Real‐World Comparative Effectiveness and Safety of Non‐Vitamin K Antagonist Oral Anticoagulants vs. Warfarin in a Developing Country

Abstract

We aimed to compare effectiveness and safety of the non‐vitamin K antagonist oral anticoagulants (NOACs) vs. warfarin for stroke prevention in nonvalvular atrial fibrillation (NVAF) in a developing country where anticoagulation control with warfarin is suboptimal. A real‐world study was conducted among patients with NVAF in Thailand receiving NOACs and warfarin from 9 hospitals during January 2012 to April 2018. Propensity‐score weighting was used to balance covariates across study groups. Cox regression models were used to compare the risk of thromboembolism, major bleeding, and net adverse clinical events across matched cohorts. A total of 2,055 patients; 605, 604, 441, and 405 patients receiving warfarin, rivaroxaban, dabigatran, and apixaban, respectively, were included. Median (interquartile range) time in therapeutic range (TTR) for warfarin users was 49.5% (26.6%–70.3%). Compared with warfarin, NOACs were associated with a significant reduction in major bleeding either when analyzed as a group (adjusted hazard ratio (HR) (95% confidence interval (CI)) of 0.46 (0.34–0.62) or by each agent. Compared with warfarin users with poor TTR, apixaban (adjusted HR 0.48, 95% CI 0.26–0.86, P = 0.013) and dabigatran (adjusted HR 0.44, 95% CI 0.21–0.90, P = 0.025) were associated with a lower risk of thromboembolism, in addition to markedly lower risk of major bleeding. In a healthcare system where anticoagulation control with warfarin is suboptimal, use of NOACs was associated with a profound reduction in major bleeding. The effectiveness and safety advantages of NOACs were more pronounced compared with warfarin users with low TTR.

Effectiveness and Safety of Apixaban in over 3.9 Million People with Atrial Fibrillation: A Systematic Review and Meta-Analysis

“…Apixaban was associated with a significantly lower rates of ICH compared to VKAs (RR 0.49, 95% CI 0.41-0.59, I 2 = 81%) and rivaroxaban (RR 0.71, 95% CI 0.61-0.84, I 2 = 74%), but not dabigatran (RR 0.98, 95% CI 0.83-1.16, I 2 = 34%). [18,20,[23][24][25][26][27][28]30,31,[33][34][35]37,[39][40][41][42]44,[46][47][48]50,52,53].…”

Using real world evidence to generate cost-effectiveness analysis of fibrinolytic therapy in patients with ST-segment elevation myocardial infarction in Thailand

“… 38 Disparity on the developmental stages of the health system among high-income countries versus LMIC can potentially lead to differences in drug performance. 39 , 40 As a result, a cost effectiveness analysis may be more applicable to a health system if the local data are used as input parameters. 41 Real-world evidence has been recognized for its strength in answering the actual questions based on real-world data and widely encouraged in informing treatment reimbursement decision-making.…”

Benefits and Harms of Low-Dose Rivaroxaban in Asian Patients With Atrial Fibrillation: A Systematic Review and Meta-analysis of Real-World Studies

“…This difference might be partially explained by the control of time in therapeutic range (TTR), a critical indicator reflecting the anticoagulation effect for patients treated with warfarin and usually being well controlled during the management of RCTs. Nevertheless, TTR is hard to do well in real-world practice for multiple factors, such as frequent interactions with various diet or concomitant medications, genetic differences in metabolic or pharmacodynamic features among patients, insufficient management of anticoagulants, and lack of compliance in warfarin therapy, subsequently leading to poor clinical outcomes ( Mitsuntisuk et al, 2020 ). Thus, Asian AF patients under warfarin treatment and with poor control of TTR might also be benefit from low-dose rivaroxaban.…”