CA for AF Outcomes, Complications & Anticoagulation
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Catheter ablation of atrial fibrillation is typically performed with uninterrupted anticoagulation with warfarin or interrupted non–vitamin K antagonist oral anticoagulant therapy. Uninterrupted anticoagulation with a non–vitamin K antagonist oral anticoagulant, such as dabigatran, may be safer; however, controlled data are lacking. We investigated the safety of uninterrupted dabigatran versus warfarin in patients undergoing ablation of atrial fibrillation.
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CA for AF Outcomes, Complications & Anticoagulation
- 2. Outcome and complications of CA for atrial fibrillation
- 3. Anticoagulation: before, during, and after ablation
- 4. Study design and methods
- 6. Calkins H et al. N Engl J Med 2017;376:1627-1636
- 9. Results
- 10. Baseline demographic and clinical characteristics (Ablation Set). Calkins H et al. N Engl J Med 2017;376:1627-1636
- 13. Adverse Events during the Treatment Period (Treated Set). Calkins H et al. N Engl J Med 2017;376:1627-1636 A severe adverse event :an event that is incapacitating or causes an inability to work or perform usual activities.
- 14. Kaplan–Meier Plot of Time to First Adjudicated Major Bleeding Event (Ablation Set). Calkins H et al. N Engl J Med 2017;376:1627-1636
- 15. Discussion
- 19. Limitations and notes An open-label trial. Impractical blinding The trial was exploratory Low incidence of thromboembolic events ? TRR among VKA subjects -66%? sponsored by Boehringer Ingelheim Pharmaceuticals.
Editor's Notes
- Pre-procedural: TEE to rule out thrombus. VKAs should continue therapy during ablation (with an INR of 2–3). Anticoagulation with NOACs is an alternative to warfarin. Peri-procedural: IV heparin should be administered ACT should be≈300 sec. Post-procedural: Anticoagulation should be maintained for at least 8w. incidence of thromboembolic events after CA has never been systematically studied the expected stroke risk has been adopted from non-ablation AF cohorts.
- Paroxysmal AF : recurrent AF (≥two episodes) that terminates spontaneously within 7 days. Episodes of AF of ≤48 hours’ duration that are terminated with electrical or pharmacologic cardioversion. Persistent AF : AF ≥7 days. Episodes of AF in which a decision is made to electrically or pharmacologically cardiovert the patient after ≥48 hours of AF. longstanding persistent AF : AF of >12 months of duration. Documented AF on ≥ (e.g. ECG, Holter monitoring, loop recorder, pacemaker)
- Major Bleeding in Non-Surgical Patients[1] “1. Fatal bleeding. 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
- The trial consisted of four sequential periods: screening period of 0 to 2 weeks; a preablation treatment period of 4 to 8 weeks, to achieve the desired stable anticoagulation range in patients receiving warfarin; a postablation treatment period of 8 weeks (starting with the ablation procedure); a follow-up period of 1 week . Treatment start: warfarin group started at INR was less than 3.0 dabigatran at INR was less than 2.0. All the patients were to undergo preablation TEE to rule out left atrial thrombi. Adherence : Dabigatran adherence was calculated on the basis of the number of capsules taken; The mean adherence with dabigatran was 97.6%, nonadherence was recorded when adherence was not between 80% and 120% [ overdose] of the expected dose. 86.1% received trial medications for at least 8w 98% for at least 6w Warfarin adherence according to ,mean adherence was 66% of the time overall. 84.3% for recived trial medication for at least 8w 98% for at least 6w.
- In the warfarin group: the mean INR at the time of the ablation was similar in patients with and without major bleeding (2.4 and 2.3, respectively). In the dabigatran group: The 41% received the final dose within 4 hr prior to CA – 2 bleeding events 37% received the final dose 4-8 hr prior to CA with 3 bleeding events. The most significant difference in regard to bleeding events was within 1w post CA [ 4 Vs 17]
- Interrupted Vs continuous Noac’s : similar safety and effectiveness: Small samples Small numbers of events Non-randomized Retrospective study designs
- Impractical blinding due to dosing schedule of dabigatran, need for blood testing, and adjustments in the dose of warfarin. The trial was exploratory because the sample required to provide sufficient power to establish formal non-inferiority with an acceptable upper limit of the 95% confidence interval (e.g., 1.5) would have made the trial unfeasible (>2000 patients per group). time within the therapeutic range (TTR)