Simulation of anticoagulation in atrial fibrillation patients with
rivaroxaban --- from trial to target population
Abstract
Aim The population included in randomized controlled clinical trial of
ROCKET AF and observational studies were different, and the
effectiveness and safety of rivaroxaban in stroke prevention of atrial
fibrillation (AF) varied among studies. The aim of this study was to
estimate the real-world outcomes of rivaroxaban in AF patients in a
relatively accurate way. Methods A discrete event simulation (DES) model
was proposed to predict the counterfactual outcomes of ROCKET AF that
would have it been conducted in broader observational study populations.
The hypothetical cohorts of patients were generated using Monte Carlo
simulation. The DES model structure was built based on disease
progression and possible outcomes of AF. Cardiovascular events were
recorded during the simulated two-year follow-up period. Results The
results showed lower predicted rates of stroke/ systemic embolism (SE)
and major bleeding in three observational studies than those in
simulated ROCKET AF. The simulated stroke/SE incidence was 1.097-1.318
per 100 patient-years and simulated major bleeding incidence was
2.804-3.238 per 100 patient-years in observational studies. The risk
difference of stroke/SE and major bleeding was similar among predicted
outcomes of the three observational studies. Most simulated hazard
ratios (HRs) were close to the corresponding observed HRs. Conclusion
The simulated incidence of stroke/SE incidence and major bleeding might
reflect the real-world event rate in AF patients. Even some differences
existed in the absolute rates of stroke/SE and major bleeding between
observed and simulated studies, the results confirmed similar
effectiveness and safety to ROCKET AF comparing rivaroxaban and warfarin
in AF patients.