Author:
Schrickel Jan Wilko,Beiert Thomas,Linhart Markus,Luetkens Julian A.,Schmitz Jennifer,Schmid Matthias,Hindricks Gerhard,Arentz Thomas,Stellbrink Christoph,Deneke Thomas,Bogossian Harilaos,Sause Armin,Steven Daniel,Gonska Bernd-Dieter,Rudic Boris,Lewalter Thorsten,Zabel Markus,Geisler Tobias,Schumacher Burghard,Jung Werner,Kleemann Thomas,Luik Armin,Veltmann Christian,Coenen Martin,Nickenig Georg
Abstract
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
Funder
Boehringer Ingelheim
Universitätsklinikum Bonn
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine,General Medicine
Cited by
1 articles.
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