TY  - JOUR
A1  - Hohnloser, Stefan H.
A1  - Camm, Alan John
A1  - Cappato, Riccardo
A1  - Diener, Hans-Christoph
A1  - Heidbuchel, Hein
A1  - Mont, Lluís
A1  - Morillo, Carlos A
A1  - Lanz, Hans-Joachim
A1  - Rauer, Heiko
A1  - Reimitz, Paul-Egbert
A1  - Smolnik, Rüdiger
A1  - Kautzner, Josef
T1  - Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial
T2  - Europace
N2  - Aims: This post hoc analysis of ELIMINATE-AF evaluated requirements of unfractionated heparin (UFH) and procedure-related bleeding in atrial fibrillation (AF) patients undergoing ablation with uninterrupted edoxaban or vitamin K antagonist (VKA) therapy.
Methods and results: Patients were randomized 2:1 to once-daily edoxaban 60 mg (or dose-reduced 30 mg) or dose-adjusted VKA (target international normalized ratio: 2.0–3.0). Uninterrupted anticoagulation was mandated for 21–28 days’ pre-ablation and 90 days’ post-ablation. During ablation, UFH administration targeted an activated clotting time (ACT) of 300–400 s. Periprocedural bleeding was differentiated between procedure-related (bleeding at puncture side, cardiac tamponade) and unrelated events. Of 614 randomized patients, 553 received study drug and underwent catheter ablation (edoxaban n = 375; VKA n = 178). The median (Q1–Q3) time from last dose to ablation procedure was 14.8 (13.3–16.5) vs. 16.5 (14.8–19.5) h (edoxaban vs. VKA group, respectively). Mean ACT (SD) ≥300 s was observed in 52% edoxaban- vs. 76% VKA-treated patients, despite a higher mean (SD) UFH dose in the edoxaban vs. VKA group [14 261 (6397) IU vs. 11 473 (4300) IU; exploratory P-value < 0.0001]. In the edoxaban group, 13 patients (3.5%) had procedure-related bleeds of whom 9 had received an UFH dose above the median (13 000 IU). In the VKA arm, 7 patients (3.9%) had procedure-related bleeds of whom 3 had received an UFH dose above the median (10 225 IU).
Conclusion: The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.
KW  - Edoxaban
KW  - Non-vitamin K antagonist oral anticoagulants
KW  - Anticoagulant
KW  - Atrial fibrillation
KW  - Ablation
KW  - Periprocedural anticoagulation
KW  - hemorrhage
KW  - vitamin k antagonists
KW  - activated clotting time measurement
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63319
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-633192
SN  - 1532-2092
N1  - This study was supported by Daiichi Sankyo Europe GmbH, Munich, Germany.
N1  - Data availability
De-identified individual participant data and applicable supporting clinical study documents are available on request, depending on circumstances, at https://vivli.org. In cases in which clinical study data and supporting documents are provided pursuant to the sponsor’s policies and procedures, the sponsor will continue to protect the privacy of the clinical study participants. Details on data sharing criteria and the procedure for requesting access can be found at https://vivli.org/ourmember/daiichi-sankyo/.
VL  - 23
IS  - 1
SP  - 65
EP  - 72
PB  - Oxford Univ. Press
CY  - Oxford
ER  -