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Open Access 03-11-2023 | Atrial Fibrillation | Original Paper

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial

Authors: Jan Wilko Schrickel, Thomas Beiert, Markus Linhart, Julian A. Luetkens, Jennifer Schmitz, Matthias Schmid, Gerhard Hindricks, Thomas Arentz, Christoph Stellbrink, Thomas Deneke, Harilaos Bogossian, Armin Sause, Daniel Steven, Bernd-Dieter Gonska, Boris Rudic, Thorsten Lewalter, Markus Zabel, Tobias Geisler, Burghard Schumacher, Werner Jung, Thomas Kleemann, Armin Luik, Christian Veltmann, Martin Coenen, Georg Nickenig

Published in: Clinical Research in Cardiology

Abstract

Background and objectives

Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI).

Methods

This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE).

Results

Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ.

Conclusion

Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.

Graphical abstract

Available only for authorised users

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Title: Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial
Authors: Jan Wilko Schrickel
Thomas Beiert
Markus Linhart
Julian A. Luetkens
Jennifer Schmitz
Matthias Schmid
Gerhard Hindricks
Thomas Arentz
Christoph Stellbrink
Thomas Deneke
Harilaos Bogossian
Armin Sause
Daniel Steven
Bernd-Dieter Gonska
Boris Rudic
Thorsten Lewalter
Markus Zabel
Tobias Geisler
Burghard Schumacher
Werner Jung
Thomas Kleemann
Armin Luik
Christian Veltmann
Martin Coenen
Georg Nickenig
Publication date: 03-11-2023
Publisher: Springer Berlin Heidelberg
Keywords: Atrial Fibrillation
Stroke
Dabigatran
Published in: Clinical Research in Cardiology
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-023-02319-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial

Abstract

Background and objectives

Methods

Results

Conclusion

Graphical abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background and objectives

Methods

Results

Conclusion

Graphical abstract

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