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Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements.
Clin Drug Investig. 2020 Jun 30 [Online ahead of print]CD

Abstract

BACKGROUND AND OBJECTIVE

Current guidelines recommend anticoagulation with a vitamin K antagonist (warfarin) after a bioprosthetic valve replacement. There is minimal literature evaluating direct oral anticoagulants (DOACs) in patients who have just received a bioprosthetic aortic valve replacement (AVR) or mitral valve replacement (MVR). The purpose of this study was to investigate any differences in efficacy and safety for patients taking a DOAC, compared with warfarin, after a bioprosthetic AVR or MVR.

METHODS

A retrospective cohort study was performed to evaluate anticoagulation in patients who received bioprosthetic valve replacements at a large teaching hospital from 2014 to 2018. Patients included in this study received either warfarin or a DOAC following bioprosthetic AVR or MVR, and were maintained on the same agent throughout the 6-month follow-up period. The primary efficacy outcome was the incidence of thromboembolic complications and the primary safety outcome was the incidence of major bleeding within 6 months following surgery. The rate of readmission was assessed as a secondary endpoint.

RESULTS

A total of 197 patients were included; 70 patients received warfarin and 127 patients received a DOAC (apixaban, n = 86; rivaroxaban, n = 40; dabigatran, n = 1). Three patients experienced thromboembolic events, all of which occurred in the DOAC group (0% vs. 2.4%; p = 0.20). Major bleeding occurred in 11 patients-two in the warfarin group and nine in the DOAC group (2.9% vs. 7.1%; p = 0.22). Sixty-one patients were readmitted within the 6-month time frame, with 26 readmissions in the warfarin group and 35 readmissions in the DOAC group (37% vs. 27%; p = 0.16).

CONCLUSIONS

This small, exploratory study found similar rates of thromboembolic complications and major bleeding events in patients who received a DOAC versus warfarin after a recent bioprosthetic AVR or MVR. This study was limited by its retrospective nature and its sample size. Larger, randomized controlled trials are needed to further determine the efficacy and safety of DOACs in this patient population.

Authors+Show Affiliations

Department of Pharmacy, ChristianaCare, Newark, DE, USA. spasciolla@usciences.edu. Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA, USA. spasciolla@usciences.edu.Department of Pharmacy, ChristianaCare, Newark, DE, USA.Department of Pharmacy, ChristianaCare, Newark, DE, USA.Department of Pharmacy, ChristianaCare, Newark, DE, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32607688

Citation

Pasciolla, Stacy, et al. "Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements." Clinical Drug Investigation, 2020.
Pasciolla S, Zizza LF, Le T, et al. Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements. Clin Drug Investig. 2020.
Pasciolla, S., Zizza, L. F., Le, T., & Wright, K. (2020). Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements. Clinical Drug Investigation. https://doi.org/10.1007/s40261-020-00939-x
Pasciolla S, et al. Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements. Clin Drug Investig. 2020 Jun 30; PubMed PMID: 32607688.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements. AU - Pasciolla,Stacy, AU - Zizza,Laura Falconieri, AU - Le,Thuy, AU - Wright,Kesha, Y1 - 2020/06/30/ PY - 2020/7/2/entrez JF - Clinical drug investigation JO - Clin Drug Investig N2 - BACKGROUND AND OBJECTIVE: Current guidelines recommend anticoagulation with a vitamin K antagonist (warfarin) after a bioprosthetic valve replacement. There is minimal literature evaluating direct oral anticoagulants (DOACs) in patients who have just received a bioprosthetic aortic valve replacement (AVR) or mitral valve replacement (MVR). The purpose of this study was to investigate any differences in efficacy and safety for patients taking a DOAC, compared with warfarin, after a bioprosthetic AVR or MVR. METHODS: A retrospective cohort study was performed to evaluate anticoagulation in patients who received bioprosthetic valve replacements at a large teaching hospital from 2014 to 2018. Patients included in this study received either warfarin or a DOAC following bioprosthetic AVR or MVR, and were maintained on the same agent throughout the 6-month follow-up period. The primary efficacy outcome was the incidence of thromboembolic complications and the primary safety outcome was the incidence of major bleeding within 6 months following surgery. The rate of readmission was assessed as a secondary endpoint. RESULTS: A total of 197 patients were included; 70 patients received warfarin and 127 patients received a DOAC (apixaban, n = 86; rivaroxaban, n = 40; dabigatran, n = 1). Three patients experienced thromboembolic events, all of which occurred in the DOAC group (0% vs. 2.4%; p = 0.20). Major bleeding occurred in 11 patients-two in the warfarin group and nine in the DOAC group (2.9% vs. 7.1%; p = 0.22). Sixty-one patients were readmitted within the 6-month time frame, with 26 readmissions in the warfarin group and 35 readmissions in the DOAC group (37% vs. 27%; p = 0.16). CONCLUSIONS: This small, exploratory study found similar rates of thromboembolic complications and major bleeding events in patients who received a DOAC versus warfarin after a recent bioprosthetic AVR or MVR. This study was limited by its retrospective nature and its sample size. Larger, randomized controlled trials are needed to further determine the efficacy and safety of DOACs in this patient population. SN - 1179-1918 UR - https://www.unboundmedicine.com/medline/citation/32607688/Comparison_of_the_Efficacy_and_Safety_of_Direct_Oral_Anticoagulants_and_Warfarin_After_Bioprosthetic_Valve_Replacements L2 - https://dx.doi.org/10.1007/s40261-020-00939-x DB - PRIME DP - Unbound Medicine ER -
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