Prospective utility study of patients with multiple cardiovascular events

Abstract

Objectives: The effects of acute coronary syndrome (ACS) events on health-related quality-of-life (HRQoL) and the time dependency of these effects are unknown. This study aimed to characterize health utilities in ACS patients to aid development of future economic models estimating the cost per quality-adjusted life-year impact of ACS events and potential treatments.

Methods: Multi-center, non-interventional, longitudinal evaluation of health utility in patients experiencing ACS or stroke events. EuroQol-5 dimension 3 level (EQ-5D-3L) surveys were sent to patients (≥18 years) from three UK centers, 1 month after hospital discharge for myocardial infarction (MI), unstable angina (UA), or stroke. Patient demographics, lifestyle, and baseline utility score were collected in the first survey. Follow-up surveys were sent at 6, 12, 18, and 24 months to prospectively capture utility and subsequent health events. Two methods of patient identification were adopted—prospective, where the patient’s qualifying events occurred after the study index date, and retrospective, where the patient’s qualifying event occurred prior to the study index date. General healthy population utility values were assumed for pre-event HRQoL.

Results: Between January 2011 and March 2014, 2,103 prospectively (n = 1,350)/retrospectively (n = 753) identified patients (mean age = 68.3 years; 67.9% male) responded: MI = 55.9% (n = 1,176), UA = 42.7% (n = 898), stroke = 1.4% (n = 29); 24% had type 2 diabetes. Post-event utility values were lower than general healthy population values, although significant differences in utility between subsequent 6 (n = 1,031, change = –0.002), 12 (n = 1,096, change = –0.008), 18 (n = 1,246, change = –0.007), and 24 (n = 1,277, change = –0.004) month timepoints were not detected. Through multivariate regression analyses, wheelchair use, current smoking, and secondary mental and joint health events were associated with the greatest statistically significant utility decrements.

Conclusions: This study indicates that health utility decreases following a cardiovascular event and, although some improvement occurs over the subsequent 24 months, general healthy population utility is not necessarily attained.

Keywords:

• Acute coronary syndrome
• cardiovascular disease
• health utilities
• health-related quality-of-life

Transparency

Declaration of funding

This study was sponsored by Roche Products Ltd. The non-interventional nature of the study means that it was not registered on any commonly used clinical trial databases. Third-party medical writing assistance was funded by Roche Products Ltd.

Declaration of financial/other relationships

JR and SS are employed and paid by F. Hoffmann-La Roche, Basel, Switzerland. IT is employed and paid by Roche Products Ltd, Welwyn Garden City, UK. All other authors declare no financial/other relationships. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Roche thanks the Swansea Centre for Health Economics (SCHE), formerly the Cardiff Research Consortium (CRC), for contributing to the study, data analysis, and interpretation. The protocol and data analysis plan were developed jointly by the sponsor and CRC personnel with final approval by the sponsor. Support for third-party medical writing assistance was provided by SCHE and Miller Medical Communications Ltd (both funded by Roche Products Ltd).