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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation
Atul Verma1, David H Birnie2, Chenyang Jiang3
1McGill University Health Centre, McGill University, Montreal.
Insights
Rivaroxaban did not significantly reduce stroke risk compared to aspirin in patients with atrial fibrillation after successful catheter ablation. Both treatments showed similar effectiveness in preventing major adverse events.
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- The necessity of long-term oral anticoagulant therapy after successful atrial fibrillation catheter ablation remains uncertain.
- Patients with atrial fibrillation and stroke risk factors require effective preventative strategies.
Purpose of the Study:
- To compare the efficacy and safety of rivaroxaban versus aspirin in preventing stroke and embolism in patients post-atrial fibrillation ablation.
- To evaluate the incidence of new covert embolic strokes using MRI.
Main Methods:
- An international, randomized, blinded-outcome-assessment trial involving 1284 patients with prior successful atrial fibrillation ablation and stroke risk.
- Patients received either rivaroxaban (15 mg) or aspirin (70-120 mg) for 3 years.
- Primary outcome: composite of stroke, systemic embolism, or new covert embolic stroke detected by MRI.
Main Results:
- No significant difference in the primary outcome between rivaroxaban (0.31 events/100 patient-years) and aspirin (0.66 events/100 patient-years) groups (RR 0.56; 95% CI, 0.19 to 1.65).
- Incidence of new cerebral infarcts (<15 mm) was similar: 3.9% with rivaroxaban vs. 4.4% with aspirin.
- Fatal or major bleeding occurred in 1.6% with rivaroxaban versus 0.6% with aspirin.
Conclusions:
- Rivaroxaban did not demonstrate a statistically significant reduction in stroke, systemic embolism, or new covert embolic stroke compared to aspirin in patients successfully treated for atrial fibrillation.
- The study suggests that aspirin may be a viable alternative to rivaroxaban in this patient population, warranting further investigation.
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. (Funded by Bayer and others; OCEAN ClinicalTrials.gov number, NCT02168829.).
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