Real-world clinical evidence on rivaroxaban, dabigatran, and apixaban compared with vitamin K antagonists in patients with nonvalvular atrial fibrillation: a systematic literature review

ABSTRACT

Introduction: Several comparative real-world effectiveness studies on direct oral anticoagulants (DOACs) have been conducted, but an overview of the available evidence remains to be developed, which could provide a better understanding of the value of DOACs relative to vitamin K antagonists (VKAs).

Areas covered: A systematic literature review was conducted on the available real-world evidence (RWE) of three DOACs (rivaroxaban, dabigatran, and apixaban) compared with VKAs (e.g. warfarin), in patients with nonvalvular atrial fibrillation (NVAF).This systematic literature review included RWE published up to December 2016. Studies with > 50 patients reporting on incident and prevalent NVAF cases were included. The following databases were searched: Medline, Embase, and the Cochrane Library. Outcomes of interest included thromboembolic events, all-cause mortality, bleeding events, and non-persistence. Of the 562 RWE DOACs articles retrieved, 49 presented results for rivaroxaban versus VKAs, 79 for dabigatran versus VKAs, and 18 for apixaban versus VKAs. Substantial heterogeneity was found across patient population, outcome definition, and follow-up period. Major bleeding, ischemic stroke, and intracranial hemorrhage were the most frequent outcomes analyzed.

Expert commentary: Overall, the RWE studies were aligned with the Phase 3 trials. However, conflicting results were reported for several outcomes of interest.

KEYWORDS:

• Anticoagulation
• direct oral anticoagulants
• nonvalvular atrial fibrillation
• real-world evidence
• stroke prevention

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Declaration of Interest

JB Briere, and K Folkerts are employees of Bayer AG; K Bowrin is employee of Bayer Plc. CI Coleman, P Levy and O Wu were paid by Bayer AG as a consultant who provided critical input for the study design and interpretation of results. V Taieb and A Millier are employees of Creativ-ceutical who received funding from Bayer AG. M Toumi was paid by creativ-Ceutical as a consultant who provided critical input for the study design and interpretation of the results.

Reviewer Disclosures

A reviewer on this manuscript has disclosed that they are the CEO and founder of QUALIblood sa and reports personal fees from Stago, Roche Diagnostics, Roche and Daiichi‐Sankyo.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This work was supported by Bayer AG and Creativ-Ceutical, with funding from Bayer AG.