Effectiveness and Safety of DOACs in Atrial Fibrillation Patients Undergoing Catheter Ablation: Results from the China Atrial Fibrillation (China-AF) Registry

Background Direct oral anticoagulants (DOACs) have increasingly become an alternative to warfarin in atrial fibrillation (AF) patients. Nonetheless, data on the effectiveness and safety of DOACs in periprocedural of catheter ablation (CA) in real-world practice was relatively rare. Methods and Results 3385 AF patients underwent initial CA and never used oral anticoagulant before enrollment between April 2013 and December 2018 were involved from China Atrial Fibrillation (China-AF) Registry. Warfarin, rivaroxaban and dabigatran were used in 1896 (56.0%), 718 (21.2%), and 771 (22.8%) patients, respectively. Propensity score matching was used to balance covariates across study groups. No significant differences were observed in rivaroxaban-warfarin, dabigatran-warfarin and dabigatran-rivaroxaban cohort for thromboembolic (TE) and major bleeding (MB) incidence. Similar results were also revealed in low-dose rivaroxaban (RLD)-warfarin, low-dose dabigatran (DLD)-warfarin and DLD-RLD cohort. However, the risk of non-MB was higher not only on standard-dose of rivaroxaban but also on RLD when compared with warfarin and with DLD, respectively. Conclusions In this study, the incidence of TE and MB were both comparable in standard- or low-dose DOACs versus warfarin and between the two DOACs, whereas the risk of non-MB was higher in rivaroxaban than in warfarin and in RLD than in DLD.

[1]  R. Bai,et al.  Effectiveness and safety of atrial fibrillation ablation in females , 2020, Pacing and clinical electrophysiology : PACE.

[2]  G. Lip,et al.  Effectiveness and Safety of Four Direct Oral Anticoagulants in Asian Patients With Nonvalvular Atrial Fibrillation. , 2019, Chest.

[3]  E. Antman,et al.  Clinical outcomes, edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial. , 2019, European heart journal.

[4]  Hugh Calkins,et al.  2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. , 2019, Heart rhythm.

[5]  Yao Lu,et al.  A meta-analysis of randomized controlled trials of uninterrupted periprocedural anticoagulation strategy in patients undergoing atrial fibrillation catheter ablation. , 2018, International journal of cardiology.

[6]  M. Harada,et al.  Left Atrial Appendage Thrombus Prior to Atrial Fibrillation Ablation in the Era of Direct Oral Anticoagulants. , 2018, Circulation journal : official journal of the Japanese Circulation Society.

[7]  S. Markowitz,et al.  Left atrial thrombus and dense spontaneous echocardiographic contrast in patients on continuous direct oral anticoagulant therapy undergoing catheter ablation of atrial fibrillation: Comparison of dabigatran, rivaroxaban, and apixaban. , 2018, Heart rhythm.

[8]  P. Kirchhof,et al.  Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation , 2018, European heart journal.

[9]  M. Chung,et al.  2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation , 2017, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[10]  Duk‐Woo Park,et al.  Outcomes After Use of Standard- and Low-Dose Non–Vitamin K Oral Anticoagulants in Asian Patients With Atrial Fibrillation , 2018, Stroke.

[11]  S. Kohsaka,et al.  Bleeding risk of apixaban, dabigatran, and low-dose rivaroxaban compared with warfarin in Japanese patients with non-valvular atrial fibrillation: a propensity matched analysis of administrative claims data , 2017, Current medical research and opinion.

[12]  B. Løfgren,et al.  Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. , 2017, The New England journal of medicine.

[13]  M. Chung,et al.  2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation , 2017, Heart rhythm.

[14]  M. Shoda,et al.  Report of periprocedural oral anticoagulants in catheter ablation for atrial fibrillation: The Japanese Catheter Ablation Registry of Atrial Fibrillation (J-CARAF) , 2016, Journal of arrhythmia.

[15]  A. Camm,et al.  Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation: Executive summary , 2016, European heart journal.

[16]  S. Samii,et al.  Meta-analysis of efficacy and safety of apixaban and uninterrupted apixaban therapy compared to vitamin K antagonists in patients undergoing catheter ablation for atrial fibrillation , 2017, Journal of Interventional Cardiac Electrophysiology.

[17]  J. Douketis,et al.  To measure or not to measure direct oral anticoagulants before surgery or invasive procedures: comment , 2016, Journal of thrombosis and haemostasis : JTH.

[18]  K. Hirao,et al.  Efficacy and Safety of Rivaroxaban and Warfarin in the Perioperative Period of Catheter Ablation for Atrial Fibrillation　- Outcome Analysis From a Prospective Multicenter Registry Study in Japan. , 2016, Circulation journal : official journal of the Japanese Circulation Society.

[19]  A. Tripodi,et al.  To measure or not to measure direct oral anticoagulants before surgery or invasive procedures , 2016, Journal of thrombosis and haemostasis : JTH.

[20]  Qi Hua,et al.  Rationale and design of the Chinese Atrial Fibrillation Registry Study , 2016, BMC Cardiovascular Disorders.

[21]  S. Hohnloser,et al.  Efficacy and safety of rivaroxaban compared with vitamin K antagonists for peri-procedural anticoagulation in catheter ablation of atrial fibrillation: a systematic review and meta-analysis , 2016, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[22]  S. Hohnloser,et al.  Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation , 2015, European heart journal.

[23]  É. Marijon,et al.  Comparison between radiofrequency with contact force-sensing and second-generation cryoballoon for paroxysmal atrial fibrillation catheter ablation: a multicentre European evaluation. , 2015, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[24]  D. Meier,et al.  Methods for constructing and assessing propensity scores. , 2014, Health services research.

[25]  M. Ezekowitz,et al.  Response to letter regarding article, "Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation". , 2014, Stroke.

[26]  K. Dabhadkar,et al.  In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010: Analysis of 93 801 Procedures , 2013, Circulation.

[27]  É. Marijon,et al.  Safety and efficacy of dabigatran versus warfarin in patients undergoing catheter ablation of atrial fibrillation: a systematic review and meta-analysis , 2013, Heart.

[28]  S. Yusuf,et al.  Dabigatran Versus Warfarin: Effects on Ischemic and Hemorrhagic Strokes and Bleeding in Asians and Non-Asians With Atrial Fibrillation , 2013, Stroke.

[29]  Yutao Guo,et al.  Performance of the HEMORR(2)HAGES, ATRIA, and HAS-BLED bleeding risk-prediction scores in patients with atrial fibrillation undergoing anticoagulation: the AMADEUS (evaluating the use of SR34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation) study. , 2012, Journal of the American College of Cardiology.

[30]  Marco Valgimigli,et al.  Standardized Bleeding Definitions for Cardiovascular Clinical Trials: A Consensus Report From the Bleeding Academic Research Consortium , 2011, Circulation.

[31]  P. Austin.  An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies , 2011, Multivariate behavioral research.

[32]  Gregory Y H Lip,et al.  Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. , 2010, Chest.

[33]  Elia Biganzoli,et al.  Updated Worldwide Survey on the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation , 2005, Circulation. Arrhythmia and electrophysiology.

[34]  Wansu Chen,et al.  Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. , 2007, Journal of the American College of Cardiology.

[35]  Song-min Huang,et al.  Modified glomerular filtration rate estimating equation for Chinese patients with chronic kidney disease. , 2006, Journal of the American Society of Nephrology : JASN.

[36]  S. Schulman,et al.  Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non‐surgical patients , 2005, Journal of thrombosis and haemostasis : JTH.

[37]  Douglas Packer,et al.  Worldwide Survey on the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation , 2005, Circulation.