Author + information
- Received September 14, 2015
- Accepted October 4, 2015
- Published online January 5, 2016.
- Amit P. Amin, MD, MSc∗,†,
- Tracy Y. Wang, MD, MHS, MS‡,
- Lisa McCoy, MS‡,
- Richard G. Bach, MD∗,†,
- Mark B. Effron, MD‡,
- Eric D. Peterson, MD, MPH§ and
- David J. Cohen, MD, MSc‖,¶∗ ()
- ∗Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri
- †Barnes-Jewish Hospital, St. Louis, Missouri
- ‡Lilly Research Laboratories, Indianapolis, Indiana
- §Division of Cardiology, Duke University Medical Center, Durham, North Carolina
- ‖Saint Luke’s Mid America Heart Institute, Kansas City, Missouri
- ¶University of Missouri–Kansas City, Kansas City, Missouri
- ↵∗Reprint requests and correspondence:
Dr. David J. Cohen, Saint Luke’s Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111.
Background Prolonged dual antiplatelet therapy (DAPT) is recommended after an acute myocardial infarction (AMI) to reduce ischemic events but is associated with increased rates of major and minor bleeding.
Objectives This study sought to determine the incidence of post-percutaneous coronary intervention (PCI) bleeding that occurs on contemporary DAPT and its impact on quality of life (QOL).
Methods We studied 9,290 AMI patients treated with PCI and discharged alive between April 2010 and September 2012. Post-discharge bleeding was categorized according to the Bleeding Academic Research Consortium (BARC) definition. The primary outcome was the 6-month Euro QOL–5 Dimension (EQ-5D) index score (a measure of health utility); a secondary outcome was the EQ-5D visual analog scale (VAS) at 6 months.
Results Of the 9,290 patients with AMI, bleeding events occurred as follows: any BARC bleeding: 24.2%; BARC 1: 9.1%; BARC 2: 13.8%; BARC 3: 1.1%; BARC 4: 0.03%; and BARC 5: 0%. Those who experienced any BARC bleeding had lower scores across all 5 EQ-5D domains (mobility, self-care, usual activities, pain, and anxiety), as well as lower EQ-5D VAS and EQ-5D index scores. After clinical risk adjustment, any BARC bleeding was independently associated with 6-month EQ-5D index score (p < 0.0001) and lower QOL (p < 0.001). Both the EQ-5D index and the VAS score declined in a stepwise fashion with increasing BARC severity.
Conclusions Among patients undergoing PCI for AMI, bleeding during follow-up was associated with worse 6-month utility and QOL. Although even minor bleeding was associated with impaired health status and QOL, the degree of impairment increased in a stepwise fashion with bleeding severity.
The TRANSLATE-ACS study is sponsored by Daiichi-Sankyo and Eli Lilly and Company. Dr. Amin is funded via a comparative effectiveness research KM1 career development award from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences of the National Institutes of Health, grant numbers UL1TR000448, KL2TR000450, and TL1TR000449, National Cancer Institute of the National Institutes of Health, grant number 1KM1CA156708-01, an R18 grant from the Agency for Healthcare Research and Quality, grant number R18HS0224181, and 2 additional grants by the Barnes Jewish Hospital Foundation; has received research funding from Volcano; and is a consultant for Terumo, The Medicines Company, and AstraZeneca. Dr. Wang has received research grant support to the Duke Clinical Research Institute from Eli Lilly and Company, Daiichi-Sankyo, Gilead Sciences, GlaxoSmithKline, AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Regeneron; and has received honoraria from AstraZeneca and the American College of Cardiology Foundation. Dr. Bach has received research funding from AstraZeneca, Eli Lilly and Company, GlaxoSmithKline, and Volcano; and is a consultant on clinical event committees for Eli Lilly and Company and Novo Nordisk. Dr. Effron is an employee and shareholder of Eli Lilly and Company. Dr. Peterson has received research grants to the Duke Clinical Research Institute from Janssen Pharmaceuticals, Boehringer Ingelheim, Merck & Co., Sanofi, Bayer, and AstraZeneca. Dr. Cohen has received research grant support from Boston Scientific, Medtronic, Abbott Vascular, Eli Lilly and Company, Daiichi-Sankyo, AstraZeneca, Merck & Co., and Edwards Lifesciences; consulting fees from Medtronic, Abbott Vascular, Merck & Co., and AstraZeneca; and speaking honoraria from Eli Lilly and Company and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Paul Gurbel, MD, served as Guest Editor for this paper.
- Received September 14, 2015.
- Accepted October 4, 2015.
- American College of Cardiology Foundation