Author + information
- Received July 6, 2016
- Revision received October 1, 2016
- Accepted October 20, 2016
- Published online January 23, 2017.
- Fumiaki Ikeno, MDa,∗ (, )
- Maria Mori Brooks, PhDb,
- Kaori Nakagawa, MDa,
- Min-Kyu Kim, MD, PhDa,
- Hideaki Kaneda, MD, PhDa,
- Yoshiaki Mitsutake, MD, PhDa,
- Helen A. Vlachos, MSb,
- Leonard Schwartz, MDc,
- Robert L. Frye, MDd,
- Sheryl F. Kelsey, PhDb,
- Katsuhisa Waseda, MD, PhDa,
- Mark A. Hlatky, MDa,e,
- BARI-2D Study Group
- aDivision of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California
- bDepartment of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania
- cDivision of Cardiology, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada
- dDivision of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- eDepartment of Health Research and Policy, Stanford University School of Medicine, Stanford, California
- ↵∗Reprint requests and correspondence:
Dr. Fumiaki Ikeno, Department of Cardiology, Stanford University, 300 Pasteur Drive, FALK CVRB CV-007, Stanford, California 94305.
Background The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease.
Objectives This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial.
Methods Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years.
Results A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p < 0.001). Among patients with low SYNTAX scores (≤22), major cardiovascular events did not differ significantly between revascularization and medical therapy, either in the CABG stratum (26.1% vs. 29.9%, p = 0.41) or in the PCI stratum (17.8% vs. 19.2%, p = 0.84). Among patients with mid/high SYNTAX scores, however, major cardiovascular events were lower after revascularization than with medical therapy in the CABG stratum (15.3% vs. 30.3%, p = 0.02), but not in the PCI stratum (35.6% vs. 26.5%, p = 0.12).
Conclusions Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305)
The BARI-2D trial is funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases (U01 HL061744, U01 HL061746, U01 HL061748, U01 HL063804, R21-HL121495). BARI-2D receives significant supplemental funding from GlaxoSmithKline, Lantheus Medical Imaging, Inc. (formerly Bristol-Myers Squibb Medical Imaging, Inc.), Astellas Pharma US, Inc., Merck & Co., Inc., Abbott Laboratories, Inc., and Pfizer, Inc. Generous support is given by Abbott Laboratories Ltd., MediSense Products, Bayer Diagnostics, Becton, Dickinson and Company, J. R. Carlson Labs, Centocor, Inc., Eli Lilly and Company, ILipoScience, Inc., Merck Sante, Novartis Pharmaceuticals Corporation, and Novo Nordisk, Inc. Dr. Brooks has received a research grant from Gilead Sciences, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Ikeno, Brooks, Nakagawa, and Kim contributed equally to this work and are joint first authors. Patrick W. Serruys, MD, PhD, served as Guest Editor for this paper. A full listing of the BARI-2D Study Group can be found in the Online Appendix.
- Received July 6, 2016.
- Revision received October 1, 2016.
- Accepted October 20, 2016.
- American College of Cardiology Foundation