Which dose of apixaban is suitable for Asian patients with atrial fibrillation who have a serum creatinine &lt; 1.5 mg/dL but an estimated glomerular filtration rate &lt; 50 mL/min?

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Abstract

Introduction

Reduced-dose (Low-dose [LD]) apixaban is recommended in patients with atrial fibrillation (AF) who fulfill 2 of 3 criteria: age ≥ 80 years, body weight ≤ 60 kg, and a serum creatinine (sCr) ≥ 1.5 mg/dl. However, the suitable (appropriate) dose for Asian patients who have a sCr < 1.5 mg/dl but an estimated glomerular filtration rate (eGFR) < 50 mL/min is unknown.

Methods

This is a retrospective study using the Chang Gung Memorial hospital medical database in Taiwan. A total of 13,508 AF patients receiving oral anticoagulants (OACs) from 2012 to 2018 were reviewed and 1595 patients with a sCr < 1.5 mg/dL and an eGFR < 50 mL/min who met 1 criterion of dose reduction of apixaban other than sCr (that is, age ≥ 80 years or body weight < 60 kg) were identified. Clinical outcomes were compared between LD and SD apixaban versus warfarin.

Results

Their OACs use was as follows: 343 receiving apixaban (128 patients on standard dose [SD] and 215 on LD), 174 receiving warfarin, and 1078 on other NOACs. Patients with an eGFR < 50 mL/min had higher risk of mortality (adjusted hazard ratio [aHR], 1.264; 95 % confidence interval [CI], 1.086–1.472) and composite endpoint of ‘ischemic stroke/systemic embolism (IS/SE) or major bleeding or mortality (aHR, 1.202; 95 % CI, 1.056–1.370) compared to those with an eGFR ≥ 50 mL/min whereas the risk of IS/SE and major bleeding were similar. LD apixaban was associated with lower risk of composite endpoint of IS/SE or major bleeding (aHR, 0.567; 95 % CI, 0.331 – 0.972), mortality (aHR, 0.336; 95 % CI, 0.138 – 0.815), and ‘IS/SE or major bleeding or mortality (aHR, 0.551; 95 % CI, 0343 – 0.886) compared to warfarin while the risk was comparable between SD apixaban and warfarin (aHR, 0.745; 95 % CI, 0.402 – 1.378; aHR, 0.407; 95 % CI, 0.145 – 1.143; aHR, 0.619; 95 % CI, 0.354 – 1.084, respectively).

Conclusion

In patients with sCr < 1.5 mg/dL and eGFR < 50 mL/min, SD and LD apixaban were comparable in the prevention of IS/SE, but LD apixaban was superior in reducing the composite endpoint of ‘IS/SE or major bleeding or mortality’. Therefore, LD apixaban might be a preferred dose for this population.

Related collections

Most cited references 15

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Prediction of Creatinine Clearance from Serum Creatinine

Donald W Cockcroft, Henry Gault (1976)

A formula has been developed to predict creatinine clearance (C cr ) from serum creatinine (S cr ) in adult males: Ccr = (140 – age) (wt kg)/72 × S cr (mg/100ml) (15% less in females). Derivation included the relationship found between age and 24-hour creatinine excretion/kg in 249 patients aged 18–92. Values for C cr were predicted by this formula and four other methods and the results compared with the means of two 24-hour C cr’s measured in 236 patients. The above formula gave a correlation coefficient between predicted and mean measured Ccr·s of 0.83; on average, the difference between predicted and mean measured values was no greater than that between paired clearances. Factors for age and body weight must be included for reasonable prediction.

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Apixaban versus Warfarin in Patients with Atrial Fibrillation

Christopher B Granger, John H Alexander, John J.V. McMurray … (2012)

Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).

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Manesh R Patel, Kenneth Mahaffey, Jyotsna Garg … (2012)

The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).

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Author and article information

Contributors

Tze-Fan Chao

Journal

Journal ID (nlm-ta): Int J Cardiol Heart Vasc

Journal ID (iso-abbrev): Int J Cardiol Heart Vasc

Title: International Journal of Cardiology. Heart & Vasculature

Publisher: Elsevier

ISSN (Electronic): 2352-9067

Publication date PMC-release: 25 December 2023

Publication date Collection: February 2024

Publication date (Electronic): 25 December 2023

Volume: 50

Electronic Location Identifier: 101333

Affiliations

[a ]Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan

[b ]Institute of Clinical Medicine, and Cardiovascular Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan

[c ]The Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan

[d ]College of Medicine, Chang Gung University, Taoyuan, Taiwan

[e ]Microscopy Core Laboratory, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan

[f ]Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; and Danish Center for Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

Author notes

[* ]Corresponding authors at: Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan. eyckeyck@ 123456gmail.com

[1]

Drs. Tsai and Liao are co-first authors.

[2]

Drs. Chan and Chao are co-corresponding authors.

Article

Publisher Item ID: S2352-9067(23)00164-1 Publisher ID: 101333

DOI: 10.1016/j.ijcha.2023.101333

PMC ID: 10899727

PubMed ID: 38419610

SO-VID: 1323ea78-87cd-4f05-92fd-b467bbbe9271

License:

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

History

Date received : 25 September 2023

Date revision received : 3 December 2023

Date accepted : 19 December 2023

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