Transcarotid artery revascularization versus transfemoral carotid artery stenting in the Society for Vascular Surgery Vascular Quality Initiative

Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial...

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Published inJournal of vascular surgery Vol. 69; no. 1; pp. 92 - 103.e2
Main Authors Malas, Mahmoud B., Dakour-Aridi, Hanaa, Wang, Grace J., Kashyap, Vikram S., Motaganahalli, Raghu L., Eldrup-Jorgensen, Jens, Cronenwett, Jack L., Schermerhorn, Marc L.
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.01.2019
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Abstract Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results. Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial. [Display omitted]
AbstractList Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI).BACKGROUNDRecent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI).The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure.METHODSThe Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure.Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results.RESULTSCompared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results.Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.CONCLUSIONSCompared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.
Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results. Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.
AbstractBackgroundRecent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). MethodsThe Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. ResultsCompared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [ P = .04] and 3.8% vs 2.2% [ P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [ P = .06]; TFCAS, 5.3% vs 2.7% [ P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results. ConclusionsCompared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.
Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results. Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial. [Display omitted]
Author Schermerhorn, Marc L.
Malas, Mahmoud B.
Dakour-Aridi, Hanaa
Motaganahalli, Raghu L.
Eldrup-Jorgensen, Jens
Kashyap, Vikram S.
Cronenwett, Jack L.
Wang, Grace J.
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  givenname: Mahmoud B.
  surname: Malas
  fullname: Malas, Mahmoud B.
  email: bmalas1@jhmi.edu
  organization: Johns Hopkins Bayview Vascular and Endovascular Research Center, Baltimore, Md
– sequence: 2
  givenname: Hanaa
  surname: Dakour-Aridi
  fullname: Dakour-Aridi, Hanaa
  organization: Johns Hopkins Bayview Vascular and Endovascular Research Center, Baltimore, Md
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  givenname: Grace J.
  surname: Wang
  fullname: Wang, Grace J.
  organization: Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania, Philadelphia, Pa
– sequence: 4
  givenname: Vikram S.
  surname: Kashyap
  fullname: Kashyap, Vikram S.
  organization: Division of Vascular Surgery and Endovascular Therapy, University Hospitals Cleveland Medical Center, Cleveland, Ohio
– sequence: 5
  givenname: Raghu L.
  surname: Motaganahalli
  fullname: Motaganahalli, Raghu L.
  organization: Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind
– sequence: 6
  givenname: Jens
  surname: Eldrup-Jorgensen
  fullname: Eldrup-Jorgensen, Jens
  organization: Division of Vascular Surgery and Endovascular Therapy, Maine Medical Center, Portland, Me
– sequence: 7
  givenname: Jack L.
  surname: Cronenwett
  fullname: Cronenwett, Jack L.
  organization: Section of Vascular Surgery and The Dartmouth Institute, Dartmouth-Hitchcock Medical Center, Lebanon, NH
– sequence: 8
  givenname: Marc L.
  surname: Schermerhorn
  fullname: Schermerhorn, Marc L.
  organization: Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass
BackLink https://www.ncbi.nlm.nih.gov/pubmed/29941316$$D View this record in MEDLINE/PubMed
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Issue 1
Keywords Transfemoral
Transcarotid
Carotid artery stenting
Vascular Quality Initiative
TCAR Surveillance Project
Language English
License This article is made available under the Elsevier license.
Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
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Snippet Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk...
AbstractBackgroundRecent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter...
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SubjectTerms Aged
Aged, 80 and over
Carotid artery stenting
Carotid Stenosis - complications
Carotid Stenosis - diagnostic imaging
Carotid Stenosis - mortality
Carotid Stenosis - surgery
Catheterization, Peripheral - adverse effects
Catheterization, Peripheral - mortality
Endovascular Procedures - adverse effects
Endovascular Procedures - instrumentation
Endovascular Procedures - mortality
Female
Femoral Artery - diagnostic imaging
Hospital Mortality
Humans
Ischemic Attack, Transient - etiology
Ischemic Attack, Transient - mortality
Male
Middle Aged
Punctures
Registries
Retrospective Studies
Risk Factors
Stents
Stroke - etiology
Stroke - mortality
Surgery
TCAR Surveillance Project
Time Factors
Transcarotid
Transfemoral
Treatment Outcome
United States
Vascular Quality Initiative
Vascular Surgical Procedures - adverse effects
Vascular Surgical Procedures - instrumentation
Vascular Surgical Procedures - mortality
Title Transcarotid artery revascularization versus transfemoral carotid artery stenting in the Society for Vascular Surgery Vascular Quality Initiative
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https://dx.doi.org/10.1016/j.jvs.2018.05.011
https://www.ncbi.nlm.nih.gov/pubmed/29941316
https://www.proquest.com/docview/2059562248
Volume 69
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