Randomized Controlled Trial

. 2019 Jan 10;380(2):132-141.

doi: 10.1056/NEJMoa1812390. Epub 2018 Nov 11.

Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass

Marco A Zenati¹, Deepak L Bhatt¹, Faisal G Bakaeen¹, Eileen M Stock¹, Kousick Biswas¹, J Michael Gaziano¹, Rosemary F Kelly¹, Elaine E Tseng¹, Jerene Bitondo¹, Jacquelyn A Quin¹, G Hossein Almassi¹, Miguel Haime¹, Brack Hattler¹, Ellen DeMatt¹, Alexandra Scrymgeour¹, Grant D Huang¹; REGROUP Trial Investigators

Collaborators, Affiliations

Collaborators

REGROUP Trial Investigators:
Cindy Colling, Jennifer M Gabany, Abbas Ardehali, Ramin Ebrahimi, Victor Ferraris, Ronnie Ramadan, Gail MacCallum, Hill Wolfe, Annette Phillips, Perry Point, Michael Beam, Daniel Briones, Joseph Collins, Christine Dalzell, Jeanie Kim, Annette Wiseman, Timothy J O’Leary, Michael Jessen, William Blackwelder, Thomas Burdon, Frank Harrell, Dominick Mariconda, Wen-Chih Hank Wu, Said Yassin, Alvise Bernabei, Richard Rode, Edward Bates, Micah Geuss, John Lucke, Robert Ferguson, Ronald Hill, Paul Ballard, Michael Nicolini, Mariette Coyle, Valerie Allen, Whitney Sprinkle, Jacquelyn Quin, Kristin Taylor, Linda Bullinga, Brian Cmolik, Joseph Rubelowsky, Gregory Hanson, Matthew Eiseman, Peter Smith, Jeffery Gaca, Mani Daneshnard, Jacob Schroder, John Harvey, Kista Hurley, Scott Edelestein, Jennifer Perna, Melissa Wagner, Stacey Welsh, Donna Marshall, Wade Stinson, Edward Staples, Rebecca Mixon, Courtney Allen, Anne Irwin, Faisal Bakaeen, Shuab Omer, Lorraine Cornwell, Ernesto Jimenez, Anthony Riffel, Antonio Delgado, James Swann, Cynthia Boudreaux, Adrienne Chee, Eugene Grossi, Abelardo DeAnda, Alfred Culliford, Michael DeRosa, George Gogoladze, Tomer Karas, Bethaney Vejdani, Daisy Miriello, Jalima Quintero, Zahir Rashid, Susan Thorson, Mark Garnas, Brittany Smith, Carla Schubert, Sharon Pecsi, Edward McFalls, Herbert Ward, Sara Shumway, Gabriel Loor, Bonnie Marsh, Gayle Breutzman, Katie Thompson, Tacy Meyeraan, Debra Johnson, Daniel Chu, Timothy Miller, Regina Skwortz, Pasala Ravichandran, Merritt Raitt, Catherine Willenborg, Daniel Ruimy, Melody Burman, Karina Dana, Denise Strasser, Sandhya Subramanian, Michael Tanaka, Curt Wozniak, Matheau Julien, Shea Pribyl, Douglas Hintz, Augusto Valera, Dionne Wrights, Kathleen Stanley, Lucinda Casson, Marya Krogstad, Narendra Sastry, Carmen Lopez, Nicy Sebastian, Brenda Hoy, Julie Nisbet, Ileana Fernandez, Carmen Gutierrez, Steven Goldman, Birger Rhenman, Divya Kapoor, Roy Keller, Amani Morgan, Barbara Lambeth

Affiliation

¹ From the Divisions of Cardiac Surgery (M.A.Z., J.A.Q., M.H.) and Cardiology (D.L.B., J.M.G.), Veterans Affairs (VA) Boston Healthcare System and Harvard Medical School, the Department of Surgery, Brigham and Women's Hospital and Harvard Medical School (M.A.Z., J.A.Q., M.H.), Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B.), and Massachusetts General Hospital (J.B.) - all in Boston; the Departments of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland (F.G.B.); the VA Pittsburgh Healthcare System, Pittsburgh (F.G.B.); the Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD (E.M.S., K.B., E.D.); Minneapolis VA Medical Center and University of Minnesota, Minneapolis (R.F.K.); San Francisco VA Medical Center and University of California, San Francisco, San Francisco (E.E.T.); Zablocki VA Medical Center and Medical College of Wisconsin, Milwaukee (G.H.A.); VA Eastern Colorado Healthcare System, Denver (B.H.); the Cooperative Studies Program Pharmacy Coordinating Center, Department of Veterans Affairs, Albuquerque, NM (A.S.); and the Cooperative Studies Program Central Office, Office of Research and Development, Department of Veterans Affairs, Washington, DC (G.D.H.).

PMID: 30417737
DOI: 10.1056/NEJMoa1812390

Randomized Controlled Trial

Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass

Marco A Zenati et al. N Engl J Med. 2019.

. 2019 Jan 10;380(2):132-141.

doi: 10.1056/NEJMoa1812390. Epub 2018 Nov 11.

Authors

Collaborators

REGROUP Trial Investigators:
Cindy Colling, Jennifer M Gabany, Abbas Ardehali, Ramin Ebrahimi, Victor Ferraris, Ronnie Ramadan, Gail MacCallum, Hill Wolfe, Annette Phillips, Perry Point, Michael Beam, Daniel Briones, Joseph Collins, Christine Dalzell, Jeanie Kim, Annette Wiseman, Timothy J O’Leary, Michael Jessen, William Blackwelder, Thomas Burdon, Frank Harrell, Dominick Mariconda, Wen-Chih Hank Wu, Said Yassin, Alvise Bernabei, Richard Rode, Edward Bates, Micah Geuss, John Lucke, Robert Ferguson, Ronald Hill, Paul Ballard, Michael Nicolini, Mariette Coyle, Valerie Allen, Whitney Sprinkle, Jacquelyn Quin, Kristin Taylor, Linda Bullinga, Brian Cmolik, Joseph Rubelowsky, Gregory Hanson, Matthew Eiseman, Peter Smith, Jeffery Gaca, Mani Daneshnard, Jacob Schroder, John Harvey, Kista Hurley, Scott Edelestein, Jennifer Perna, Melissa Wagner, Stacey Welsh, Donna Marshall, Wade Stinson, Edward Staples, Rebecca Mixon, Courtney Allen, Anne Irwin, Faisal Bakaeen, Shuab Omer, Lorraine Cornwell, Ernesto Jimenez, Anthony Riffel, Antonio Delgado, James Swann, Cynthia Boudreaux, Adrienne Chee, Eugene Grossi, Abelardo DeAnda, Alfred Culliford, Michael DeRosa, George Gogoladze, Tomer Karas, Bethaney Vejdani, Daisy Miriello, Jalima Quintero, Zahir Rashid, Susan Thorson, Mark Garnas, Brittany Smith, Carla Schubert, Sharon Pecsi, Edward McFalls, Herbert Ward, Sara Shumway, Gabriel Loor, Bonnie Marsh, Gayle Breutzman, Katie Thompson, Tacy Meyeraan, Debra Johnson, Daniel Chu, Timothy Miller, Regina Skwortz, Pasala Ravichandran, Merritt Raitt, Catherine Willenborg, Daniel Ruimy, Melody Burman, Karina Dana, Denise Strasser, Sandhya Subramanian, Michael Tanaka, Curt Wozniak, Matheau Julien, Shea Pribyl, Douglas Hintz, Augusto Valera, Dionne Wrights, Kathleen Stanley, Lucinda Casson, Marya Krogstad, Narendra Sastry, Carmen Lopez, Nicy Sebastian, Brenda Hoy, Julie Nisbet, Ileana Fernandez, Carmen Gutierrez, Steven Goldman, Birger Rhenman, Divya Kapoor, Roy Keller, Amani Morgan, Barbara Lambeth

Affiliation

¹ From the Divisions of Cardiac Surgery (M.A.Z., J.A.Q., M.H.) and Cardiology (D.L.B., J.M.G.), Veterans Affairs (VA) Boston Healthcare System and Harvard Medical School, the Department of Surgery, Brigham and Women's Hospital and Harvard Medical School (M.A.Z., J.A.Q., M.H.), Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B.), and Massachusetts General Hospital (J.B.) - all in Boston; the Departments of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland (F.G.B.); the VA Pittsburgh Healthcare System, Pittsburgh (F.G.B.); the Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD (E.M.S., K.B., E.D.); Minneapolis VA Medical Center and University of Minnesota, Minneapolis (R.F.K.); San Francisco VA Medical Center and University of California, San Francisco, San Francisco (E.E.T.); Zablocki VA Medical Center and Medical College of Wisconsin, Milwaukee (G.H.A.); VA Eastern Colorado Healthcare System, Denver (B.H.); the Cooperative Studies Program Pharmacy Coordinating Center, Department of Veterans Affairs, Albuquerque, NM (A.S.); and the Cooperative Studies Program Central Office, Office of Research and Development, Department of Veterans Affairs, Washington, DC (G.D.H.).

PMID: 30417737
DOI: 10.1056/NEJMoa1812390

Abstract

Background: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized.

Methods: We randomly assigned patients undergoing CABG at 16 Veterans Affairs cardiac surgery centers to either open or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated.

Results: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15).

Conclusions: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .).

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Comment in

Endoscopic versus open vein-graft harvesting.
Le Bras A. Le Bras A. Nat Rev Cardiol. 2019 Jan;16(1):3. doi: 10.1038/s41569-018-0135-4. Nat Rev Cardiol. 2019. PMID: 30487544 No abstract available.
Open or Endoscopic Vein Harvesting for Coronary-Artery Bypass Grafting.
Verma S, Mazer CD. Verma S, et al. N Engl J Med. 2019 Jan 10;380(2):189-191. doi: 10.1056/NEJMe1814605. N Engl J Med. 2019. PMID: 30625061 No abstract available.
Endoscopic versus Open Vein-Graft Harvesting for CABG.
Saffarzadeh A, Hoag JR, Boffa DJ. Saffarzadeh A, et al. N Engl J Med. 2019 May 30;380(22):e43. doi: 10.1056/NEJMc1904533. N Engl J Med. 2019. PMID: 31141649 No abstract available.
Endoscopic versus Open Vein-Graft Harvesting for CABG.
Li G, Zhang Y, Zheng J. Li G, et al. N Engl J Med. 2019 May 30;380(22):e43. doi: 10.1056/NEJMc1904533. N Engl J Med. 2019. PMID: 31141650 No abstract available.
Endoscopic versus Open Vein-Graft Harvesting for CABG.
Bonchek LI. Bonchek LI. N Engl J Med. 2019 May 30;380(22):e43. doi: 10.1056/NEJMc1904533. N Engl J Med. 2019. PMID: 31141651 No abstract available.
Endoscopic versus Open Vein-Graft Harvesting for CABG.
Dashwood MR. Dashwood MR. N Engl J Med. 2019 May 30;380(22):e43. doi: 10.1056/NEJMc1904533. N Engl J Med. 2019. PMID: 31141652 No abstract available.
Endoscopic vein harvest: benefits beyond (a) reasonable doubt?
Lucchese G, Jarral OA. Lucchese G, et al. J Thorac Dis. 2019 May;11(Suppl 9):S1342-S1345. doi: 10.21037/jtd.2019.04.06. J Thorac Dis. 2019. PMID: 31245128 Free PMC article. No abstract available.

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Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass

Collaborators

Affiliation

Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass

Authors

Collaborators

Affiliation

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