TY - JOUR
T1 - Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation
AU - OCEAN Investigators
AU - Verma, Atul
AU - Birnie, David H.
AU - Jiang, Chenyang
AU - Heidbüchel, Hein
AU - Hindricks, Gerhard
AU - Kirchhof, Paulus
AU - Healey, Jeff S.
AU - Wang, Yunhe
AU - Dagres, Nikolaos
AU - Deyell, Marc W.
AU - Sanders, Prashanthan
AU - Pathak, Rajeev K.
AU - Koopman, Pieter
AU - Nuyens, Dieter
AU - Novak, Paul
AU - Amit, Guy
AU - Dussault, Charles
AU - Makanjee, Bhavanesh
AU - Quinn, F. Russell
AU - Jolly, Umjeet
AU - Iden, Leon
AU - Kuniss, Malte
AU - Sharma, Mukul
AU - Ha, Andrew
AU - Essebag, Vidal
AU - Champagne, Jean
AU - Hill, Michael D.
AU - Smith, Eric E.
AU - Wells, George A.
N1 - Publisher Copyright:
Copyright © 2025 Massachusetts Medical Society.
PY - 2026/1/22
Y1 - 2026/1/22
N2 - BACKGROUND Whether successful catheter ablation for atrial fibrillation eliminates the need for long-term oral anticoagulant therapy is unknown. METHODS We conducted an international, open-label, randomized, blinded-outcome-assessment trial involving 1284 patients who had undergone successful catheter ablation for atrial fibrillation at least 1 year earlier and had a CHA2DS2-VASc score (scores range from 0 to 9, with higher scores indicating a higher risk of stroke) of 1 or more (or ≥2 for women or for patients in whom vascular disease was a risk factor). Patients were randomly assigned to receive either aspirin (at a dose of 70 to 120 mg daily, depending on availability in the local jurisdiction) or rivaroxaban (at a dose of 15 mg) and followed for 3 years. Magnetic resonance imaging (MRI) of the head was performed after enrollment and at 3 years. The primary outcome was a composite of stroke, systemic embolism, or new covert embolic stroke (defined by ≥1 new infarct measuring ≥15 mm on MRI) at 3 years. RESULTS A total of 641 patients were assigned to the rivaroxaban group and 643 to the aspirin group. A primary-outcome event occurred in 5 patients (0.31 events per 100 patient-years) in the rivaroxaban group and in 9 patients (0.66 events per 100 patient-years) in the aspirin group (relative risk, 0.56; 95% confidence interval [CI], 0.19 to 1.65; absolute risk difference at 3 years, −0.6 percentage points; 95% CI, −1.8 to 0.5; P=0.28). New cerebral infarcts measuring less than 15 mm occurred in 22 of 568 patients (3.9%) in the rivaroxaban group and in 26 of 590 patients (4.4%) in the aspirin group (relative risk, 0.89; 95% CI, 0.51 to 1.55). Fatal or major bleeding (the composite primary safety outcome) had occurred in 10 patients (1.6%) with rivaroxaban and in 4 patients (0.6%) with aspirin (hazard ratio, 2.51; 95% CI, 0.79 to 7.95) at 3 years. CONCLUSIONS Among patients who had had successful catheter ablation for atrial fibrillation at least 1 year earlier and had risk factors for stroke, treatment with rivaroxaban did not result in a significantly lower incidence of a composite of stroke, systemic embolism, or new covert embolic stroke than treatment with aspirin.
AB - BACKGROUND Whether successful catheter ablation for atrial fibrillation eliminates the need for long-term oral anticoagulant therapy is unknown. METHODS We conducted an international, open-label, randomized, blinded-outcome-assessment trial involving 1284 patients who had undergone successful catheter ablation for atrial fibrillation at least 1 year earlier and had a CHA2DS2-VASc score (scores range from 0 to 9, with higher scores indicating a higher risk of stroke) of 1 or more (or ≥2 for women or for patients in whom vascular disease was a risk factor). Patients were randomly assigned to receive either aspirin (at a dose of 70 to 120 mg daily, depending on availability in the local jurisdiction) or rivaroxaban (at a dose of 15 mg) and followed for 3 years. Magnetic resonance imaging (MRI) of the head was performed after enrollment and at 3 years. The primary outcome was a composite of stroke, systemic embolism, or new covert embolic stroke (defined by ≥1 new infarct measuring ≥15 mm on MRI) at 3 years. RESULTS A total of 641 patients were assigned to the rivaroxaban group and 643 to the aspirin group. A primary-outcome event occurred in 5 patients (0.31 events per 100 patient-years) in the rivaroxaban group and in 9 patients (0.66 events per 100 patient-years) in the aspirin group (relative risk, 0.56; 95% confidence interval [CI], 0.19 to 1.65; absolute risk difference at 3 years, −0.6 percentage points; 95% CI, −1.8 to 0.5; P=0.28). New cerebral infarcts measuring less than 15 mm occurred in 22 of 568 patients (3.9%) in the rivaroxaban group and in 26 of 590 patients (4.4%) in the aspirin group (relative risk, 0.89; 95% CI, 0.51 to 1.55). Fatal or major bleeding (the composite primary safety outcome) had occurred in 10 patients (1.6%) with rivaroxaban and in 4 patients (0.6%) with aspirin (hazard ratio, 2.51; 95% CI, 0.79 to 7.95) at 3 years. CONCLUSIONS Among patients who had had successful catheter ablation for atrial fibrillation at least 1 year earlier and had risk factors for stroke, treatment with rivaroxaban did not result in a significantly lower incidence of a composite of stroke, systemic embolism, or new covert embolic stroke than treatment with aspirin.
UR - https://www.scopus.com/pages/publications/105028266401
U2 - 10.1056/NEJMoa2509688
DO - 10.1056/NEJMoa2509688
M3 - Artículo
C2 - 41211931
AN - SCOPUS:105028266401
SN - 0028-4793
VL - 394
SP - 323
EP - 332
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 4
ER -