• search hit 4 of 4
Back to Result List

Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial

  • 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.

Download full text files

Export metadata

Metadaten
Author:Stefan H. HohnloserORCiD, Alan John CammGND, Riccardo CappatoORCiD, Hans-Christoph DienerORCiDGND, Hein HeidbuchelGND, Lluís MontORCiD, Carlos A MorilloORCiD, Hans-Joachim LanzORCiD, Heiko Rauer, Paul-Egbert ReimitzORCiD, Rüdiger SmolnikGND, Josef Kautzner
URN:urn:nbn:de:hebis:30:3-633192
DOI:https://doi.org/10.1093/europace/euaa199
ISSN:1532-2092
Parent Title (English):Europace
Publisher:Oxford Univ. Press
Place of publication:Oxford
Document Type:Article
Language:English
Date of Publication (online):2020/11/29
Date of first Publication:2020/11/29
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2023/10/24
Tag:Ablation; Anticoagulant; Atrial fibrillation; Edoxaban; Non-vitamin K antagonist oral anticoagulants; Periprocedural anticoagulation; activated clotting time measurement; hemorrhage; vitamin k antagonists
Volume:23
Issue:1
Page Number:8
First Page:65
Last Page:72
Note:
This study was supported by Daiichi Sankyo Europe GmbH, Munich, Germany.
Note:
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/.
Institutes:Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - CC BY-NC - Namensnennung - Nicht kommerziell 4.0 International