IMR Press / RCM / Volume 22 / Issue 3 / DOI: 10.31083/j.rcm2203111
Open Access Original Research
Simulation of anticoagulation in atrial fibrillation patients with rivaroxaban—from trial to target population
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1 Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, 200127 Shanghai, China
2 School of Medicine, Tongji University, 200092 Shanghai, China
3 Shanghai Anticoagulation Pharmacist Alliance, Shanghai Pharmaceutical Association, 200040 Shanghai, China
4 Department of S/4HANA Research & Development, SAP (China) Co., Ltd., 201203 Shanghai, China

These authors contributed equally.

Rev. Cardiovasc. Med. 2021 , 22(3), 1019–1027; https://doi.org/10.31083/j.rcm2203111
Submitted: 29 June 2021 | Revised: 3 August 2021 | Accepted: 16 August 2021 | Published: 24 September 2021
Copyright: © 2021 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/).
Abstract

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.

Keywords
Rivaroxaban
Atrial fibrillation (AF)
Simulation
Randomized controlled trial (RCT)
Observational study
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