tetano
Editor, Senior Moderator
Eur J Heart Fail
. 2023 Sep 28.
doi: 10.1002/ejhf.3043. Online ahead of print. Impact of COVID-19 in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction Enrolled in the DELIVER Trial
Ankeet S Bhatt[SUP] 1 [/SUP], Mikhail N Kosiborod[SUP] 2 [/SUP], Brian L Claggett[SUP] 3 [/SUP], Zi Michael Miao[SUP] 3 [/SUP], Muthiah Vaduganathan[SUP] 3 [/SUP], Carolyn S P Lam[SUP] 4 [/SUP], Adrian F Hernandez[SUP] 5 [/SUP], Felipe A Martinez[SUP] 6 [/SUP], Silvio E Inzucchi[SUP] 7 [/SUP], Sanjiv J Shah[SUP] 8 [/SUP], Rudolf A de Boer[SUP] 9 [/SUP], Pardeep S Jhund[SUP] 10 [/SUP], Akshay S Desai[SUP] 3 [/SUP], James C Fang[SUP] 11 [/SUP], Yaling Han[SUP] 12 [/SUP], Josep Comin-Colet[SUP] 13 [/SUP], Jarosław Drożdż[SUP] 14 [/SUP], Orly Vardeny[SUP] 15 [/SUP], Bela Merkely[SUP] 16 [/SUP], Daniel Lindholm[SUP] 17 [/SUP], Magnus Peterson[SUP] 17 [/SUP], Anna Maria Langkilde[SUP] 17 [/SUP], John J V McMurray[SUP] 10 [/SUP], Scott D Solomon[SUP] 3 [/SUP]
Affiliations
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. This article is protected by copyright. All rights reserved.
Keywords: coronavirus disease-2019; death; heart failure.
. 2023 Sep 28.
doi: 10.1002/ejhf.3043. Online ahead of print. Impact of COVID-19 in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction Enrolled in the DELIVER Trial
Ankeet S Bhatt[SUP] 1 [/SUP], Mikhail N Kosiborod[SUP] 2 [/SUP], Brian L Claggett[SUP] 3 [/SUP], Zi Michael Miao[SUP] 3 [/SUP], Muthiah Vaduganathan[SUP] 3 [/SUP], Carolyn S P Lam[SUP] 4 [/SUP], Adrian F Hernandez[SUP] 5 [/SUP], Felipe A Martinez[SUP] 6 [/SUP], Silvio E Inzucchi[SUP] 7 [/SUP], Sanjiv J Shah[SUP] 8 [/SUP], Rudolf A de Boer[SUP] 9 [/SUP], Pardeep S Jhund[SUP] 10 [/SUP], Akshay S Desai[SUP] 3 [/SUP], James C Fang[SUP] 11 [/SUP], Yaling Han[SUP] 12 [/SUP], Josep Comin-Colet[SUP] 13 [/SUP], Jarosław Drożdż[SUP] 14 [/SUP], Orly Vardeny[SUP] 15 [/SUP], Bela Merkely[SUP] 16 [/SUP], Daniel Lindholm[SUP] 17 [/SUP], Magnus Peterson[SUP] 17 [/SUP], Anna Maria Langkilde[SUP] 17 [/SUP], John J V McMurray[SUP] 10 [/SUP], Scott D Solomon[SUP] 3 [/SUP]
Affiliations
- PMID: 37771274
- DOI: 10.1002/ejhf.3043
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. This article is protected by copyright. All rights reserved.
Keywords: coronavirus disease-2019; death; heart failure.