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Long-Term Mortality Follow-Up of Radial Artery Versus Saphenous Vein in Coronary Artery Bypass Grafting: A Multicenter, Randomized Trial

2022; Lippincott Williams & Wilkins; Volume: 146; Issue: 17 Linguagem: Inglês

10.1161/circulationaha.122.062343

1524-4539

Steven Goldman, Madeline McCarren, Gulshan K. Sethi, William L. Holman, Faisal G. Bakaeen, Todd H. Wagner, Yajie Wang, Mei-Chung Shih, Robert Edson,

Coronary Interventions and Diagnostics

HomeCirculationVol. 146, No. 17Long-Term Mortality Follow-Up of Radial Artery Versus Saphenous Vein in Coronary Artery Bypass Grafting: A Multicenter, Randomized Trial Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessLetterPDF/EPUBLong-Term Mortality Follow-Up of Radial Artery Versus Saphenous Vein in Coronary Artery Bypass Grafting: A Multicenter, Randomized Trial Steven Goldman, Madeline McCarren, Gulshan K. Sethi, William Holman, Faisal G. Bakaeen, Todd H. Wagner, Yajie Wang, Mei-Chung Shih, Robert Edson and the CSP #474 Investigators Steven GoldmanSteven Goldman Correspondence to: Steven Goldman, MD, Sarver Heart Center, University of Arizona, 1501 Campbell Ave, Tucson, AZ 85724. Email E-mail Address: [email protected] https://orcid.org/0000-0001-7943-1871 Sarver Heart Center (S.G.), University of Arizona, Tucson , Madeline McCarrenMadeline McCarren Hines VA Pharmacy Benefits Management, IL (M.M.). , Gulshan K. SethiGulshan K. Sethi University of Arizona, Tucson (G.K.S.). , William HolmanWilliam Holman University of Alabama, Birmingham VA Medical Center (W.H.). , Faisal G. BakaeenFaisal G. Bakaeen Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, OH (F.G.B.). , Todd H. WagnerTodd H. Wagner https://orcid.org/0000-0001-7625-3504 VA Health Economics Resource Center, Palo Alto VA, CA (T.H.W.). Department of Surgery, Stanford University, Palo Alto, CA (T.H.W.). , Yajie WangYajie Wang Department of Surgery, Stanford University, Palo Alto, CA (T.H.W.). , Mei-Chung ShihMei-Chung Shih Department of Surgery, Stanford University, Palo Alto, CA (T.H.W.). , Robert EdsonRobert Edson Department of Surgery, Stanford University, Palo Alto, CA (T.H.W.). and the CSP #474 Investigators Originally published24 Oct 2022https://doi.org/10.1161/CIRCULATIONAHA.122.062343Circulation. 2022;146:1323–1325There is debate about whether radial artery (RA) grafts are better conduits than saphenous vein grafts (SVG) for patients undergoing coronary artery bypass grafting. Our Department of Veterans Affairs (VA) multicenter, randomized controlled trial (URL: https://www.clinicaltrials.gov; Unique identifier: NCT00054847) showed no difference in graft patency up to 1 year.1 Here we report a post hoc analysis of long-term all-cause mortality in the 726 of 733 participants who consented to follow-up through VA health care databases. The study was approved by each site's institutional review board; written informed consent was obtained from each patient before screening.1 As in the source trial, baseline, operative, and surgical characteristics were balanced between the groups (data not shown). The only difference was longer time in the intensive care unit for patients with RA grafts. Survival was measured from randomization to death or February 15, 2021 (when mortality was extracted from the VA database), whichever was earlier. The median survival was 14.6 years for SVG and 14.2 years for RA grafts (log rank test P=0.89) (Figure). After adjustment for prespecified covariates including age, Canadian Cardiovascular Society Angina Class, smoking status, total cholesterol, high-density lipoprotein, triglycerides, diabetes, hypertension, and heart failure, there was no difference in mortality between the 2 graft types (adjusted hazard ratio, 1.12 [95% CI, 0.91–1.38). We conducted post hoc subgroup analyses using Cox proportional hazards models baseline variables that were included in the model associated with survival <0.05. The subgroups included age (<65 versus ≥65 years), smoking status (never, past, current), diabetes, hypertension, and triglycerides (<150 versus ≥150 mg/dL). Survival did not differ significantly between graft types for any of the subgroups examined. None of the graft type by subgroup interactions were statistically significant.Download figureDownload PowerPointFigure. Kaplan-Meier survival curve in patients entered into the study. Patients who received saphenous vein grafts (SVG) are shown in red, and patients who received radial artery grafts are shown in blue (95% CIs are in pink for the SVG group and in cyan for the radial artery group). There is no difference in survival up to 17.95 years after coronary artery bypass grafting. The number of patients at risk at each 5-year interval is shown on the x axis. HR indicates hazard ratio.Some observational data have associated radial artery use with reduced all-cause mortality.2 Those outcomes are likely influenced by surgeon expertise and imperfect risk adjustment. The latter cannot account for residual confounding because of unmeasured variables including patient frailty, target vessel and conduit size and quality, and target vessel stenosis. Therefore, there is a risk of bias introduced by healthier patients with better targets receiving radial grafts. No randomized controlled trial has demonstrated a survival advantage of radial artery versus SVG. Most randomized controlled trials have focused on short- to mid-term graft patency or clinical outcomes. However, longer follow-up is critical to determining whether radial artery grafting is more effective than SVG, because failure of SVG typically occurs 5 to 10 years after coronary artery bypass grafting. Only the RAPCO Trial (Radial Artery Patency and Clinical Outcomes) was designed to look at long-term clinical outcomes and reported for RA versus SVG 10-year patency of 85% versus 71%, and 10-year patient survival of 72.6% versus 65.2%. The RAPCO trial was limited by small patient numbers (n=225) and excluded patients younger than 70 years. Our trial had no adult age restriction and almost 18 years of follow-up.An individual participant data meta-analysis with a median follow-up of 10 years showed a reduction in the composite of death, myocardial infarction, or repeat revascularization with RA versus SVG.3 This study incorporated 6 small studies (1036 patients), mainly at non–United States centers with established expertise in radial artery grafting. Among those trials, strict patient and target selection criteria were universal and surgeons with extensive experience in radial artery grafting. Thus, their outcomes may not be generalizable to the average surgical practice. In our study, there were no requirements for radial artery grafting experience at the 11 centers. Critics may explain the nonsuperiority of the radial artery graft in our study on the basis of lower quality of radial grafting. However, our perioperative mortality (0.5% in SVG and 0.8% in RA), graft patency rates at 1 week (97%) and 1 year (89%) across the 2 groups, and internal thoracic artery graft patency at 1 year (96%)4 compare favorably with other studies. Our findings are consistent with no incremental benefit towards survival beyond that achieved by a patent left internal thoracic artery (to the left anterior descending artery. Data sharing is available from the VA Cooperative Studies Program (see Sources of Funding).The choice of the second-best conduit to supplement the left internal thoracic artery to left anterior descending artery is unsettled. The 2016 Society of Thoracic Surgeons arterial conduits guidelines encouraged (class IIa recommendation) the use of radial arteries in selected patients as a supplement to left internal thoracic artery to the left anterior descending artery. The 2021 ACC/AHA/SCAI Coronary Revascularization guidelines assigned radial artery use a class I (standard of care) recommendation,4 but this was challenged and not endorsed by the AATS and Society of Thoracic Surgeons or the European Association of Cardio-Thoracic Surgery because of lack of robust supporting evidence. It is important that the lack of support for using the radial artery as a preferred conduit during coronary artery bypass grafting has resulted in it being used <10% of the time in the United States.5 Our findings do not support the use of the radial artery as a class I recommendation.Article InformationREGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00054847.AcknowledgmentsParticipating VA Medical Centers: (site investigators, subinvestigators, and study coordinators): New Mexico: Michelle Ratliff, MD; Stuart Pett, MD; Robin Elliot, RN; Karon Wagoner, RN (past). Michigan: Claire Duvernoy, MD; Marvin Kirsh, MD (past); Himanshu Patel, MD; Patricia Teague, RN; Connie Newman, RN (past). Alabama: William Holman, MD; Jose Tallaj, MD; Gilbert Zoghbi, MD; Raed Aquel, MD (past); Barbara Sanders, RN. West Roxbury: Miguel Haime, MD; Michael Crittenden, MD (past); Scott Kinlay, MD; Lorrie Kelley, RN. Hines: Donald Thomas, MD; William Gunnar, MD (past); Natalie Mecum; Nancy Fink (past). Texas: Faisal Bakaeen, MD; Joseph Huh, MD (past); Ernesto Soltero, MD (past); Gabriel Habib, MD; Pamela Smithwick, RN. Alabama: Mohammed Moursi, MD; Gareth Tobler, MD (past); Barry Uretsky, MD; Luis Garza, MD (past); Sandra Brock, RN; Paul Boynton, MA (past); Kathryn Adams (past). Minnesota: Edward McFalls, MD; Rosemary Kelly, MD; Herb Ward, MD (past); Deborah Johnson, RN. New Orleans: Anand Irimpen, MD; Lynn Harrison, MD; Monica Mason, RN. Virginia: Vigneshwar Kasirajan, MD; Anthony Minisi, MD; Heather Hodges, RN. Arizona: Hoang Thai, MD; Douglass Morrison, MD (past); Birger Rhenman, MD; Sherry Daugherty, BS; Monica Johnson; Janet Ohm, PhD (past); Nancy Tost, RN (past).Palo Alto VA Cooperative Studies Program Coordinating Center: Director: Ying Chen, PhD; Mei-Chiung Shih, PhD (acting, past); Ying Lu, PhD (past); Mark Holodniy, MD (acting, past); Javaid Sheikh, MD, MBA (past); Philip Lavori, PhD (past); Study Biostatistician: Kelvin Lee, PhD; Mei-Chiung Shih, PhD; Assisting Biostatistician: Bob Edson, MA; Project Manager: Lori Planting, BA; Statistical Programmer: Yajie Wang, MS; Clinical Data Manager: Aileen Baylosis; Julie Pitts (past); Johanna Bronner (past); Jessica Shah (past); Briana Davis (past); Project Coordinator: Anita Kelley; Lisa Nuckles (past); Elaine Nastor (past); Data Management Programmer: Joanna Thorgrimsson (past); Andres Busette; Meredith Miller, MA; Clinical Data Associate: Michelle Mullens; Pei-Pei Woo.Health Economics Resource Center: Director and Health Economist: Todd Wagner, PhD; Programmer: Lakshmi Ananth; Leonor Ayyangar.Cooperative Studies Program VA Central Office, Washington, DC: Director: Timothy J. O'Leary, MD, PhD (past); Grant D. Huang, MPH, PhD.The contents of this article do not represent the views of the Department of Veterans Affairs of the US Government.Sources of FundingThis trial was sponsored by the Department of Veterans Affairs Cooperative Studies Program. Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the VA Cooperative Studies Program Coordinating Center, Palo Alto Coordinating Center, 701-B N Shoreline Blvd, Mountain View, CA 94043-3208.Disclosures None.FootnotesCirculation is available at www.ahajournals.org/journal/circThe podcast and transcript are available as Supplemental Material at https://www.ahajournals.org/doi/suppl/10.1161/CIRCULATIONAHA.122.062343.For Sources of Funding and Disclosures, see page 1325.Correspondence to: Steven Goldman, MD, Sarver Heart Center, University of Arizona, 1501 Campbell Ave, Tucson, AZ 85724. Email [email protected]arizona.eduReferences1. Goldman S, Sethi G, Holman W, Thai H, McFalls E, Ward HB, Kelly RF, Rhenman B, Tobler GH, Bakaeen FG, et al. Radial artery grafts vs saphenous vein grafts in coronary artery bypass surgery: a randomized trial.JAMA. 2011; 305:167–174. doi: 10.1001/jama.2010.1976.CrossrefMedlineGoogle Scholar2. Gaudino M, Rahouma M, Abouarab A, Leonard J, Kamel M, Di Franco A, Demetres M, Tam DY, Tranbaugh R, Girardi LN, et al. Radial artery versus saphenous vein as the second conduit for coronary artery bypass surgery: a meta-analysis.J Thorac Cardiovasc Surg. 2019; 157:1819–1825.e10. doi: 10.1016/j.jtcvs.2018.08.123CrossrefMedlineGoogle Scholar3. Gaudino M, Benedetto U, Fremes S, Ballman K, Biondi-Zoccai G, Sedrakyan A, Nasso G, Raman J, Buxton B, Hayward PA, et al; RADIAL Investigators. Association of radial artery graft vs saphenous vein graft with long-term cardiovascular outcomes among patients undergoing coronary artery bypass grafting: a systematic review and meta-analysis.JAMA. 2020; 324:179–187. doi: 10.1001/jama.2020.8228CrossrefMedlineGoogle Scholar4. Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, et al. 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2022; 145:e18–e114. doi: 10.1161/CIR.0000000000001038LinkGoogle Scholar5. Schwann TA, Habib RH, Wallace A, Shahian DM, O'Brien S, Jacobs JP, Puskas JD, Kurlansky PA, Engoren MC, Tranbaugh RF, et al. Operative outcomes of multiple-arterial versus single-arterial coronary bypass grafting.Ann Thorac Surg. 2018; 105:1109–1119. doi: 10.1016/j.athoracsur.2017.10.058CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Nezic D (2023) Long-term survival in coronary artery bypass grafting surgery depending on the second conduit used, Trends in Cardiovascular Medicine, 10.1016/j.tcm.2022.12.003, 33:3, (192), Online publication date: 1-Apr-2023. Audisio K, Dimagli A and Gaudino M (2023) Radial artery or saphenous vein?, Trends in Cardiovascular Medicine, 10.1016/j.tcm.2022.12.002, 33:3, (193-194), Online publication date: 1-Apr-2023. October 25, 2022Vol 146, Issue 17 Advertisement Article InformationMetrics © 2022 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.122.062343PMID: 36279414 Originally publishedOctober 24, 2022 Keywordsradial arterycoronary artery disease/surgerysaphenous veincoronary artery bypass grafting/methodsmyocardial infarctionPDF download Advertisement SubjectsCardiovascular Surgery