Author + information
- Received February 19, 2013
- Revision received October 8, 2013
- Accepted December 3, 2013
- Published online April 1, 2014.
- Eldrin F. Lewis, MD, MPH∗∗ (, )
- Yanhong Li, MS†,
- Marc A. Pfeffer, MD, PhD∗,
- Scott D. Solomon, MD∗,
- Kevin P. Weinfurt, PhD†,
- Eric J. Velazquez, MD†,
- Robert M. Califf, MD†,
- Jean-Lucien Rouleau, MD‡,
- Lars Kober, MD§,
- Harvey D. White, DSc‖,
- Kevin A. Schulman, MD† and
- Shelby D. Reed, PhD†
- ∗Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
- †Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
- ‡Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada
- §Rigshospitalet, Copenhagen, Denmark
- ‖Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
- ↵∗Reprint requests and correspondence:
Dr. Eldrin F. Lewis, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts 02115.
Objectives The objective of this study was to determine the impact of nonfatal cardiovascular (CV) events on changes in health-related quality of life (HRQL).
Background There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors of myocardial infarction (MI).
Methods The VALIANT (Valsartan In Acute Myocardial Infarction) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher (scale measuring heart failure severity post-MI ranging from class I to IV) and/or reduced ejection fraction. The HRQL substudy included 2,556 (17.4%) patients who completed the EQ-5D with 5 questions, with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale (VAS) ranging from 0 (worst) to 100 (best) imaginable health state. EQ-5D was administered at baseline and 6, 12, 20, and 24 months. The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events. Patients who died before the next EQ-5D assessment were excluded.
Results Over a 2-year period, 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment. Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event (VAS 61.0 ± 19 vs 68.2 ± 18 [p < 0.001] and US-based utility score 0.76 ± 0.22 vs 0.83 ± 0.17 [p < 0.001]). These patients with CV events experienced a trajectory-adjusted 6.6 point decrease (p < 0.001) in VAS scores and a 0.07 decrease (p < 0.001) in utility score after the nonfatal CV event.
Conclusions MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory, suggesting that generic instruments can be responsive to nonfatal events. Reduction in nonfatal CV events may affect longitudinal changes in HRQL.
VALIANT was funded by a research grant from Novartis, Inc. There was no input from Novartis on the content or analysis related to the manuscript and no funding was received for the manuscript. Drs. Lewis and Solomon have received grant research support from Novartis. Dr. Pfeffer has done consulting with Aastrom, Boston Scientific, Bristol-Myers Squibb, Cerenis, HamiltonHealth Sciences, Novartis, Roche, Sanofi Aventis, Servier, and the University of Oxford; research grants to the Brigham and Women's Hospital have been given by Amgen, Novartis, and Sanofi Aventis; the Brigham and Women's Hospital has patents for the use of inhibitors of the renin-angiotensin system in selected survivors of myocardial infarction with Novartis and Boehringer; and is a co-inventor, and his share of the licensing agreements is irrevocably transferred to charity. Dr. Velazquez has acted as a consultant for Novartis. Dr. Califf has served as a board member of Portola Pharma; and has minor equity in N30 Therapeutics. Dr. Kober has served as a symposium speaker for Servier. Dr. White has done consulting with AstraZeneca, Merck Sharpe & Dohme, Roche, and Regado Biosciences; and he has received research support from Sanofi Aventis, Eli Lilly and Company, The Medicines Company, National Institutes of Health, Roche, Merck Sharpe & Dohme, AstraZeneca, GlaxoSmithKline, and Daiichi Sankyo PharmaDevelopment. Dr. Schulman has received research funding and consulting income from Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 19, 2013.
- Revision received October 8, 2013.
- Accepted December 3, 2013.
- American College of Cardiology Foundation