Abstract
Despite the proven superiority of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over the Cockcroft–Gault (CG) formula, current guidelines recommend the latter to assess renal function in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). To assess the relationship between the CG and the recommended CKD-EPI formulas, in a cohort of atrial fibrillation (AF) patients treated with NOACs, and the misclassifications introduced by the CG formula for renal function levels, we estimated renal function with three equations: CG, CKD-EPI with body surface adjustment (1.73 mL/m2, CKD-EPI) and without such adjustment (CKD-EPI_noBSA), in all consecutive AF patients discharged from NOACs from the Cardiology Division of a main city hospital between February 1st and May 31st 2018. We compared the different estimates of glomerular filtration rate and potential renal function class misclassifications. We reclassified 37/115 patients (32.1%) when switching from the CG to the CKD-EPI; and 24/115 (20.8%) switching from the CG to the CKD-EPI_noBSA formulas. Class reallocation was distributed across all levels of renal function, but mostly affected the “hyper-normal” function. In estimating consequences of such reallocation, a change in NOAC dosages would have occurred in 10/115 patients (8.7%) when switching from the CG to the CKD-EPI formula and in 10/115 patients when switching from the CG to the CKD-EPI_noBSA formula. Although the CG method has been traditionally used to calculate renal function in all NOAC studies, a renal dysfunction class reallocation occurs in a substantial fraction of hospital-admitted AF patients with the use of better estimates of renal function.
Highlights
In recent years, randomized controlled trials and observational studies have been performed in patients treated with the non-vitamin K antagonist oral anticoagulants (NOACs), currently used for stroke prevention in atrial fibrillation (AF) [1,2] or the prevention and treatment of venous thromboembolism (VTE) [3,4,5]
A formal approval of the protocol from the local Ethics Committee was considered unnecessary because the study did not interfere with the usual clinical routine, the assessment of renal function was part of the routine examinations prescribed to patients, no change in routine dose administration of the NOACs was implemented based on the study results, and data were handed anonymously
The NOACs used in these patients were rivaroxaban in 59 (51.3%), apixaban in 27 (23.5%), edoxaban in 15 (13.0%) and dabigatran in 14 (12.2%)
Summary
In recent years, randomized controlled trials and observational studies have been performed in patients treated with the non-vitamin K antagonist oral anticoagulants (NOACs), currently used for stroke prevention in atrial fibrillation (AF) [1,2] or the prevention and treatment of venous thromboembolism (VTE) [3,4,5]. A similar bidirectional link exists for deep vein thrombosis [12] and pulmonary embolism [13]. The risk for both thromboembolic and severe bleeding events is known to be high in CKD [1], and so, in patients with end-stage kidney disease (ESKD) [14], making risk stratification for the prevention or treatment of thromboembolism challenging in the CKD population [15,16]. The current European Society of Cardiology (ESC) guidelines recommend the use of dabigatran only in patients with an estimated creatinine clearance (eCrCl) ≥ 30 mL/min/1.73 m2, and for rivaroxaban, apixaban and edoxaban in those with a CrCl > 15 mL/min/1.73 m2 [1]. In 2018, the European Heart Rhythm Association (EHRA) issued a warning that in patients with “hyper-normal” renal function (i.e., glomerular filtration rate (GFR) > 95 mL/min/1.73 m2) current dosages of edoxaban, rivaroxaban and apixaban might be insufficient [17]
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