Author + information
- Received November 2, 2012
- Revision received December 17, 2012
- Accepted January 8, 2013
- Published online April 30, 2013.
- Jacqueline E. Tamis-Holland, MD⁎,⁎ (, )
- Jiang Lu, MS†,
- Mary Korytkowski, MD†,
- Michelle Magee, MD‡,
- William J. Rogers, MD§,
- Neuza Lopes, MD∥,
- Lisa Mighton, RN¶,
- Alice K. Jacobs, MD#,
- BARI 2D Study Group
- ↵⁎Reprint requests and correspondence:
Dr. Jacqueline E. Tamis-Holland, St. Luke's-Roosevelt Hospital Center, Division of Cardiology, 1111 Amsterdam Avenue, S&R 3 New York, New York 10025
Objectives This study evaluated differences in outcome among women and men enrolled in the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial.
Background Women and men with coronary artery disease have different clinical presentations and outcomes that might be due to differences in management.
Methods We compared baseline variables, study interventions, and outcomes between women and men enrolled in the BARI 2D trial and randomized to aggressive medical therapy alone or aggressive medical therapy with prompt revascularization.
Results At enrollment, women were more likely than men to have angina (67% vs. 58%, p < 0.01) despite less disease on angiography (Myocardial Jeopardy Index 41 ± 24 vs. 46 ± 24, p < 0.01; number of significant lesions 2.3 ± 1.7 vs. 2.8 ± 1.8, p < 0.01). Over 5 years, no sex differences were observed in BARI 2D study outcomes after adjustment for difference in baseline variables (death/myocardial infarction/cerebrovascular accident: hazard ratio: 1.11, 99% confidence interval [CI]: 0.85 to 1.44). However, women reported more angina than men (adjusted odds ratio: 1.51, 99% CI: 1.21 to 1.89, p < 0.0001) and had lower scores for the Duke Activity Status Index (adjusted beta coefficient: −1.58, 99% CI: −2.84 to −0.32, p < 0.01).
Conclusions There were no sex differences in death, myocardial infarction, or cerebrovascular accident among patients enrolled in the BARI 2D trial. However, compared with men, women had more symptoms and less anatomic disease at baseline, with persistence of higher angina rates and lower DASI scores after 5 years of medical therapy with or without prompt revascularization. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305)
The BARI 2D trial was 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). The BARI 2D trial received significant supplemental funding from GlaxoSmithKline and additional funding from Lantheus Medical Imaging, Inc. (formerly Bristol-Myers Squibb Medical Imaging, Inc.), AstellasPharma US, Inc., Merck & Co., Inc., Abbott Laboratories, Inc., and Pfizer, Inc. Medications and supplies were donated by Abbott Laboratories, Ltd., MediSense Products, Bayer Diagnostics, Becton, Dickinson and Company, J. R. Carlson Labs, Centocor, Inc., Eli Lilly and Company, LipoScience, Inc., Merck Sante, Novartis Pharmaceuticals Corporation, and Novo Nordisk, Inc. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, or the NIH. Dr. Korytkowski has received research support from Sanofi Aventis; and served as consultant to Regeneron. Dr. Magee has relationships with the American Diabetes Association, Esai, Boehringer-Ingelheim Cascade 8, Lilly REWIND, Washington DC Department of Health, AstraZeneca, American College of Cardiology DM & CVD CME program, and Quintiles/GE Centricity/Sanofi DIABETES FORWARD. Ms. Mighton has received compensation for training healthcare professionals and patients for Abbot Diabetes Care. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 2, 2012.
- Revision received December 17, 2012.
- Accepted January 8, 2013.
- American College of Cardiology Foundation