International Journal of Cardiology 185 (2015) 209–213
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Rivaroxaban versus warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation: A meta-analysis Kevin Phan a,⁎, Nelson Wang b, Laurent Pison c, Narendra Kumar c, Kerry Hitos d, Stuart P. Thomas a a
Department of Cardiology, Westmead Hospital, Sydney, Australia University of Sydney, Sydney, Australia Department of Cardiology, Maastricht University Hospital, Maastricht, The Netherlands d Department of Surgery, Westmead Hospital, Sydney, Australia b c
a r t i c l e
i n f o
Article history: Received 27 January 2015 Accepted 7 March 2015 Available online 10 March 2015 Keywords: Ablation Dabigatran Warfarin Rivaroxaban Thromboembolism VKA
Atrial fibrillation (AF) is the most common sustained arrhythmia. In symptomatic patient, catheter ablation is increasingly used as the established therapeutic strategy of choice [1–3]. The risk of periprocedural thromboembolic events with this treatment is however substantial, reported as 5% in a recent study [4]. Current guidelines suggest the use of warfarin (VKA) as an anticoagulant to minimize this risk [5]. In addition, new oral anticoagulants (NOACs) such as apixaban, dabigatran and rivaroxaban have been recently developed and shown to have similar efficacy to VKA [6]. However their safety and efficacy for catheter ablation in the treatment of AF patients have not been well established. The current paper attempts to determine the efficacy and safety profile of rivaroxaban (Xarelto, Bayer HealthCare) compared to dabigatran (Pradaxa, Boehringer Ingelheim) and VKA for AF patients undergoing catheter ablation. A systematic search was performed with six electronic databases from their inception to November 2014. “Rivaroxaban”, “dabigatran”, “warfarin”, “VKA”, “catheter ablation”, and “atrial fibrillation” were used as key words or MeSH headings. Inclusion criteria were studies comparing rivaroxaban and VKA, or rivaroxaban and dabigatran in patients undergoing catheter ablation for AF. In contrast to prior metaanalyses, abstracts, case reports, conference presentations and editorials ⁎ Corresponding author at: Department of Cardiology, Westmead Hospital, Hawkesbury Rd., Westmead, Sydney, NSW 2145, Australia. E-mail address: [email protected] (K. Phan).
http://dx.doi.org/10.1016/j.ijcard.2015.03.102 0167-5273/© 2015 Elsevier Ireland Ltd. All rights reserved.
were excluded. When institutions published overlapping patient populations or increased lengths of follow-up, only the most completed reports were included for assessment. Meta-analysis was performed by combining extracted data as pooled incidence of mortality or complications. The relative risk (RR) was used as a summary statistic for dichotomous variables, and weighted mean difference (WMD) for continuous variables. Random effects model was used. χ2 tests were used to study heterogeneity between trials. A total of 8 studies were identified [6,10–16], including 5 prospective studies and 3 retrospective studies (Table 1). Two of the studies were randomized. There were no significant differences between rivaroxaban and VKA cohorts in terms of baseline characteristics, including age, proportion of males, paroxysmal AF, persistent AF, prior stroke/TIA, CHADSVASc and CHADS2 scores. Compared to the dabigatran cohort, the rivaroxaban group was more hypertensive (52.8% vs 50.9%; P = 0.04) and had higher CHADS2 scores (P = 0.0001). Other study characteristics are summarized in Table 1. There were no differences found between the rivaroxaban group and the VKA group in terms of strokes (0.3% vs 0.5%, P = 0.44), TIA (0.2% vs 0.2%; P = 0.80), and thromboembolism (0.4% vs 0.3%, P = 0.50) (Fig. 1). There was also no difference between rivaroxaban and dabigatran groups in terms of strokes (0.2% vs 0.2%, P = 0.88), TIA (0.2% vs 0.1%, P = 0.80) and thromboembolism (0.5% vs 0.2%, P = 0.76) (Fig. 1). No significant heterogeneity (I2 = 0%) was detected for these outcomes. The rates of major bleeding were similar between rivaroxaban and VKA groups (P = 0.72) as well as dabigatran and VKA groups (P = 0.34) (Fig. 2). The minor bleeding rates had a trend towards being lower in the rivaroxaban group compared to VKA (5.0% vs 7.1%, P = 0.07). However no difference was detected in these outcomes when compared with dabigatran (P = 0.59). Other complications were also comparable between rivaroxaban and VKA, including pericardial tamponades (P = 0.57) and groin hematoma (P = 0.33) (Fig. 3). Similar trends were also observed for rivaroxaban compared to dabigatran for pericardial tamponades (P = 0.92). Although not significant, there was a trend towards lower groin hematomas in the dabigatran group (1.2% vs 0.1%; P = 0.09). The results of the present study suggest similar safety and efficacy for rivaroxaban compared with VKA and dabigatran during periprocedural period for catheter ablation. Rivaroxaban is a synthetic direct Factor Xa inhibitor that offers advantages such as rapid onset, yet a shorter duration, requiring only once-daily dosing. Dabigatran a direct thrombin (factor IIa) inhibitor requires twice daily dosing [7]. In contrast, VKA
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K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
Table 1 Study characteristics. n, number of patients; ACT, activated clotting time; R, retrospective; P, prospective; OS, observational study; RCT, randomized controlled trial. First author Year
Study n n (VKA) design (rivaroxaban)
Rivaroxaban dosage
Timing of first held dose of rivaroxaban
Time interval for restarting after procedure
Time first held for VKA
Time restart VKA
Morning after procedure Morning after procedure Morning after procedure 4–6 h after procedure
Uninterrupted
Uninterrupted 270–300
5 days prior
Evening of 225 procedure Uninterrupted N350
Evening of procedure
Uninterrupted
Evening of N300 procedure Uninterrupted 300–400
NR
NR
NR
NR
Time interval for restarting after procedure
Time first held for dabigatran
Time restart dabigatran
Target ACT (s)
36 or 48 h prior 24 h prior
Morning after procedure Morning after procedure 4–6 h after procedure 4 h after procedure Evening of procedure
225
Dillier
2014 R, OS
272
272
15, 20 mg
36 h prior
Winkle
2014 R, OS
187
113
15, 20 mg
36 h prior
Stepenyan
2014 R, OS
98
114
NR
24 h prior
Providencia 2014 P, OS
188
192
15, 20 mg
24–48 h prior
Lakkireddy
2014 P, OS
321
321
15, 20 mg
Piccini
2013 P, RCT
160
161
15, 20 mg
Evening prior procedure NR
First author Year
Study n n Rivaroxaban/dabigatran Timing of first held design (rivaroxaban) (dabigatran) dosage dose of rivaroxaban
Winkle
2014 R, OS
187
426
Stepenyan
2014 R, OS
98
89
Providencia 2014 P, OS
188
176
Sairaku
2013 P, RCT
30
30
Eitel
2013 P, OS
16
243
Uninterrupted 5 days prior
15, 20 mg/75, 150 mg
36 h prior
NR
2 days prior
15, 20 mg/110, 150 mg
24–48 h prior
Morning after procedure Morning after procedure 4–6 h after procedure
15 mg/110 mg
24 h prior
4 h after procedure
48 h prior
20 mg/110, 150 mg
Day prior
Evening of procedure
Evening prior
requires extensive monitoring to maintain an international normalized ratio (INR) between 2–3 [8]. In addition stroke, transient ischaemic attacks and thromboembolism rates were notably low in the present study. However questions regarding the optimal dosing schedule leading up to and post-ablation cannot be answered by this meta-analysis and will be affected by a host of factors including renal clearance and dosage used. It is important to note that there are no approved reversal agents for the NOACs which may limit their use [9]. The study had several notable limitations. There was a small sample size of patients available for analysis, limiting the statistical power.
24–36 h prior
Target ACT (s)
N350 N300 300–400 300–350
Heterogeneity existed across the studies due to variations in dosage and protocols used to withhold and readminister the anticoagulant. This was an observational study, making it susceptible to selection bias. There was also a lack of patient-level data and thus subgroup analysis could not be performed. This systematic review demonstrated a lack of clinical robust evidence for the safety and efficacy of rivaroxaban. Current evidence suggests similar safety and efficacy profile to VKA and dabigatran. However the paucity of studies available means that future randomized studies are required to definitively draw conclusions.
Fig. 1. Forest plots for (A) strokes; (B) TIA; (C) thromboembolism.
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
211
Fig. 1 (continued).
Conflict of interests None declared. Acknowledgments None declared. Funding None declared. References [1] V. Fuster, L.E. Ryden, D.S. Cannom, et al., 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation, Circulation 123 (2011) E269–E367. [2] D.M. Lloyd-Jones, T.J. Wang, E.P. Leip, et al., Lifetime risk for development of atrial fibrillation: the Framingham Heart Study, Circulation 110 (2004) 1042–1046. [3] K. Kearney, R. Stephenson, K. Phan, W.Y. Chan, M.Y. Huang, T.D. Yan, A systematic review of surgical ablation versus catheter ablation for trial fibrillation, Ann. Cardiothorac. Surg. 3 (2014) 15–29.
[4] Luigi Di Biase, David Burkhardt, Pasquale Santangeli, Prasant Mohanty, Javier Sanchez, Rodney Horton, G. Joseph Gallinghouse, et al., Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial, Circulation 129 (2014) 2638–2644. [5] H. Calkins, K.H. Kuck, R. Cappato, et al., 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society, Heart Rhythm. 9 (2012) 632–696 (e21). [6] Charlotte Eitel, Julia Koch, Philipp Sommer, Silke John, Simon Kircher, Andreas Bollmann, Arash Arya, Christopher Piorkowski, Gerhard Hindricks, Novel oral anticoagulants in a real-world cohort of patients undergoing catheter ablation of atrial fibrillation, Europace 15 (2013) 1587–1593.
212
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
Fig. 2. (A) Major bleeding; (B) minor bleeding.
[7] Amanda R. Harrington, Edward P. Armstrong, Paul E. Nolan, Daniel C. Malone, Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation, Stroke 44 (6) (2013) 1676–1681. [8] P. Santangeli, L. Di Biase, R. Horton, J.D. Burkhardt, J. Sanchez, A. Al-Ahmad, R. Hongo, S. Beheiry, R. Bai, P. Mohanty, W.R. Lewis, A. Natale, Ablation of atrial fibrillation under therapeutic warfarin reduces periprocedural complications: evidence from a meta-analysis, Circ. Arrhythm. Electrophysiol. 5 (2012) 302–311. [9] Raphael Marlu, et al., Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban, Thromb. Haemost. 108 (2) (2012) 217–224. [10] Jonathan P. Piccini, Susanna R. Stevens, Yuliya Lokhnygina, Manesh R. Patel, Jonathan L. Halperin, Daniel E. Singer, Graeme J. Hankey, et al., Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial, J. Am. Coll. Cardiol. 61 (19) (2013) 1998–2006. [11] Roger Dillier, Sonia Ammar, Gabriele Hessling, Bernhard Kaess, Herribert Pavaci, Alessandra Buiatti, Verena Semmler, et al., Safety of continuous periprocedural rivaroxaban for patients undergoing left atrial catheter ablation procedures, Circ. Arrhythm. Electrophysiol. 7 (2014) 576–582. [12] Rui Providência, Eloi Marijon, Jean-Paul Albenque, Stéphane Combes, Nicolas Combes, François Jourda, Hassiba Hireche, João Morais, Serge Boveda, Rivaroxaban
[13]
[14]
[15]
[16]
and dabigatran in patients undergoing catheter ablation of atrial fibrillation, Europace 16 (2014) 1137–1144. Gevorg Stepanyan, Nitish Badhwar, Randall J. Lee, Gregory M. Marcus, Byron K. Lee, Zian H. Tseng, Vasanth Vedantham, Jeffrey Olgin, Melvin Scheinman, Edward P. Gerstenfeld, Safety of new oral anticoagulants for patients undergoing atrial fibrillation ablation, J. Interv. Card. Electrophysiol. (2014) 1–6. Akinori Sairaku, Yukihiko Yoshida, Monami Ando, Haruo Hirayama, Yukiko Nakano, Yasuki Kihara, A head-to-head comparison of periprocedural coagulability under anticoagulation with rivaroxaban versus dabigatran in patients undergoing ablation of atrial fibrillation, Clin. Drug Investig. 33 (11) (2013) 847–853. Dhanunjaya Lakkireddy, Yeruva Madhu Reddy, Luigi Di Biase, Ajay Vallakati, Moussa C. Mansour, Pasquale Santangeli, Sandeep Gangireddy, et al., Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry, J. Am. Coll. Cardiol. 63 (10) (2014) 982–988. Roger A. Winkle, R. Hardwin Mead, Gregory Engel, Melissa H. Kong, Rob A. Patrawala, Peri-procedural interrupted oral anticoagulation for atrial fibrillation ablation: comparison of aspirin, warfarin, dabigatran, and rivaroxaban, Europace 16 (10) (2014) 1443–1449.
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
Fig. 3. (A) Pericardial tamponade; (B) groin hematoma.
213
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Rivaroxaban versus warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation: A meta-analysis Kevin Phan a,⁎, Nelson Wang b, Laurent Pison c, Narendra Kumar c, Kerry Hitos d, Stuart P. Thomas a a
Department of Cardiology, Westmead Hospital, Sydney, Australia University of Sydney, Sydney, Australia Department of Cardiology, Maastricht University Hospital, Maastricht, The Netherlands d Department of Surgery, Westmead Hospital, Sydney, Australia b c
a r t i c l e
i n f o
Article history: Received 27 January 2015 Accepted 7 March 2015 Available online 10 March 2015 Keywords: Ablation Dabigatran Warfarin Rivaroxaban Thromboembolism VKA
Atrial fibrillation (AF) is the most common sustained arrhythmia. In symptomatic patient, catheter ablation is increasingly used as the established therapeutic strategy of choice [1–3]. The risk of periprocedural thromboembolic events with this treatment is however substantial, reported as 5% in a recent study [4]. Current guidelines suggest the use of warfarin (VKA) as an anticoagulant to minimize this risk [5]. In addition, new oral anticoagulants (NOACs) such as apixaban, dabigatran and rivaroxaban have been recently developed and shown to have similar efficacy to VKA [6]. However their safety and efficacy for catheter ablation in the treatment of AF patients have not been well established. The current paper attempts to determine the efficacy and safety profile of rivaroxaban (Xarelto, Bayer HealthCare) compared to dabigatran (Pradaxa, Boehringer Ingelheim) and VKA for AF patients undergoing catheter ablation. A systematic search was performed with six electronic databases from their inception to November 2014. “Rivaroxaban”, “dabigatran”, “warfarin”, “VKA”, “catheter ablation”, and “atrial fibrillation” were used as key words or MeSH headings. Inclusion criteria were studies comparing rivaroxaban and VKA, or rivaroxaban and dabigatran in patients undergoing catheter ablation for AF. In contrast to prior metaanalyses, abstracts, case reports, conference presentations and editorials ⁎ Corresponding author at: Department of Cardiology, Westmead Hospital, Hawkesbury Rd., Westmead, Sydney, NSW 2145, Australia. E-mail address: [email protected] (K. Phan).
http://dx.doi.org/10.1016/j.ijcard.2015.03.102 0167-5273/© 2015 Elsevier Ireland Ltd. All rights reserved.
were excluded. When institutions published overlapping patient populations or increased lengths of follow-up, only the most completed reports were included for assessment. Meta-analysis was performed by combining extracted data as pooled incidence of mortality or complications. The relative risk (RR) was used as a summary statistic for dichotomous variables, and weighted mean difference (WMD) for continuous variables. Random effects model was used. χ2 tests were used to study heterogeneity between trials. A total of 8 studies were identified [6,10–16], including 5 prospective studies and 3 retrospective studies (Table 1). Two of the studies were randomized. There were no significant differences between rivaroxaban and VKA cohorts in terms of baseline characteristics, including age, proportion of males, paroxysmal AF, persistent AF, prior stroke/TIA, CHADSVASc and CHADS2 scores. Compared to the dabigatran cohort, the rivaroxaban group was more hypertensive (52.8% vs 50.9%; P = 0.04) and had higher CHADS2 scores (P = 0.0001). Other study characteristics are summarized in Table 1. There were no differences found between the rivaroxaban group and the VKA group in terms of strokes (0.3% vs 0.5%, P = 0.44), TIA (0.2% vs 0.2%; P = 0.80), and thromboembolism (0.4% vs 0.3%, P = 0.50) (Fig. 1). There was also no difference between rivaroxaban and dabigatran groups in terms of strokes (0.2% vs 0.2%, P = 0.88), TIA (0.2% vs 0.1%, P = 0.80) and thromboembolism (0.5% vs 0.2%, P = 0.76) (Fig. 1). No significant heterogeneity (I2 = 0%) was detected for these outcomes. The rates of major bleeding were similar between rivaroxaban and VKA groups (P = 0.72) as well as dabigatran and VKA groups (P = 0.34) (Fig. 2). The minor bleeding rates had a trend towards being lower in the rivaroxaban group compared to VKA (5.0% vs 7.1%, P = 0.07). However no difference was detected in these outcomes when compared with dabigatran (P = 0.59). Other complications were also comparable between rivaroxaban and VKA, including pericardial tamponades (P = 0.57) and groin hematoma (P = 0.33) (Fig. 3). Similar trends were also observed for rivaroxaban compared to dabigatran for pericardial tamponades (P = 0.92). Although not significant, there was a trend towards lower groin hematomas in the dabigatran group (1.2% vs 0.1%; P = 0.09). The results of the present study suggest similar safety and efficacy for rivaroxaban compared with VKA and dabigatran during periprocedural period for catheter ablation. Rivaroxaban is a synthetic direct Factor Xa inhibitor that offers advantages such as rapid onset, yet a shorter duration, requiring only once-daily dosing. Dabigatran a direct thrombin (factor IIa) inhibitor requires twice daily dosing [7]. In contrast, VKA
210
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
Table 1 Study characteristics. n, number of patients; ACT, activated clotting time; R, retrospective; P, prospective; OS, observational study; RCT, randomized controlled trial. First author Year
Study n n (VKA) design (rivaroxaban)
Rivaroxaban dosage
Timing of first held dose of rivaroxaban
Time interval for restarting after procedure
Time first held for VKA
Time restart VKA
Morning after procedure Morning after procedure Morning after procedure 4–6 h after procedure
Uninterrupted
Uninterrupted 270–300
5 days prior
Evening of 225 procedure Uninterrupted N350
Evening of procedure
Uninterrupted
Evening of N300 procedure Uninterrupted 300–400
NR
NR
NR
NR
Time interval for restarting after procedure
Time first held for dabigatran
Time restart dabigatran
Target ACT (s)
36 or 48 h prior 24 h prior
Morning after procedure Morning after procedure 4–6 h after procedure 4 h after procedure Evening of procedure
225
Dillier
2014 R, OS
272
272
15, 20 mg
36 h prior
Winkle
2014 R, OS
187
113
15, 20 mg
36 h prior
Stepenyan
2014 R, OS
98
114
NR
24 h prior
Providencia 2014 P, OS
188
192
15, 20 mg
24–48 h prior
Lakkireddy
2014 P, OS
321
321
15, 20 mg
Piccini
2013 P, RCT
160
161
15, 20 mg
Evening prior procedure NR
First author Year
Study n n Rivaroxaban/dabigatran Timing of first held design (rivaroxaban) (dabigatran) dosage dose of rivaroxaban
Winkle
2014 R, OS
187
426
Stepenyan
2014 R, OS
98
89
Providencia 2014 P, OS
188
176
Sairaku
2013 P, RCT
30
30
Eitel
2013 P, OS
16
243
Uninterrupted 5 days prior
15, 20 mg/75, 150 mg
36 h prior
NR
2 days prior
15, 20 mg/110, 150 mg
24–48 h prior
Morning after procedure Morning after procedure 4–6 h after procedure
15 mg/110 mg
24 h prior
4 h after procedure
48 h prior
20 mg/110, 150 mg
Day prior
Evening of procedure
Evening prior
requires extensive monitoring to maintain an international normalized ratio (INR) between 2–3 [8]. In addition stroke, transient ischaemic attacks and thromboembolism rates were notably low in the present study. However questions regarding the optimal dosing schedule leading up to and post-ablation cannot be answered by this meta-analysis and will be affected by a host of factors including renal clearance and dosage used. It is important to note that there are no approved reversal agents for the NOACs which may limit their use [9]. The study had several notable limitations. There was a small sample size of patients available for analysis, limiting the statistical power.
24–36 h prior
Target ACT (s)
N350 N300 300–400 300–350
Heterogeneity existed across the studies due to variations in dosage and protocols used to withhold and readminister the anticoagulant. This was an observational study, making it susceptible to selection bias. There was also a lack of patient-level data and thus subgroup analysis could not be performed. This systematic review demonstrated a lack of clinical robust evidence for the safety and efficacy of rivaroxaban. Current evidence suggests similar safety and efficacy profile to VKA and dabigatran. However the paucity of studies available means that future randomized studies are required to definitively draw conclusions.
Fig. 1. Forest plots for (A) strokes; (B) TIA; (C) thromboembolism.
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
211
Fig. 1 (continued).
Conflict of interests None declared. Acknowledgments None declared. Funding None declared. References [1] V. Fuster, L.E. Ryden, D.S. Cannom, et al., 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation, Circulation 123 (2011) E269–E367. [2] D.M. Lloyd-Jones, T.J. Wang, E.P. Leip, et al., Lifetime risk for development of atrial fibrillation: the Framingham Heart Study, Circulation 110 (2004) 1042–1046. [3] K. Kearney, R. Stephenson, K. Phan, W.Y. Chan, M.Y. Huang, T.D. Yan, A systematic review of surgical ablation versus catheter ablation for trial fibrillation, Ann. Cardiothorac. Surg. 3 (2014) 15–29.
[4] Luigi Di Biase, David Burkhardt, Pasquale Santangeli, Prasant Mohanty, Javier Sanchez, Rodney Horton, G. Joseph Gallinghouse, et al., Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial, Circulation 129 (2014) 2638–2644. [5] H. Calkins, K.H. Kuck, R. Cappato, et al., 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society, Heart Rhythm. 9 (2012) 632–696 (e21). [6] Charlotte Eitel, Julia Koch, Philipp Sommer, Silke John, Simon Kircher, Andreas Bollmann, Arash Arya, Christopher Piorkowski, Gerhard Hindricks, Novel oral anticoagulants in a real-world cohort of patients undergoing catheter ablation of atrial fibrillation, Europace 15 (2013) 1587–1593.
212
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
Fig. 2. (A) Major bleeding; (B) minor bleeding.
[7] Amanda R. Harrington, Edward P. Armstrong, Paul E. Nolan, Daniel C. Malone, Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation, Stroke 44 (6) (2013) 1676–1681. [8] P. Santangeli, L. Di Biase, R. Horton, J.D. Burkhardt, J. Sanchez, A. Al-Ahmad, R. Hongo, S. Beheiry, R. Bai, P. Mohanty, W.R. Lewis, A. Natale, Ablation of atrial fibrillation under therapeutic warfarin reduces periprocedural complications: evidence from a meta-analysis, Circ. Arrhythm. Electrophysiol. 5 (2012) 302–311. [9] Raphael Marlu, et al., Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban, Thromb. Haemost. 108 (2) (2012) 217–224. [10] Jonathan P. Piccini, Susanna R. Stevens, Yuliya Lokhnygina, Manesh R. Patel, Jonathan L. Halperin, Daniel E. Singer, Graeme J. Hankey, et al., Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial, J. Am. Coll. Cardiol. 61 (19) (2013) 1998–2006. [11] Roger Dillier, Sonia Ammar, Gabriele Hessling, Bernhard Kaess, Herribert Pavaci, Alessandra Buiatti, Verena Semmler, et al., Safety of continuous periprocedural rivaroxaban for patients undergoing left atrial catheter ablation procedures, Circ. Arrhythm. Electrophysiol. 7 (2014) 576–582. [12] Rui Providência, Eloi Marijon, Jean-Paul Albenque, Stéphane Combes, Nicolas Combes, François Jourda, Hassiba Hireche, João Morais, Serge Boveda, Rivaroxaban
[13]
[14]
[15]
[16]
and dabigatran in patients undergoing catheter ablation of atrial fibrillation, Europace 16 (2014) 1137–1144. Gevorg Stepanyan, Nitish Badhwar, Randall J. Lee, Gregory M. Marcus, Byron K. Lee, Zian H. Tseng, Vasanth Vedantham, Jeffrey Olgin, Melvin Scheinman, Edward P. Gerstenfeld, Safety of new oral anticoagulants for patients undergoing atrial fibrillation ablation, J. Interv. Card. Electrophysiol. (2014) 1–6. Akinori Sairaku, Yukihiko Yoshida, Monami Ando, Haruo Hirayama, Yukiko Nakano, Yasuki Kihara, A head-to-head comparison of periprocedural coagulability under anticoagulation with rivaroxaban versus dabigatran in patients undergoing ablation of atrial fibrillation, Clin. Drug Investig. 33 (11) (2013) 847–853. Dhanunjaya Lakkireddy, Yeruva Madhu Reddy, Luigi Di Biase, Ajay Vallakati, Moussa C. Mansour, Pasquale Santangeli, Sandeep Gangireddy, et al., Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry, J. Am. Coll. Cardiol. 63 (10) (2014) 982–988. Roger A. Winkle, R. Hardwin Mead, Gregory Engel, Melissa H. Kong, Rob A. Patrawala, Peri-procedural interrupted oral anticoagulation for atrial fibrillation ablation: comparison of aspirin, warfarin, dabigatran, and rivaroxaban, Europace 16 (10) (2014) 1443–1449.
K. Phan et al. / International Journal of Cardiology 185 (2015) 209–213
Fig. 3. (A) Pericardial tamponade; (B) groin hematoma.
213
