Kaitlyn Jones is a Clinical Pharmacy Specialist in Primary Care at the University of Kansas Health System in Kansas City, Kansas. Caroline Pham, Shaila Sheth, and Christine Aguilar are Clinical Pharmacy Specialists in Internal Medicine at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. Caroline Pham, Christine Aguilar, and Shaila Sheth are Clinical Instructors at the Baylor College of Medicine in Houston. Correspondence: Kaitlyn Jones (kaitlynjo8029@gmail.com)
Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.
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The inability to meet power or evaluate adherence and appropriate renal dose adjustments for DOACs limited this study. This study was conducted at a single center in a predominantly male veteran population and therefore may not be generalizable to other populations. A majority of patients in the DOAC group were prescribed apixaban (69.1%), which may have affected the overall rate of major bleeding in the DOAC group. Pivotal trials of apixaban have shown a consistent decreased risk of major bleeding in patients with NVAF or VTE when compared with warfarin.14,15 Therefore, the results of this study may not be generalizable to all DOACs.
An inherent limitation of this study was the inability to collect data verifying adherence in the DOAC group. However, in the warfarin group, percentage of time within the therapeutic INR range of 2 to 3 was collected. While not a direct marker of adherence, this does allow for limited evaluation of therapeutic efficacy and safety within the warfarin group. Last, proper dosing of DOACs in patients with and without adequate renal function was not evaluated in this study.
Conclusions
The results of this study are consistent with other retrospective research and literature reviews. There were no statistically significant differences identified between the rates of all-cause bleeding, major bleeding, and failed efficacy between the DOAC and warfarin groups. DOACs may be a safe alternative to warfarin in patients with cirrhosis requiring anticoagulation for NVAF or VTE, but large randomized trials are required to confirm these results.