Impact of COVID‐19 in patients with heart failure with mildly reduced or preserved ejection fraction enrolled in the DELIVER trial (original) (raw)

Bhatt, A. S. et al. (2023) Impact of COVID‐19 in patients with heart failure with mildly reduced or preserved ejection fraction enrolled in the DELIVER trial.European Journal of Heart Failure, 25(12), pp. 2177-2188. (doi: 10.1002/ejhf.3043) (PMID:37771274)

Abstract

Introduction: COVID-19 may affect clinical risk in patients with heart failure. DELIVER began before and was conducted during the COVID-19 pandemic. Objective: We evaluated the association between COVID-19 and outcomes among DELIVER participants. Methods: Participants with chronic HFmrEF/HFpEF were randomized to dapagliflozin or placebo across 350 sites in 20 countries. COVID-19 was investigator-reported and the contribution of COVID-19 to death was centrally adjudicated. We assessed (1) incidence of COVID-19, (2) event rates before/during the pandemic, and (3) risks of death after diagnosis compared to death in participants without COVID-19. Further, we performed a sensitivity analysis assessing treatment effects censored at pandemic onset. Results: Of 6263 participants, 589 (9.4%) developed COVID-19, of whom 307 (52%) required/prolonged hospitalization. 155 deaths (15% of all deaths) were adjudicated as definitely/possibly COVID-19 related. COVID-19 cases and deaths did not differ by randomized assignment. Death-rate in the 12-months following diagnosis was 56.1 (95% CI:48.0 to 65.6) vs. 6.4 (95% CI:6.0–6.8)/100-participant-years among trial participants with versus without COVID-19 (aHR:8.60,95% CI:7.18–10.30). Risk was highest 0–3 months following diagnosis (153.5,95% CI:130.3–180.8) and remained elevated at 3–6 months (12.6,95% CI:6.6–24.3/100-participant-years). After excluding investigator reported fatal COVID-19 events, all-cause death rates in the 12 months following diagnosis among COVID-19 survivors (n = 458) remained higher (aHR: 2.46, 95% CI: 1.83 to 3.33) than all trial participants from randomization, with censoring of participants who developed COVID-19 at the time of diagnosis. Dapagliflozin reduced the CV death/worsening HF events when censoring participants at COVID-19 diagnosis (HR:0.81,95%CI:0.72–0.91) and pandemic onset (HR:0.72,95%CI:0.58–0.89). There were no DKA or major hypoglycemic events within 30-days of COVID-19. Conclusion: DELIVER is one of the most extensive experiences with COVID-19 of any cardiovascular trial, with >75% of follow-up time occurring during the pandemic. COVID-19 was common, with >50% of cases leading to hospitalization or death. Treatment benefits of dapagliflozin persisted when censoring at COVID-19 diagnosis and pandemic onset. Patients surviving COVID-19 event had a high early residual risk.

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