| Summary: | The populations included
in the randomized controlled clinical trials and observational studies were
different. The effectiveness and safety of rivaroxaban for stroke prevention in
patients with atrial fibrillation (AF) varied among studies. This study aimed to
estimate the real-world outcomes of rivaroxaban in patients with AF accurately. A
discrete event simulation (DES) was used to predict the counterfactual results of
the ROCKET AF study. The hypothetical cohorts of patients were generated using
Monte Carlo simulation according to the baseline covariate distributions that
matched the marginal distribution of covariates reported in the ROCKET AF and
three observational studies. The DES model structure was constructed based on
a priori knowledge about disease progression and possible
outcomes of patients with AF. The DES model accurately replicated the overall
results of the ROCKET AF study. Both predicted stroke/systematic embolism (SE)
and major bleeding rates were lower in the three observational studies than in
the simulated ROCKET AF study. The risk difference of stroke/SE and major
bleeding was not significant among the predicted outcomes of the three
observational studies. Although some differences existed in the absolute rates of
stroke/SE and major bleeding between observed and simulated studies, the results
confirmed that rivaroxaban was noninferior to warfarin for the prevention of
stroke/systematic embolism with no significance in the risk of major bleeding in
large AF populations, which was similar to the results of ROCKET AF.
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