Assessing the impact of cardiovascular events on health-related quality of life outcomes in DAPA-HF

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Abstract Background Heart failure (HF) patients are at increased risk of cardiovascular (CV) events, including hospitalisation for HF (hHF), myocardial infarction (MI) and stroke, imposing a significant burden on health related quality of life (HRQoL). DAPA-HF was a multinational clinical trial (NCT03036124) investigating the efficacy and safety of dapagliflozin for the treatment of HF with reduced ejection fraction. Patient reported outcomes were collected. The objective of this study was to estimate the impact of CV events on patient HRQoL over time, as assessed through EQ-5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score (TSS) and clinical symptom score (CSS). Methods Mixed effects regression models were developed based on pooled individual patient data from DAPA-HF to estimate the impact of hHF, MI and stroke on patient utility (EQ-5D-5L questionnaire responses weighted according to the societal value placed on given health states), and KCCQ TSS score. Utility was estimated using UK-specific tariffs after mapping EQ-5D-5L to EQ-5D-3L values in line with NICE guidance. A subject-specific intercept was incorporated, and estimates were adjusted for the incidence of events occurring within one month prior, two to four months prior, and 4 to 12 months prior to questionnaire completion. Results Mean patient baseline utility was 0.716 (95% CI: 0.711, 0.722), with KCCQ TSS 73.6 (73.0, 74.2). The incidence of CV events was consistently associated with reduced patient HRQoL, assessed through either EQ-5D or KCCQ TSS. In the first month following the event, hHF was associated with a 0.083 (0.06, 0.107) reduction in patient utility, and 16.9 (14.5, 19.4) reduction in KCCQ TSS (Fig. 1). Comparing measures, the disease specific measure KCCQ appeared more sensitive than EQ-5D to changes in HRQoL following hHF events and less sensitive to changes following MI and stroke events. Comparing events using the generic EQ-5D measure, at two months post-event, patients with MI and stroke returned to baseline utility; patients with hHF remained below baseline utility at each assessment point for 12 months (Fig. 2); where patients had a mean reduction of 0.02 (0.005, 0.035) utility and 0.5 (−1.1, 2.1) KCCQ-TSS compared to those without an hHF event. Conclusion The incidence of cardiovascular events imposes a considerable burden on HRQoL in patients with HFrEF. HF specific events may be better characterised with a disease specific tool, whereas for wider CV events a generic tool may be preferable. The impact of hHF on HRQoL was noteworthy in its persistence across the measures used up to one year. Interventions that reduce the risk of these events have the potential to significantly improve patient quality of life. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): AstraZeneca