Key result
On-label DOACs match warfarin for thromboembolism prevention regardless of renal function formula used.
Why the study?
The Cockcroft-Gault formula is recommended for DOAC dosing, but its performance varies with age, weight, and renal function, warranting comparison with the CKD-EPI and MDRD formulae.
Does the choice of renal function estimation formula for dosing DOACs affect clinical outcomes compared to warfarin in patients with atrial fibrillation?
Cohort (n=6,268)
No
Does the choice of renal function estimation formula for dosing DOACs affect clinical outcomes compared to warfarin in patients with atrial fibrillation?
Absolute Event Rate: 1.33% vs 1.35%
p-value: p=<0.001 for noninferiority
Although renal function formulae differ in categorizing DOAC doses, on-label DOAC use by any formula is noninferior to warfarin for thromboembolism and reduces major bleeding.
On-label DOAC use was noninferior to warfarin for thromboembolism regardless of renal formula; leaves open optimal dosing strategies in atrial fibrillation.
The Cockcroft-Gault (CG) formula is recommended to guide clinicians in the choice of the appropriate dosage for direct oral anticoagulants (DOACs). However, the performance of the CG formula varies depending on the patient's age, weight, and degree of renal function. We aimed to compare the validity of the CG formula with that of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease (MDRD) formulae for dosing DOACs. A total of 6268 consecutive patients on anticoagulants for atrial fibrillation (AF) were retrospectively investigated. Among underweight and elderly patients, the CG formula underestimated renal function compared with the non-CG formulae. However, the concordant rate of drug indications between the CG and the non-CG formulae was approximately 94%. On-label uses under the three formulae were associated with a lower risk of major bleeding (but not thromboembolism) compared to warfarin. Although we found differences in estimating renal function and the proportions of drug indications between the CG and non-CG formulae, the risks of thromboembolism and major bleeding were similar to those with warfarin regardless of which formula was used.
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Lee et al. (2019) conducted a cohort in Atrial Fibrillation (n=6,268). Direct oral anticoagulants (on-label use) vs. Warfarin was evaluated on Thromboembolism (p=<0.001 for noninferiority). On-label use of DOACs resulted in a thromboembolism rate of 1.33%/year compared to 1.35%/year with warfarin, demonstrating noninferiority (p<0.001) regardless of the renal function formula used.
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