Michael R MacDonald1, Lilin She2, Torsten Doenst3, Philip F Binkley4, Jean L Rouleau5, Ru-San Tan6, Kerry L Lee7, Alan B Miller8, George Sopko9, Dominika Szalewska10, Myron A Waclawiw9, Rafal Dabrowski11, Serenella Castelvecchio12, Christopher Adlbrecht13, Robert E Michler14, Jae K Oh15, Eric J Velazquez16, Mark C Petrie17. 1. Department of Cardiology, Changi General Hospital, Singapore. 2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA. 3. Department of Cardiothoracic Surgery, Jena University Hospital, Friedrich Schiller University, Jena, Germany. 4. The Ohio State University Wexner Medical Center, Columbus, OH, USA. 5. Montréal Heart Institute, Université de Montréal, Canada. 6. National Heart Centre, Singapore. 7. Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA. 8. Department of Cardiology, University of Florida, Jacksonville, FL, USA. 9. National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA. 10. Department of Rehabilitation, Medical University of Gdansk, Gdansk, Poland. 11. Institute of Cardiology, Warsaw, Poland. 12. IRCCS Policlinico San Donato, Milan, Italy. 13. Department of Medicine II, Division of Cardiology, Medical University of Vienna, Austria. 14. Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York City, NY, USA. 15. Department of Medicine, Mayo Clinic, Rochester, MN, USA. 16. Department of Medicine-Cardiology, Duke University School of Medicine, Durham, NC, USA. 17. Scottish National Advanced Heart Failure Service, Golden Jubilee National Hospital, and University of Glasgow, Glasgow, UK.
Abstract
AIMS: Hypothesis 1 of the Surgical Treatment for Ischemic Heart Failure (STICH) trial enrolled 1212 patients with an LVEF of ≤35% and CAD amenable to coronary artery bypass grafting (CABG). Patients were randomized to CABG and optimal medical therapy (MED) or MED alone. The objective was to assess whether or not patients with diabetes mellitus (DM) enrolled in the STICH trial would have greater benefit from CABG than patients without DM. METHODS AND RESULTS: The characteristics and clinical outcomes of patients with and without DM randomized toCABG and MED or MED alone were compared. DM was present in 40%. At baseline, patients with DM had more triple vessel CAD, higher LVEF, and smaller left ventricular volumes. In patients with DM, the primary outcome of all-cause mortality occurred in 39% of patients in the MED group and 39% in the CABG group [hazard ratio (HR) with CABG 0.96, 95% confidence interval (CI) 0.73-1.26]. In patients without DM, the primary outcome occurred in 41% of patients in the MED group and 32% in the CABG group (HR with CABG 0.80, 95% CI 0.63-1.02). While numerically it would appear that the treatment effect of CABG is blunted in patients with DM, there was no significant interaction between DM and treatment group on formal statistical testing. CONCLUSIONS:Patients with DM enrolled in the STICH trial had more triple vessel disease, smaller hearts, and higher LVEF than those without DM. CABG did not exert greater benefit in patients with DM.
RCT Entities:
AIMS: Hypothesis 1 of the Surgical Treatment for Ischemic Heart Failure (STICH) trial enrolled 1212 patients with an LVEF of ≤35% and CAD amenable to coronary artery bypass grafting (CABG). Patients were randomized to CABG and optimal medical therapy (MED) or MED alone. The objective was to assess whether or not patients with diabetes mellitus (DM) enrolled in the STICH trial would have greater benefit from CABG than patients without DM. METHODS AND RESULTS: The characteristics and clinical outcomes of patients with and without DM randomized to CABG and MED or MED alone were compared. DM was present in 40%. At baseline, patients with DM had more triple vessel CAD, higher LVEF, and smaller left ventricular volumes. In patients with DM, the primary outcome of all-cause mortality occurred in 39% of patients in the MED group and 39% in the CABG group [hazard ratio (HR) with CABG 0.96, 95% confidence interval (CI) 0.73-1.26]. In patients without DM, the primary outcome occurred in 41% of patients in the MED group and 32% in the CABG group (HR with CABG 0.80, 95% CI 0.63-1.02). While numerically it would appear that the treatment effect of CABG is blunted in patients with DM, there was no significant interaction between DM and treatment group on formal statistical testing. CONCLUSIONS:Patients with DM enrolled in the STICH trial had more triple vessel disease, smaller hearts, and higher LVEF than those without DM. CABG did not exert greater benefit in patients with DM.
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