Retrospective Review on the Safety and Efficacy of Direct Oral Anticoagulants Compared With Warfarin in Patients With Cirrhosis

Kaitlyn Jones; Caroline Pham; Christine Aguilar; Shaila Sheth

doi:10.12788/fp.0058

Retrospective Review on the Safety and Efficacy of Direct Oral Anticoagulants Compared With Warfarin in Patients With Cirrhosis

Fed Pract. 2020 Oct;37(10):479-485. doi: 10.12788/fp.0058.

Authors

Kaitlyn Jones¹, Caroline Pham¹, Christine Aguilar¹, Shaila Sheth¹

Affiliation

¹ is a Clinical Pharmacy Specialist in Primary Care at the University of Kansas Health System in Kansas City, Kansas. , and 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.

Abstract

Purpose: Patients with cirrhosis needing anticoagulation therapy have historically been prescribed warfarin. New retrospective research has concluded that in patients with cirrhosis direct oral anticoagulants (DOACs) have similar or lower bleeding rates compared with that of warfarin. This study compares the safety and efficacy of DOACs with that of warfarin in patients with cirrhosis.

Methods: A retrospective chart review was conducted in adult patients with cirrhosis taking either apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin. Exclusion criteria consisted of patients prescribed triple antithrombotic therapy (dual antiplatelet therapy plus an anticoagulant) and indications other than nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). The primary endpoint was all-cause bleeding, and the secondary endpoints were failed efficacy and major bleeding as defined by the International Society on Thrombosis and Haemostasis in 2005. Failed efficacy was a combination endpoint including the development of VTE, stroke, myocardial infarction and/or death. Patient data were collected from the Computerized Patient Record System from October 31, 2014 to October 31, 2018.

Results: The study included 42 patients in the DOAC group and 37 patients in the warfarin group. Baseline characteristics were not significantly different between groups except for the Child-Turcotte-Pugh score, Model for End-Stage Liver Disease score, international normalized ratio, and number of days on anticoagulation therapy. The rate of all-cause bleeding in the DOAC group was 16.7% (n = 7) vs 21.6% (n = 8) in the warfarin group (P = .7). The rate of major bleeding in the DOAC group was 2.4% (n = 1) vs 5.4% (n = 2) in the warfarin group (P = .6). The rate of failed efficacy in the DOAC group was 7.1% (n = 3) compared with 8.1% (n = 3) in the warfarin group (P = .9). Subgroup analysis of allcause bleeding did not identify any significant trends between groups.

Conclusions: There were no statistically significant differences identified between the rates of all-cause bleeding, major bleeding, and failed efficacy between the DOACs 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.