Study Summary
This trial will compare the outcomes of women who receive one arterial graft during CABG surgery (SAG) to those who receive multiple arterial grafts (MAG).
Eligible Conditions
- Coronary Artery Disease
- Coronary Artery Bypass Surgery
- Heart Diseases
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 18 Secondary · Reporting Duration: > 48 hours postoperatively, minimum 2.5 year follow-up
Year 12
Cause-specific death (cardiac vs non-cardiac)
Major post-operative complications such as bleeding, stroke, surgical site complication
Sternal wound complications
Stroke, post discharge myocardial infarction and repeat revascularization considered as individual events
Year 12
Hospital readmissions with specific causes
30-day mortality
Mortality
Year 5
Myocardial Infarction
Hour 72
Death from any cause, any stroke, myocardial infarction
Year 5
Death from any cause
Cerebral Revascularization
Cerebral Revascularization
Generic quality of life according to EuroQuol-5D (EQ-5D)
Generic quality of life according to the Short Form Health Survey (SF-12v2)
Generic quality of life, mental and physical health symptoms
Mental and physical health symptoms according to PROMIS instruments
Acute Coronary Syndrome
Heart failure
Repeat revascularization
Cerebrovascular accident
Cerebral Revascularization
Disease
Day 30
Other recorded outcomes (safety endpoints)
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Multiple Arterial Graft (MAG) group
1 of 4
Single Arterial Graft (SAG) group
1 of 4
Single Arterial Group
1 of 4
Multiple Arterial Group
1 of 4
Experimental Treatment
2000 Total Participants · 4 Treatment Groups
Primary Treatment: Procedure: Multiple arterial grafting · No Placebo Group · N/A
Multiple Arterial Graft (MAG) group
Procedure
Experimental Group · 1 Intervention: Multiple arterial grafting · Intervention Types: ProcedureSingle Arterial Graft (SAG) group
Procedure
Experimental Group · 1 Intervention: Single arterial graft · Intervention Types: ProcedureSingle Arterial Group
Procedure
Experimental Group · 1 Intervention: Procedure: Single arterial graft · Intervention Types: ProcedureMultiple Arterial Group
Procedure
Experimental Group · 1 Intervention: Procedure: Multiple arterial grafting · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: > 48 hours postoperatively, minimum 2.5 year follow-up
Who is running the clinical trial?
Oxford University Hospitals NHS TrustOTHER
194 Previous Clinical Trials
2,013,687 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
23,876 Patients Enrolled for Coronary Artery Disease
University of GöttingenOTHER
62 Previous Clinical Trials
28,852 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
1,121 Patients Enrolled for Coronary Artery Disease
Maastricht University Medical CenterLead Sponsor
853 Previous Clinical Trials
3,535,217 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
11,565 Patients Enrolled for Coronary Artery Disease
Columbia UniversityOTHER
1,284 Previous Clinical Trials
1,611,524 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
12,514 Patients Enrolled for Coronary Artery Disease
New York Presbyterian HospitalOTHER
70 Previous Clinical Trials
28,141 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
452 Previous Clinical Trials
142,172 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
15,623 Patients Enrolled for Coronary Artery Disease
Sunnybrook Health Sciences CentreOTHER
599 Previous Clinical Trials
1,466,416 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
2,197 Patients Enrolled for Coronary Artery Disease
Weill Medical College of Cornell UniversityLead Sponsor
983 Previous Clinical Trials
1,336,452 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
41,993 Patients Enrolled for Coronary Artery Disease
Duke UniversityOTHER
2,159 Previous Clinical Trials
3,186,578 Total Patients Enrolled
16 Trials studying Coronary Artery Disease
48,117 Patients Enrolled for Coronary Artery Disease
Roberto Lorusso, Prof/PhD/MDPrincipal InvestigatorMaastricht University Medical Centre, Maastricht, The Netherlands
David Taggart, Prof/PhD/MDPrincipal InvestigatorJohn Radcliffe Hospital, Oxford, United Kingdom
Ingo Kutschka, Prof/PhD/MDPrincipal InvestigatorUniversitätsmedizin Göttingen, Göttingen Germany
Mario Gaudino, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
4,300 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
4,300 Patients Enrolled for Coronary Artery Disease
Mario Gaudino, Prof/PhD/MDPrincipal InvestigatorWeill Medical College of Cornell University
Ruth Masterson Creber, RN, PhDPrincipal InvestigatorColumbia University
C. Noel Bairey Merz, MDPrincipal InvestigatorCedars-Sinai
8 Previous Clinical Trials
1,148 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
179 Patients Enrolled for Coronary Artery Disease
Karla Ballman, PhDPrincipal InvestigatorWeill Medical College of Cornell University
Stephen Fremes, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
4,565 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
4,565 Patients Enrolled for Coronary Artery Disease
Sean O'Brien, PhDPrincipal InvestigatorDuke University
Eligibility Criteria
Age 18+ · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 12th, 2021
Last Reviewed: November 21st, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Lytle, Bruce W., Eugene H. Blackstone, Floyd D. Loop, Penny L. Houghtaling, John H. Arnold, Rami Akhrass, Patrick M. McCarthy, and Delos M. Cosgrove. 1999. “Two Internal Thoracic Artery Grafts Are Better Than One”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/s0022-5223(99)70365-x.
- Hillis, L. David, Peter K. Smith, Jeffrey L. Anderson, John A. Bittl, Charles R. Bridges, John G. Byrne, Joaquin E. Cigarroa, et al.. 2011. “2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2011.08.009.
- Tatoulis, James, Brian F Buxton, and John A Fuller. 2004. “Patencies of 2,127 Arterial to Coronary Conduits over 15 Years”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/s0003-4975(03)01331-6.
- Benedetto, U., S. G. Raja, A. Albanese, M. Amrani, G. Biondi-Zoccai, and G. Frati. 2014. “Searching for the Second Best Graft for Coronary Artery Bypass Surgery: A Network Meta-analysis of Randomized Controlled Trials”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezu111.
- “2014 ESC/EACTS Guidelines on Myocardial Revascularization”. 2014. “2014 ESC/EACTS Guidelines on Myocardial Revascularization”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehu278.
- Loop, Floyd D., Bruce W. Lytle, Delos M. Cosgrove, Robert W. Stewart, Marlene Goormastic, George W. Williams, Leonard A.R. Golding, et al.. 1986. “Influence of the Internal-mammary-artery Graft on 10-year Survival and Other Cardiac Events”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm198601023140101.
- Yi, Gijong, Brian Shine, Syed M. Rehman, Douglas G. Altman, and David P. Taggart. 2014. “Effect of Bilateral Internal Mammary Artery Grafts on Long-term Survival”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.004255.
- Taggart, David P, Roberto D'Amico, and Douglas G Altman. 2001. “Effect of Arterial Revascularisation on Survival: A Systematic Review of Studies Comparing Bilateral and Single Internal Mammary Arteries”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(01)06069-x.
- Aldea, Gabriel S., Faisal G. Bakaeen, Jay Pal, Stephen Fremes, Stuart J. Head, Joseph Sabik, Todd Rosengart, et al.. 2016. “The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.09.100.
- Loop, Floyd D., Bruce W. Lytle, Delos M. Cosgrove, Robert W. Stewart, Marlene Goormastic, George W. Williams, Leonard A.R. Golding, et al.. 1986. “Influence of the Internal-mammary-artery Graft on 10-year Survival and Other Cardiac Events”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm198601023140101.
- Benedetto, U., S. G. Raja, A. Albanese, M. Amrani, G. Biondi-Zoccai, and G. Frati. 2014. “Searching for the Second Best Graft for Coronary Artery Bypass Surgery: A Network Meta-analysis of Randomized Controlled Trials”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezu111.
- Taggart, David P, Roberto D'Amico, and Douglas G Altman. 2001. “Effect of Arterial Revascularisation on Survival: A Systematic Review of Studies Comparing Bilateral and Single Internal Mammary Arteries”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(01)06069-x.
- Yi, Gijong, Brian Shine, Syed M. Rehman, Douglas G. Altman, and David P. Taggart. 2014. “Effect of Bilateral Internal Mammary Artery Grafts on Long-term Survival”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.004255.
- “2014 ESC/EACTS Guidelines on Myocardial Revascularization”. 2014. “2014 ESC/EACTS Guidelines on Myocardial Revascularization”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehu278.
- Lytle, Bruce W., Eugene H. Blackstone, Floyd D. Loop, Penny L. Houghtaling, John H. Arnold, Rami Akhrass, Patrick M. McCarthy, and Delos M. Cosgrove. 1999. “Two Internal Thoracic Artery Grafts Are Better Than One”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/s0022-5223(99)70365-x.
- Aldea, Gabriel S., Faisal G. Bakaeen, Jay Pal, Stephen Fremes, Stuart J. Head, Joseph Sabik, Todd Rosengart, et al.. 2016. “The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.09.100.
- Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7.
- Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.
- Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.
- Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
- Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.
- Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.
- Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
- Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
- 2023. "Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04124120.
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