Secondary analysis
Association of Cardiac Biomarkers With Major Adverse Cardiovascular Events in High-risk Patients With Diabetes
- Secondary analysis of the DECLARE-TIMI 58 randomised trial
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) (approximately 60%) or established ASCVD (approximately 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
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 | HR (95% CI) | |
|---|---|---|
| MACE, dapagliflozin vs placebo, top biomarker quartile — Dapagliflozin vs Placebo · NT-proBNP top quartile; ARR 2.4% · nominally lower | 0.83 (0.71–0.97) | |
| MACE, dapagliflozin vs placebo, top biomarker quartile — Dapagliflozin vs Placebo · hsTnT top quartile; ARR 2.7% · nominally lower | 0.85 (0.72–0.99) | |
| MACE, dapagliflozin vs placebo, biomarker quartiles 1 to 3 — Dapagliflozin vs Placebo · NT-proBNP Q1–3; ARR 0% | 1.02 (0.88–1.18) | |
| MACE, dapagliflozin vs placebo, biomarker quartiles 1 to 3 — Dapagliflozin vs Placebo · hsTnT Q1–3; ARR 0.2% | 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
Summarised from the published abstract; every number is checked against it