Association of Cardiac Biomarkers With Major Adverse Cardiovascular Events in High-risk Patients With Diabetes: A Secondary Analysis of the DECLARE-TIMI 58 Trial

Zelniker, TA; Wiviott, SD; Mosenzon, O; Goodrich, EL; Jarolim, P; Cahn, A; Bhatt, DL; Leiter, LA; McGuire, DK; Wilding, J; Averkov, O; Budaj, A; Parkhomenko, A; Ray, KK; Gause-Nilsson, I; Langkilde, AM; Fredriksson, M; Raz, I; Sabatine, MS; Morrow, DA

doi:10.1001/jamacardio.2023.0019

Cardiometabolic & kidney

Association of Cardiac Biomarkers With Major Adverse Cardiovascular Events in High-risk Patients With Diabetes: A Secondary Analysis of the DECLARE-TIMI 58 Trial

JAMA CardiolPublished 1 May 2023Secondary analysis of the DECLARE-TIMI 58 randomised trial

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Authors' conclusion

In this study, NT-proBNP and hsTnT levels were associated with the risk for future cardiovascular events in both primary and secondary prevention patients with T2D. Both cardiac biomarkers were helpful to identify patients at very high risk for atherosclerotic events that may derive reduction in risk of MACE with dapagliflozin.

Study context

Population: Patients with T2D and multiple risk factors for atherosclerotic cardiovascular disease (ASCVD) (≈60%) or established ASCVD (≈40%), with blood samples at randomisation
Participants: 14,565 patients

Comparison: Dapagliflozin vs placebo, by baseline NT-proBNP and hsTnT
Primary endpoint: MACE:
MI
Ischemic stroke
CV death

Primary result

As reported in the abstract

MACE, association with biomarkers (aHR per 1 SD in log-transformed biomarker)

NT-proBNP, individually: aHR

1.62

95% CI 1.49–1.76

hsTnT, individually: aHR

1.59

95% CI 1.46–1.74

NT-proBNP, both in model: aHR

1.46

95% CI 1.34–1.60

hsTnT, both in model: aHR

1.39

95% CI 1.26–1.53

Further findings

Outcome	← Lower risk with dapagliflozin ←→ Higher risk with dapagliflozin →	HR (95% CI)
MACE, dapagliflozin vs placebo, top biomarker quartileDapagliflozinvs PlaceboNT-proBNP top quartile; ARR 2.4% · nominally lower	0.512	0.83 (0.71–0.97)
MACE, dapagliflozin vs placebo, top biomarker quartileDapagliflozinvs PlacebohsTnT top quartile; ARR 2.7% · nominally lower	0.512	0.85 (0.72–0.99)
MACE, dapagliflozin vs placebo, biomarker quartiles 1 to 3Dapagliflozinvs PlaceboNT-proBNP Q1–3; ARR 0%	0.512	1.02 (0.88–1.18)
MACE, dapagliflozin vs placebo, biomarker quartiles 1 to 3Dapagliflozinvs PlacebohsTnT Q1–3; ARR 0.2%	0.512	0.97 (0.84–1.13)
	0.512Hazard ratio (log scale)

Major adverse cardiovascular events (MACE) association, established ASCVD (subgroup)

NT-proBNP: aHR: 1.60 (95% CI 1.45-1.77)
hsTnT: aHR: 1.62 (95% CI 1.45-1.81)

MACE association, multiple risk factors for ASCVD (subgroup)

NT-proBNP: aHR: 1.62 (95% CI 1.40-1.88)
hsTnT: aHR: 1.51 (95% CI 1.29-1.77)

Effect modification by continuous baseline biomarker levels

Baseline biomarker levels did not modify the relative treatment effect of dapagliflozin vs placebo with MACE

Original publication

Association of Cardiac Biomarkers With Major Adverse Cardiovascular Events in High-risk Patients With Diabetes: A Secondary Analysis of the DECLARE-TIMI 58 Trial. JAMA Cardiol. Published 1 May 2023. doi:10.1001/jamacardio.2023.0019

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