Heart failure & cardiomyopathies
Impact of Vutrisiran on Cardiac Biomarkers in Patients With Transthyretin Amyloidosis With Cardiomyopathy From HELIOS-B
Primary result · NT-proBNP, change from baselineResult — go to the resultGeometric mean fold-change ratio 0.68 95% CI 0.61–0.76Authors' conclusion
Patterns of associations between biomarkers and adverse outcomes support the importance of early treatment initiation and the potential for risk reduction in patients with ATTR-CM. Vutrisiran maintained stable or reduced levels of both biomarkers consistent with the benefit of treatment in reducing the risk of cardiovascular events and all-cause mortality.
Study context
- Population
- Patients with ATTR-CMrandomised 1:1
- Participants
- 655 patients
- Comparison
- Vutrisiran vs placebo
- Primary endpoint
- Composite of:
- All-cause mortality
- Recurrent CV events
Methodological detailsdouble-blind, placebo-controlled, prespecified exploratory endpoints, HELIOS-B primary endpoint: composite of all-cause mortality and recurrent CV events; all-cause mortality through 42 months secondary
- Double-blind
- Placebo-controlled
- Prespecified exploratory endpoints
- HELIOS-B primary endpoint: composite of all-cause mortality and recurrent CV events; all-cause mortality through 42 months secondary
Primary result
NT-proBNP, change from baseline · month 30
Geometric mean fold-change ratio
0.68
95% CI 0.61–0.76
P < 0.0001
Change by group
Placebo
753
median change · IQR −8–2,573 · pg/mL
Vutrisiran
118
median change · IQR −419–911 · pg/mL
As reported in the abstract
Secondary outcomes
Median change, pg/mL
| Outcome | Vutrisiran | Placebo | Geometric mean fold-change ratio (95% CI) | P value |
|---|---|---|---|---|
| Troponin I, change from baseline · month 30 | −5.8 (IQR −25.0–10.0) | 9.7 (IQR −6.3–41.2) | 0.68 (0.62–0.75) | P < 0.0001 |
Baseline NT-proBNP and troponin I vs composite outcome and all-cause mortality
- Baseline NT-proBNP and troponin I independently associated with risks of composite outcome and all-cause mortality
- P < 0.0001
Month-6 biomarker changes vs outcomes
- Increases in NT-proBNP associated with higher risk of composite outcome and all-cause mortality
- Decreases in troponin I associated with lower risk of composite outcome
Original publication
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