Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation
Atul Verma, David H. Birnie, Chenyang Jiang, Hein Heidbüchel, Gerhard Hindricks, Paulus Kirchhof, Jeff S. Healey, Yunhe Wang, Nikolaos Dagres, Marc W. Deyell, Prashanthan Sanders, Rajeev K. Pathak, Pieter Koopman, Dieter Nuyens, Paul Novak, Guy Amit, Charles Dussault, Bhavanesh Makanjee, F. Russell Quinn, Umjeet Jolly, Leon Iden, Malte Kuniss, Mukul Sharma, Andrew C.T. Ha, Vidal Essebag, Jean Champagne, Michael D. Hill, Eric E. Smith, George A. Wells
Abstract
BACKGROUND: Whether successful catheter ablation for atrial fibrillation eliminates the need for long-term oral anticoagulant therapy is unknown. METHODS: -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. (Funded by Bayer and others; OCEAN ClinicalTrials.gov number, NCT02168829.).