Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation

Abstract

T he use of oral anticoagulants (OACs), such as the vitamin K antagonists (eg, warfarin), in patients with atrial fibrillation (AF) results in a significant reduction in stroke, ischemic stroke (IS), and systematic thromboembolism (TE), as well as all-cause mortality, when compared with placebo or control.1 However, warfarin has many limitations, including the necessity for regular anticoagulation monitoring, dietary and drug interactions, and the potential for serious bleeding if anticoagulation is poorly controlled, as reflected by a poor time in therapeutic range. 2 The availability of the non-vitamin K antagonist oral anticoagulants (NOACs) has changed the landscape for stroke prevention in AF, and a meta-analysis of randomized clinical trials (RCTs) by Ruff et al 3 has shown that usual-dose NOACs result in a significant reduction in stroke/TE and mortality with NOACs compared with warfarin, with a trend toward less major bleeding and significantly lower intracranial hemorrhage (ICH). However, RCTs have specific inclusion/ exclusion criteria, have set protocol-based follow-up, and perhaps represent a highly selected and controlled scenario, but still represent the gold standard of testing the effectiveness and safety of an intervention. Based on RCT data, indirect comparisons have been published showing how the different NOACs may perform relative to each other, 4,5 but only a headto-head RCT can definitively assess the relative efficacy and safety of one NOAC against another.When a drug is licensed and used in everyday clinical practice, these drugs are then prescribed to a broad spectrum of Background and Purpose-This study was designed to evaluate the effectiveness and safety of rivaroxaban in real-world practice compared with effectiveness and safety of dabigatran or warfarin for stroke prevention in atrial fibrillation through meta-analyzing observational studies. Methods-Seventeen studies were included after searching in PubMed for studies reporting the comparative effectiveness and safety of rivaroxaban versus dabigatran (n=3), rivaroxaban versus Warfarin (n=11), or both (n=3) for stroke prevention in atrial fibrillation. Results-Overall, the risks of stroke/systematic thromboembolism with rivaroxaban were similar when compared with those with dabigatran (stroke/thromboembolism: hazard ratio, 1.02; 95% confidence interval, 0.91-1.13; I 2 =70.2%, N=5), but were significantly reduced when compared with those with warfarin (hazard ratio, 0.75; 95% confidence interval, 0.64-0.85; I 2 =45.1%, N=9). Major bleeding risk was significantly higher with rivaroxaban than with dabigatran (hazard ratio, 1.38; 95% confidence interval, 1.27-1.49; I 2 =26.1%, N=5), but similar to that with warfarin (hazard ratio, 0.99; 95% confidence interval, 0.91-1.07; I 2 =0.0%, N=6). Rivaroxaban was associated with increased all-cause mortality and gastrointestinal bleeding, but similar risk of acute myocardial infarction and intracranial hemorrhage when compared with dabigatran. When compared with warfarin, rivaroxaban was ass...

Standard and reduced doses of dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation: a nationwide cohort study

“…In our study, rivaroxaban was associated with a higher risk of major bleeding compared with dabigatran or apixaban. The previously discussed American studies and a recently published meta‐analysis also found an increased risk of bleeding associated with rivaroxaban compared with dabigatran . Two Danish studies by Larsen et al .…”

How to Reduce Gastrointestinal Bleeding Risk on Anticoagulation Therapy in Non-Valvular Atrial Fibrillation?

“…В недавно проведенном наблюдатель-ном сравнительном "head-to-head" исследовании, в которое был включен 118891 пациент с неклапан-ной ФП в возрасте 65 лет и старше, терапия риваро-ксабаном сопровождалась более высоким риском больших ЖК кровотечений в сравнении с дабигатра-ном в дозе 150 мг 2 раза в день (отношений риска 1,40) [13]. В мета-анализе, проведенном Bai Y, et al, при сравнительном исследовании дабигатрана и ривароксабана установлено, что ЖК кровотечения чаще возникают на фоне применения ривароксабана, причем это различие было характерно как для высо-ких, так и для низких доз сравниваемых препаратов [14]. В проведенном нами исследовании не установ-лено различий в частоте применения НОАК у боль-ных с наличием и отсутствием патологии пищевода, желудка и 12-перстной кишки (17,0% и 19,6%, соот-ветственно).…”

Direct Oral Anticoagulants in Nonvalvular Atrial Fibrillation: Practical Considerations on the Choice of Agent and Dosing

“…In a recent meta-analysis of 17 observational studies comparing rivaroxaban, dabigatran, and warfarin, rivaroxaban was as efficacious as dabigatran for the prevention of stroke or systemic embolism (hazard ratio [HR] 1.02; 95% CI 0.91-1.13), but it was associated with an increased risk of major bleeding (HR 1.38; 95% CI 1.27-1.49), gastrointestinal bleeding (HR 1.33; 95% CI 1.18-1.48), and all-cause mortality (HR 1.23; 95% CI 1.12-1.33) when compared with dabigatran [14]. However, there was no difference between the 2 agents in the risk of acute myocardial infarction or intracranial hemorrhage.…”