André Lamy1, P J Devereaux1, Dorairaj Prabhakaran1, David P Taggart1, Shengshou Hu1, Zbynek Straka1, Leopoldo S Piegas1, Alvaro Avezum1, Ahmet R Akar1, Fernando Lanas Zanetti1, Anil R Jain1, Nicolas Noiseux1, Chandrasekar Padmanabhan1, Juan-Carlos Bahamondes1, Richard J Novick1, Liang Tao1, Pablo A Olavegogeascoechea1, Balram Airan1, Toomas-Andres Sulling1, Richard P Whitlock1, Yongning Ou1, Peggy Gao1, Shirley Pettit1, Salim Yusuf1. 1. From the Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON (A.L., P.J.D., R.P.W., Y.O., P.G., S.P., S.Y.), Centre Hospitalier de l'Université de Montréal, Montreal (N.N.), and the University of Calgary, Calgary, AB (R.J.N.) - all in Canada; the Center for Chronic Disease Control, Gurgaon (D.P.), SAL Hospital, Ahmedabad (A.R.J.), G. Kuppuswamy Naidu Memorial Hospital, Coimbatore (C.P.), and All India Institute of Medical Sciences, New Delhi (B.A.) - all in India; the University of Oxford, Oxford, United Kingdom (D.P.T.); Fu Wai Cardiovascular Hospital, Xicheng District, Beijing (S.H.), and Wuhan Asia Heart Hospital, Wuhan (L.T.) - both in China; Third Faculty of Medicine Charles University, University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.S.); Instituto Dante Pazzanese de Cardiologia, São Paulo (L.S.P., A.A.); Ankara University School of Medicine, Ankara, Turkey (A.R.A.); Hospital Regional de Temuco and Universidad de la Frontera, Temuco, Chile (F.L.Z., J.-C.B.); Fundación Médica de Río Negro y Neuquén, Rio Negro, Argentina (P.A.O.); and North Estonia Medical Center, Tallinn, Estonia (T.-A.S.).
Abstract
BACKGROUND: We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial). METHODS: A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG. For this report, we analyzed a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization (either CABG or percutaneous coronary intervention). The mean follow-up period was 4.8 years. RESULTS: There were no significant differences between the off-pump group and the on-pump group in the rate of the composite outcome (23.1% and 23.6%, respectively; hazard ratio with off-pump CABG, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72) or in the rates of the components of the outcome, including repeat coronary revascularization, which was performed in 2.8% of the patients in the off-pump group and in 2.3% of the patients in the on-pump group (hazard ratio, 1.21; 95% CI, 0.85 to 1.73; P=0.29). The secondary outcome for the overall period of the trial - the mean cost in U.S. dollars per patient - also did not differ significantly between the off-pump group and the on-pump group ($15,107 and $14,992, respectively; between-group difference, $115; 95% CI, -$697 to $927). There were no significant between-group differences in quality-of-life measures. CONCLUSIONS: In our trial, the rate of the composite outcome of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 years of follow-up was similar among patients who underwent off-pump CABG and those who underwent on-pump CABG. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294 .).
RCT Entities:
BACKGROUND: We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial). METHODS: A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG. For this report, we analyzed a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization (either CABG or percutaneous coronary intervention). The mean follow-up period was 4.8 years. RESULTS: There were no significant differences between the off-pump group and the on-pump group in the rate of the composite outcome (23.1% and 23.6%, respectively; hazard ratio with off-pump CABG, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72) or in the rates of the components of the outcome, including repeat coronary revascularization, which was performed in 2.8% of the patients in the off-pump group and in 2.3% of the patients in the on-pump group (hazard ratio, 1.21; 95% CI, 0.85 to 1.73; P=0.29). The secondary outcome for the overall period of the trial - the mean cost in U.S. dollars per patient - also did not differ significantly between the off-pump group and the on-pump group ($15,107 and $14,992, respectively; between-group difference, $115; 95% CI, -$697 to $927). There were no significant between-group differences in quality-of-life measures. CONCLUSIONS: In our trial, the rate of the composite outcome of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 years of follow-up was similar among patients who underwent off-pump CABG and those who underwent on-pump CABG. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294 .).
Authors: Fabio Ramponi; Michael Seco; James B Edelman; Andrew G Sherrah; Paul G Bannon; R John L Brereton; Michael K Wilson; Michael P Vallely Journal: Ann Cardiothorac Surg Date: 2018-07
Authors: Maria Tafelmeier; Teresa Weizenegger; Sarah Ripfel; Miriam Fauser; Bernhard Floerchinger; Daniele Camboni; York Zausig; Sigrid Wittmann; Marzena A Drzymalski; Florian Zeman; Christof Schmid; Lars S Maier; Stefan Wagner; Michael Arzt Journal: Clin Res Cardiol Date: 2018-06-12 Impact factor: 5.460