Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL)
Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether rout...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-12-01
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| Series: | CJC Open |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589790X22001676 |
| _version_ | 1828167819122966528 |
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| author | Sulaiman Alrashidi, MD Marc-André d’Entremont, MD, MPH Omar Alansari, MD Jose Winter, MD Bradley Brochu, MD Laura Heenan, MSc Elizabeth Skuriat, MSc Jessica Tyrwhitt, BSc Michael Raco, MD Michael B. Tsang, MD, MSc Nicholas Valettas, MD, MASc James Velianou, MD Tej Sheth, MD Matthew Sibbald, MD, Ph.D Shamir R. Mehta, MD, MSc Natalia Pinilla-Echeverri, MD, MSc Jon David Schwalm, MD, MSc Madhu K. Natarajan, MD, MSc Andrew Kelly, MD Elie Akl, MD Sarah Tawadros, MBBCh Mercedes Camargo, MD, MASc Walaa Faidi, MSc Gustavo Dutra, MD Sanjit S. Jolly, MD, MSc |
| author_facet | Sulaiman Alrashidi, MD Marc-André d’Entremont, MD, MPH Omar Alansari, MD Jose Winter, MD Bradley Brochu, MD Laura Heenan, MSc Elizabeth Skuriat, MSc Jessica Tyrwhitt, BSc Michael Raco, MD Michael B. Tsang, MD, MSc Nicholas Valettas, MD, MASc James Velianou, MD Tej Sheth, MD Matthew Sibbald, MD, Ph.D Shamir R. Mehta, MD, MSc Natalia Pinilla-Echeverri, MD, MSc Jon David Schwalm, MD, MSc Madhu K. Natarajan, MD, MSc Andrew Kelly, MD Elie Akl, MD Sarah Tawadros, MBBCh Mercedes Camargo, MD, MASc Walaa Faidi, MSc Gustavo Dutra, MD Sanjit S. Jolly, MD, MSc |
| author_sort | Sulaiman Alrashidi, MD |
| collection | DOAJ |
| description | Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%. Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease. Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide. Résumé: Introduction: Par rapport à l’abord radial, la limitation importante de l’abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L’abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l’utilisation systématique du guidage par US pour l’abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le Bleeding Academic Research Consortium (BARC) ou les complications vasculaires majeures. Méthodes: L’Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l’insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l’abord fémoral guidé par US ou sans US. Le principal critère d’évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L’essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d’évaluation principal selon un taux d’événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L’essai UNIVERSAL qui sera l’un des plus vastes essais à répartition aléatoire sur l’abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier. |
| first_indexed | 2024-04-12T02:23:37Z |
| format | Article |
| id | doaj.art-c0526a8e4a6f4ae08887bc366378060b |
| institution | Directory Open Access Journal |
| issn | 2589-790X |
| language | English |
| last_indexed | 2024-04-12T02:23:37Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | CJC Open |
| spelling | doaj.art-c0526a8e4a6f4ae08887bc366378060b2022-12-22T03:52:04ZengElsevierCJC Open2589-790X2022-12-0141210741080Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL)Sulaiman Alrashidi, MD0Marc-André d’Entremont, MD, MPH1Omar Alansari, MD2Jose Winter, MD3Bradley Brochu, MD4Laura Heenan, MSc5Elizabeth Skuriat, MSc6Jessica Tyrwhitt, BSc7Michael Raco, MD8Michael B. Tsang, MD, MSc9Nicholas Valettas, MD, MASc10James Velianou, MD11Tej Sheth, MD12Matthew Sibbald, MD, Ph.D13Shamir R. Mehta, MD, MSc14Natalia Pinilla-Echeverri, MD, MSc15Jon David Schwalm, MD, MSc16Madhu K. Natarajan, MD, MSc17Andrew Kelly, MD18Elie Akl, MD19Sarah Tawadros, MBBCh20Mercedes Camargo, MD, MASc21Walaa Faidi, MSc22Gustavo Dutra, MD23Sanjit S. Jolly, MD, MSc24McMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaPopulation Health Research Institute, Hamilton, Ontario, Canada; Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaClinica Alemana de Santiago, Santiago, ChileCK Hui Heart Centre, Royal Alexandra Hospital, Edmonton, Alberta, CanadaPopulation Health Research Institute, Hamilton, Ontario, CanadaPopulation Health Research Institute, Hamilton, Ontario, CanadaPopulation Health Research Institute, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, CanadaMcGill University Health Centre, Montreal, Quebec, CanadaHamilton Health Sciences, Hamilton, Ontario, CanadaHamilton Health Sciences, Hamilton, Ontario, CanadaHamilton Health Sciences, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, CanadaMcMaster University, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Niagara Health, St. Catharines, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada; Corresponding author: Dr Sanjit S. Jolly, Population Health Research Institute, Hamilton General Hospital, 237 Barton St. East, Hamilton, Ontario L8L 2X2, Canada. Tel.: +1-905-521-2100 ext. 40309.Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%. Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease. Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide. Résumé: Introduction: Par rapport à l’abord radial, la limitation importante de l’abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L’abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l’utilisation systématique du guidage par US pour l’abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le Bleeding Academic Research Consortium (BARC) ou les complications vasculaires majeures. Méthodes: L’Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l’insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l’abord fémoral guidé par US ou sans US. Le principal critère d’évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L’essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d’évaluation principal selon un taux d’événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L’essai UNIVERSAL qui sera l’un des plus vastes essais à répartition aléatoire sur l’abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.http://www.sciencedirect.com/science/article/pii/S2589790X22001676 |
| spellingShingle | Sulaiman Alrashidi, MD Marc-André d’Entremont, MD, MPH Omar Alansari, MD Jose Winter, MD Bradley Brochu, MD Laura Heenan, MSc Elizabeth Skuriat, MSc Jessica Tyrwhitt, BSc Michael Raco, MD Michael B. Tsang, MD, MSc Nicholas Valettas, MD, MASc James Velianou, MD Tej Sheth, MD Matthew Sibbald, MD, Ph.D Shamir R. Mehta, MD, MSc Natalia Pinilla-Echeverri, MD, MSc Jon David Schwalm, MD, MSc Madhu K. Natarajan, MD, MSc Andrew Kelly, MD Elie Akl, MD Sarah Tawadros, MBBCh Mercedes Camargo, MD, MASc Walaa Faidi, MSc Gustavo Dutra, MD Sanjit S. Jolly, MD, MSc Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL) CJC Open |
| title | Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL) |
| title_full | Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL) |
| title_fullStr | Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL) |
| title_full_unstemmed | Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL) |
| title_short | Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL) |
| title_sort | design and rationale of routine ultrasound guidance for vascular access for cardiac procedures a randomized trial universal |
| url | http://www.sciencedirect.com/science/article/pii/S2589790X22001676 |
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