Prediction of inclisiran efficacy in patients with established atherosclerotic cardiovascular disease: the SIRIUS in-silico modelling of cardiovascular outcomes
Authors' conclusion
SIRIUS is the first in-silico simulation using a knowledge-based mechanistic model to predict the efficacy of LLT on cardiovascular outcomes in ASCVD.
Study context
- Population
- Virtual patients with established atherosclerotic cardiovascular disease (ASCVD) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL
- Participants
- 204,691 virtual patients
- Comparison
- Inclisiran vs placebo, adjunct to high-intensity statin ± ezetimibe
- Outcome
- 3-point major adverse cardiovascular event (MACE) (predicted)
- Follow-up
- 5 years
Methodological detailsmechanistic simulation, virtual population, each virtual patient as own control, 5-year simulation
- Mechanistic simulation
- Virtual population
- Each virtual patient as own control
- 5-year simulation
Main finding
As reported in the abstract
Relative risk reduction
25.2%
By group
Further findings
MI · 5 years · predicted relative reduction 34.8%
HR 0.65
Ischaemic stroke · 5 years · predicted relative reduction 26%
HR 0.74
Major adverse limb event · 5 years · predicted relative reduction 34.1%
HR 0.66
LDL-C
- Predicted LDL-C reduction with inclisiran vs placebo (from 91.1 to 48.3 mg/dL)
- 49.7%
CV death
- Predicted relative reduction of CV death
- 7.1%
- 4.2% vs. 4.5%; HR 0.93
Original publication
Prediction of inclisiran efficacy in patients with established atherosclerotic cardiovascular disease: the SIRIUS in-silico modelling of cardiovascular outcomes. Eur J Prev Cardiol. Published 26 December 2025. doi:10.
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