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Corresponding author. Department of Cardiovascular Diseases - AUSL Romagna, Division of Cardiology, Ospedale S. Maria delle Croci, Viale Randi 5, 48121 Ravenna, Italy
The four currently available non-vitamin K-antagonist oral anticoagulants (NOAC) include
dabigatran, apixaban, edoxaban, and rivaroxaban. Because however of the different
design of the randomized clinical trials in which they were compared with warfarin
for the prevention of stroke and/or systemic embolism in patients with non-valvular
atrial fibrillation (NVAF), NOAC should more properly be considered to be five. In
the ARISTOTLE [
] trials with the factor-Xa inhibitors (FXa) apixaban, edoxaban, and rivaroxaban, respectively,
a single drug dose was contemplated at baseline, namely, 5 mg twice daily for apixaban,
60 mg once daily for edoxaban, and 20 mg once daily for rivaroxaban. In specific subpopulations
with peculiar clinical and/or laboratory characteristics, including two out of three
criteria among age ≥80 years, creatinine ≥1.5 ml/min, and body weight ≤60 kg for apixaban,
at least one of creatinine clearance (CrCl) 30-50 ml/min, body weight ≤60 kg and concomitant
use of potent glycoprotein-P inhibitors for edoxaban, and CrCl 30-50 ml/min for rivaroxaban
[
], all of them ultimately leading to an increased exposure to (and therefore effect
of) the drug, dose reduction to 2.5 mg twice daily for apixaban, 30 mg once daily
for edoxaban, and 15 mg once daily for rivaroxaban, was mandated (Fig. 1). At variance, in the RE-LY [
] trial with the thrombin inhibitor dabigatran two different drug doses, namely, 150 mg
twice daily and 110 mg twice daily, were contemplated at baseline and independently
tested against warfarin in two identical populations (and therefore in a same population)
with no adjustment based on any patient characteristics (Fig. 1). As a consequence, the two arms of the RE-LY [
] trial could be considered as two independent studies.
Fig. 1Design of the randomized clinical trials comparing the non-vitamin K-antagonist oral
anticoagulants dabigatran apixaban, edoxaban, and rivaroxaban vs. warfarin in non-valvular
atrial fibrillation. BID: twice daily; OD: once daily; CrCl: creatinine clearance.
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT‐AF) II Investigators. Frequency and Outcomes of Reduced Dose Non-Vitamin K Antagonist Anticoagulants: Results From ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II).
