHS [OR: 29.73, 95% CI: 18.76-45.82, P < 0.001]. There was no difference in mortality after OHS versus IHS [OR: 1.51, 95% CI: 0.89-2.55, P = 0.161]. CONCLUSIONS: Any postoperative stroke after carotid revascularization significantly increased the odds of 30-day mortality. In contrast to previous studies demonstrating worse outcomes after IHS than OHS, we observed similar 30-day mortality between the 2 stroke categories. Improved follow-up and early recognition with rescue within carotid revascularization patients compared to the general population could potentially contribute to these results. However, overall mortality remains high for any postoperative stroke following carotid revascularization, emphasizing the importance of vigilant in-hospital monitoring and follow-up even after discharging the patient.

Preoperative Spinal Drain Placement is Associated with Reduced Risk of Spinal Cord Ischemia in Patients Undergoing Thoracic Endovascular Aortic Repair for Aortic Dissection.

BACKGROUND: Spinal cord ischemia (SCI) is a rare but serious complication of Thoracic Endovascular Aortic Repair (TEVAR). Several measures including spinal drain (SD) placement have been proposed to reduce the risk of SCI in TEVARs performed for aneurysms. However, there are no specific large-scale data on potential benefits of SD placement in Stanford Type B aortic dissection (TBAD). We aimed to assess the impact of preoperative SD placement on preventing SCI during TEVARs performed for TBAD. METHODS: We included all TEVAR cases performed for TBAD in Vascular Quality Initiative (VQI) from 2012 to 2021. Patients with connective tissue disease, open conversion, rupture, proximal disease > zone 5, proximal landing zone <2 or SCI on presentation were excluded. One-to-one propensity score matching was used to balance patients on 34 dimensions by the nearest neighbor principle to compare patients based on preoperative SD placement. The primary outcome was SCI. Secondary outcomes included 30-day and 90-day mortality, perioperative complications, and 90-day2intervention. RESULTS: A total of 2,683 TEVARs were performed for TBAD with 1,227 (45.7%) undergoing preoperative SD placement. Propensity matching produced 672 well-matched pairs. In the matched cohort, SD placement was not associated with significant reduction in temporary SCI (3.0% vs. 3.7%, P = 0.45). However, SD placement was associated with significant reduction of the risk of permanent SCI at discharge (1.3% vs. 3.4%, P = 0.012). SD was also associated with lower risk of 30-day mortality (3.7% vs 6.4%, P = 0.025) and shorter length of stay but not 90-day mortality or 90-day reintervention. CONCLUSIONS: Our study suggests that preoperative SD placement in patients undergoing TEVAR for TBAD is beneficial in reducing the risk of permanent SCI without increasing risks of perioperative complications. Further prospective studies are necessary to confirm these findings.

In-Hospital Outcomes of Urgent, Early, or Late Revascularization for Symptomatic Carotid Artery Stenosis.

BACKGROUND AND PURPOSE: Advancements in carotid revascularization have produced promising outcomes in patients with symptomatic carotid artery stenosis. However, the optimal timing of revascularization procedures after symptomatic presentation remains unclear. The purpose of this study is to compare in-hospital outcomes of transcarotid artery revascularization (TCAR), transfemoral carotid stenting (TFCAS), or carotid endarterectomy (CEA) performed within different time intervals after most recent symptoms. METHODS: This is a retrospective cohort study of United States patients in the vascular quality initiative. All carotid revascularizations performed for symptomatic carotid artery stenosis between September 2016 and November 2019 were included. Procedures were categorized as urgent (0-2 days after most recent symptom), early (3-14 days), or late (15-180 days). The primary outcome of interest was in-hospital stroke and death. Secondary outcomes include in-hospital stroke, death, and transient ischemic attacks. Multivariable logistic regression was used to compare outcomes. RESULTS: A total of 18 643 revascularizations were included: 2006 (10.8%) urgent, 7423 (39.8%) early, and 9214 (49.42%) late. Patients with TFCAS had the highest rates of stroke/death at all timing cohorts (urgent: 4.0% CEA, 6.9% TFCAS, 6.5% TCAR, P=0.018; early: 2.5% CEA, 3.8% TFCAS, 2.9% TCAR, P=0.054; late: 1.6% CEA, 2.8% TFCAS, 2.3% TCAR, P=0.003). TFCAS also had increased odds of in-hospital stroke/death compared with CEA in all 3 groups (urgent adjusted odds ratio [aOR], 1.7 [95% CI, 1.0-2.9] P=0.03; early aOR, 1.6 [95% CI, 1.1-2.4] P=0.01; and late aOR, 1.9 [95% CI, 1.2-3.0] P=0.01). TCAR and CEA had comparable odds of in-hospital stroke/death in all 3 groups (urgent aOR, 1.9 [95% CI, 0.9-4], P=0.10), (early aOR, 1.1 [95% CI, 0.7-1.7], P=0.66), (late aOR, 1.5 [95% CI, 0.9-2.3], P=0.08). CONCLUSIONS: CEA remains the safest method of revascularization within the urgent period. Among revascularization performed outside of the 48 hours, TCAR and CEA have comparable outcomes.

In-hospital complications and long-term outcomes associated with timing of carotid endarterectomy.

OBJECTIVE: Carotid revascularization performed within 2 weeks of symptoms has proven to reduce risk of recurrent stroke in patients with symptomatic carotid artery stenosis. However, the optimal timing of revascularization within the 2-week window has yet to be determined. The objective of this study was to perform a comprehensive analysis of in-hospital and long-term outcomes of carotid endarterectomy (CEA) performed within different time intervals after most recent symptoms. METHODS: We analyzed 2003 to 2016 data from the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network. Only revascularizations performed for symptomatic carotid artery stenosis were included. Procedures were categorized as urgent (0-2 days from latest symptom), early (3-14 days), or late (15-180 days). The primary in-hospital outcome was stroke/death. The primary long-term outcomes of interest were 5-year recurrent ipsilateral stroke/death. Multivariable logistic regression, Kaplan-Meier analysis, and Cox regression were utilized to compare outcomes. RESULTS: A total of 18,970 revascularizations were included: 1130 (6.0%) urgent, 4643 (24.5%) early, and 13,197 (69.6%) late. Earlier CEA had increased odds of in-hospital stroke/death compared with late CEA (urgent: adjusted odds ratio, 1.9; 95% confidence interval [CI], 1.3-2.8; P = .001; early: adjusted odds ratio, 1.7; 95% CI, 1.3-2.2; P < .001). No differences were seen in 5-year risk of stroke/death (urgent: adjusted hazard ratio, 0.95; 95% CI, 0.79-1.15; P = .592; early: adjusted hazard ratio, 0.97; 95% CI, 0.87-1.07; P = .928). CONCLUSIONS: Urgent and early CEA were associated with increased perioperative risk without difference in 5-year outcomes compared with late CEA. Short-term recurrent stroke prevention could not be assessed. Updated population-based studies comparing recurrent stroke prevention with urgent or early revascularization vs best medical management are warranted.

The impact of carotid lesion calcification on outcomes of carotid artery stenting.

OBJECTIVE: The impact of carotid artery lesion calcification on adverse events following carotid artery stenting is not well-studied. Few reports associated heavily calcified lesions with high risk of perioperative stroke following transfemoral carotid artery stenting (TFCAS). With the advent of transcarotid artery revascularization (TCAR), we aimed to compare the outcomes of these two procedures stratified by the degree of lesion calcification. METHODS: Our cohort was derived from the Vascular Quality Initiative database for carotid artery stenting. Patients with missing information on the degree of carotid artery calcification were excluded. Patients were stratified into two groups: >50% (heavy) calcification and ≤50% (no/mild) calcification. The Student t test and the χ2 test were used to compare patients' baseline characteristics and crude outcomes, as appropriate. Clinically relevant and statistically significantly variables on univariable analysis were added to a logistic regression model clustered by center identifier. RESULTS: A total of 11,342 patients were included. Patients with >50% calcification were older, had more comorbidities, and more contralateral occlusion. There were more patients with prior ipsilateral carotid endarterectomy in the ≤50% calcification group. In patients who underwent TCAR, there were no significant differences between those who had >50% vs ≤50% carotid calcification in the odds of in-hospital adverse outcomes. However, in patients with heavy calcification who underwent TFCAS, there was a 50% to 60% increase in the odds of stroke (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.04-2.5; P = .03), stroke/transient ischemic attack (TIA) (OR, 1.6; 95% CI, 1.1-2.3; P = .013), and stroke/death (OR, 1.5; 95% CI, 1.02-2.08; P = .039). Compared with TFCAS in patients with heavy calcification, TCAR was associated with a 40% to 90% reduction in the odds of contralateral stroke (OR, 0.13; 95% CI, 0.04-0.4; P = .001), contralateral stroke/TIA (OR, 0.3; 95% CI, 0.1-0.87; P = .024), any stroke/TIA (OR, 0.6; 95% CI, 0.38-0.91; P = .02), death (OR, 0.3; 95% CI, 0.13-0.72; P = .006), stroke/death (OR, 0.5; 95% CI, 0.32-0.8; P = .004), and stroke/death/myocardial infarction (OR, 0.58; 95% CI, 0.39-0.87; P = .008). There were no significant differences in the odds of stroke and myocardial infarction. CONCLUSIONS: In this retrospective analysis of patients undergoing TFCAS vs TCAR in the Vascular Quality Initiative database, TCAR demonstrated favorable outcomes compared with TFCAS among patients with calcification greater than 50% of the carotid circumference. Advance burden of carotid artery calcification was associated with worse outcomes in patients undergoing TFCAS but not TCAR. These results are consistent with previously demonstrated superiority of flow reversal compared with distal embolic protection devices. Further research is needed to assess long-term outcomes and confirm the durability of TCAR in heavily calcified lesions.

Propensity score-matched analysis of 1-year outcomes of transcarotid revascularization with dynamic flow reversal, carotid endarterectomy, and transfemoral carotid artery stenting.

OBJECTIVE: Initial studies showed no significant differences in perioperative stroke or death between transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) and lower stroke/death rates after TCAR compared with transfemoral carotid artery stenting (TFCAS). This study focuses on the 1-year outcomes of ipsilateral stroke or death after TCAR, CEA, and TFCAS. METHODS: All patients undergoing TCAR, TFCAS, and CEA between September 2016 and December 2019 were identified in the Vascular Quality Initiative (VQI) database. The latest follow-up was September 3, 2020. One-to-one propensity score-matched analysis was performed for patients with available 1-year follow-up data for TCAR vs CEA and for TCAR vs TFCAS. Kaplan-Meier survival and Cox proportional hazard regression analyses were used to evaluate 1-year ipsilateral stroke or death after the three procedures. RESULTS: A total of 41,548 patients underwent CEA, 5725 patients underwent TCAR, and 6064 patients underwent TFCAS during the study period and had recorded 1-year outcomes. The cohorts were well-matched in terms of baseline demographics and comorbidities. Among 4180 TCAR vs CEA matched pairs of patients, there were no significant differences in 30-day stroke, death, and stroke/death. However, TCAR was associated with a lower risk of 30-day stroke/death/myocardial infarction (2.30% vs 3.25%; relative risk, 0.71; 95% confidence interval [CI], 0.55-0.91; P = .008), driven by a lower risk of myocardial infarction (0.55% vs 1.12%; hazard ratio [HR], 0.49; 95% CI, 0.30-0.81; P = .004). At 1 year, no significant difference was observed in the risk of ipsilateral stroke or death (6.49% vs 5.68%; HR, 1.14; 95% CI, 0.95-1.37; P = .157). Among 4036 matched pairs in the TCAR vs TFCAS group, TCAR was also associated with lower risk of perioperative stroke or death compared with TFCAS (1.83% vs 2.55%; HR, 0.72; 95% CI, 0.54-0.96; P = .027). At 1 year, the risks of ipsilateral stroke or death of TCAR and TFCAS were comparable (6.07% vs 7.07%; HR, 0.85; 95% CI, 0.71-1.01; P = .07). Symptomatic status did not modify the association in TCAR vs CEA. However, asymptomatic patients had favorable outcomes with TCAR vs TFCAS at 1 year (HR, 0.78; 95% CI, 0.62-0.98; P = .033). CONCLUSIONS: In this propensity score-matched analysis, no significant differences in ipsilateral stroke/death-free survival were observed between TCAR and CEA or between TCAR and TFCAS. The advantages of TCAR compared with TFCAS seem to be mainly in the perioperative period, which makes it a suitable minimally invasive option for surgically high-risk patients with carotid artery stenosis. Larger studies, with longer follow-up and data on restenosis, are warranted to confirm the mid- and long-term benefits and durability of TCAR.

Differences in Perioperative Outcomes after Carotid Revascularization between White and Non-white Patients.

BACKGROUND: Racial disparities in carotid endarterectomy (CEA) and carotid artery stenting (CAS) continue to persist. We aimed to provide a large-scale analysis of racial disparities in perioperative outcomes of carotid revascularization in a nationally representative cohort of patients, with sub-analyses stratifying by procedure type and symptomatic status. METHODS: We studied all patients undergoing carotid revascularization between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database. Univariate methods were used to compare patients' demographic and medical characteristics. Multivariable logistic regression analysis was used to compare adjusted perioperative outcomes between white patients (WP) and non-white patients (NWP). Sub-analysis was performed stratifying by method of revascularization and symptomatic status. RESULTS: A total of 31,356 carotid revascularizations were performed in 26,550 (84.7%) white patients and 4,806 (15.3%) non-white patients. On adjusted analysis, NWP had increased odds of stroke (OR:1.2, 95%CI:1.1-1.5, P = 0.0496), unplanned return to the OR (OR:1.4, 95%CI:1.1-1.6, P < 0.001) and restenosis (OR:2.6, 95%CI:1.7-3.9, P < 0.001). On sub-analysis, NWP undergoing CAS had increased odds of stroke/death (OR:2.2, 95%CI:1.1-4.3, P = 0.025), stroke (OR:2.9, 95%CI:1.3-6.0, P = 0.007), and stroke/TIA (OR:2.1, 95%CI:1.0-4.2, P = 0.025). NWP undergoing CEA had increased odds of unplanned return to the OR (OR:1.4, 95%CI:1.2-1.6, P < 0.001) and restenosis (OR:2.7, 95%CI:1.7-4.0, P < 0.001). CONCLUSION: NWP had higher rates of 30-day stroke, driven primarily by higher rates of perioperative stroke/death in NWP undergoing CAS. NWP undergoing CEA did not have higher rates of stroke/death after adjusted analysis, although they had higher rates of unplanned return to OR and restenosis. Upon stratification for symptomatic status, the stroke/death rate between NWP and WP was shown to be non-significant.

Increased mortality with paclitaxel-eluting stents is driven by lesion length.

BACKGROUND: Endovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease. METHODS: A retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed. RESULTS: Of the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients. CONCLUSIONS: Consistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.