Jose C Nicolau1, Susanna R Stevens2, Hussein R Al-Khalidi2, Fabio B Jatene3, Remo H M Furtado3, Luis A O Dallan3, Luiz A F Lisboa3, Patrice Desvigne-Nickens4, Haissam Haddad5, E Marc Jolicoeur6, Mark C Petrie7, Torsten Doenst8, Robert E Michler9, E Magnus Ohman2, Jyotsna Maddury10, Imtiaz Ali11, Marek A Deja12, Jean L Rouleau6, Eric J Velazquez13, James A Hill14. 1. Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. Electronic address: jose.nicolau@incor.usp.br. 2. Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA. 3. Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. 4. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA. 5. Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. 6. Montreal Heart Institute, Université de Montréal, Quebec, Canada. 7. BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. 8. Department of Cardiothoracic Surgery, University of Jena, Jena, Germany. 9. Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA. 10. Department of Cardiology, Nizams Institute of Medical Sciences, Hyderabad, India. 11. Libin Cardiovascular Institute of Alberta, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada. 12. Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland. 13. Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA. 14. Department of Medicine, University of Florida, Gainesville, FL, USA.
Abstract
BACKGROUND: The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis. OBJECTIVES: The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH. METHODS AND RESULTS:Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05). CONCLUSION: In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov; Identifier: NCT00023595.
RCT Entities:
BACKGROUND: The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis. OBJECTIVES: The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH. METHODS AND RESULTS:Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05). CONCLUSION: In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov; Identifier: NCT00023595.
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