Skip to main content
SpringerLink
Log in

Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: a meta-analysis of observational studies

  • Published:
Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Purpose

Dabigatran is approved for prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (AF). The safety and effectiveness of periprocedural dabigatran in ablation for AF are unknown.

Methods

We performed a meta-analysis of all studies comparing periprocedural dabigatran with warfarin for anticoagulation in AF ablation. Studies of >100 patients with post-procedure follow-up were included. Outcomes were compared by calculating maximum likelihood estimates with confidence intervals. The co-primary endpoints were neurological events and major bleeding.

Results

Ten cohort studies were included, including a total of 1,501 patients receiving dabigatran and 2,356 receiving warfarin. The mean age was 59–64 years and inclusion of women varied (10–33 %). Intra-procedural unfractionated heparin and irrigated ablation catheters were used routinely. Adverse events were low overall; however, the dabigatran group demonstrated a numerical excess of neurological events (10/1,501 [0.7 %] versus 4/2,356 [0.2 %]), but equivalent major bleeding outcomes (24/1,501 [1.6 %] versus 40/2,356 [1.7 %]). In the meta-analysis, there was a nonsignificant trend towards higher rates of the composite primary endpoints (any neurological event or major bleeding) in the dabigatran group. Dabigatran demonstrated a significantly higher rate of neurological events (estimated absolute risk difference 0.0047, 95 % confidence interval 0.0007 to 0.0099).

Conclusions

Compared with warfarin, dabigatran may be associated with a higher frequency of periprocedural neurological events following radiofrequency ablation of AF. Randomized clinical trials are needed to definitively assess the safety and efficacy of novel oral anticoagulant use for periprocedural anticoagulation for ablation of AF.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Fuster, V., Ryden, L. E., Cannom, D. S., Crijns, H. J., Curtis, A. B., Ellenbogen, K. A., et al. (2011). 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation, 123(10), e269-367, doi:10.1161/CIR.0b013e318214876d

    Google Scholar 

  2. Calkins, H., Kuck, K. H., Cappato, R., Brugada, J., Camm, A. J., Chen, S. A., et al. (2012). 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. Journal of Interventional Cardiac Electrophysiology.

  3. Cappato, R., Calkins, H., Chen, S. A., Davies, W., Iesaka, Y., Kalman, J., et al. (2010). Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol, 3(1), 32–38, doi:10.1161/CIRCEP.109.859116

    Google Scholar 

  4. Natale, A., Raviele, A., Arentz, T., Calkins, H., Chen, S. A., Haissaguerre, M., et al. (2007). Venice Chart international consensus document on atrial fibrillation ablation. Journal of Cardiovascular Electrophysiology, 18(5), 560–580.

    Article  PubMed  Google Scholar 

  5. Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., et al. (2009). Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med, 361(12), 1139–1151, doi:10.1056/NEJMoa0905561

    Google Scholar 

  6. Beasley, B. N., Unger, E. F., & Temple, R. (2011). Anticoagulant options—why the FDA approved a higher but not a lower dose of dabigatran. The New England Journal of Medicine, 364(19), 1788–1790. doi:10.1056/NEJMp1103050.

    Article  PubMed  CAS  Google Scholar 

  7. Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gotzsche, P. C., Ioannidis, J. P., et al. (2009). The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Annals of Internal Medicine, 151(4), W65–W94.

    Article  PubMed  Google Scholar 

  8. Moher, D., Liberati, A., Tetzlaff, J., & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Medicine, 6(7), e1000097. doi:10.1371/journal.pmed.1000097.

    Article  PubMed  Google Scholar 

  9. Hasselblad, V., Mosteller, F., Littenberg, B., Chalmers, T. C., Hunink, M. G., Turner, J. A., et al. (1995). A survey of current problems in meta-analysis. Discussion from the Agency for Health Care Policy and Research inter-PORT Work Group on Literature Review/Meta-Analysis. Medical Care, 33(2), 202–220.

    PubMed  CAS  Google Scholar 

  10. Bunch, T. J., Crandall, B. G., Weiss, J. P., Osborn, J. S., May, H. T., & Day, J. D. (2011). Pradaxa can be safely used as monotherapy or as a bridge to therapeutic warfarin after atrial fibrillation ablation. Circulation, 124(21).

  11. Eitel, C., Hindricks, G., & Piorkowski, C. (2012). Dabigatran in patients post atrial fibrillation ablation. Journal of the American College of Cardiology, 59(13), E603.

    Article  Google Scholar 

  12. Winkle, R. A., Mead, R. H., Engel, G., Kong, M. H., & Patrawala, R. A. (2012). The use of dabigatran immediately after atrial fibrillation ablation. Journal of Cardiovascular Electrophysiology, 23(3), 264–268. doi:10.1111/j.1540-8167.2011.02175.x.

    Article  PubMed  Google Scholar 

  13. Yamaji, H., Murakami, T., Kawamura, H., Murakami, M., & Hina, K. (2012). Safety of dabigatran for atrial fibrillation ablation as a periprocedural anticoagulation strategy. Heart Rhythm, 9(5), S170.

    Google Scholar 

  14. Nin, T., Sairaku, A., Yoshida, Y., Kamiya, H., Tatematsu, Y., Nanasato, M., et al. (2012). A randomized controlled trial of dabigatran versus warfarin for periablation anticoagulation in patients undergoing ablation of atrial fibrillation. Pacing and Clinical Electrophysiology, 36(2), 172-179. doi:10.1111/pace.12036.

    Article  PubMed  Google Scholar 

  15. Gangireddy, S., Coffey, J. O., Calenda, B. W., Teh, A., Miller, M., Skipitaris, N. T., et al. (2012). The incidence of stroke after atrial fibrillation ablation in patients on dabigatran. Heart Rhythm, 9(5), S472.

    Google Scholar 

  16. Mendoza, I., Helguera, M., Baez-Escudero, J., Reina, J., & Pinski, S. L. (2012). Atrial fibrillation ablation on uninterrupted anticoagulation with dabigatran versus warfarin. Heart Rhythm, 9(5), S270–S271. Abstract.

    Google Scholar 

  17. Rowley, C. P., Bradford, N. S., Bernard, M. L., Sidney, D. S., Brabham, W. W., Netzler, P. C., et al. (2012). Complications of atrial fibrillation ablation in patients anticoagulated with dabigatran compared to warfarin. Heart Rhythm, 9(5), S201.

    Google Scholar 

  18. Ellis, C. R., Streur, M. M., & Nagarakanti, R. (2012). Safety and efficacy of dabigatran versus warfarin in patients undergoing left atrial catheter ablation. Heart Rhythm, 9(5), S421.

    Google Scholar 

  19. Lakkireddy, D., Reddy, Y. M., Di Biase, L., Vanga, S. R., Santangeli, P., Swarup, V., et al. (2012). Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation results from a multicenter prospective registry. Journal of the American College of Cardiology, 59(13), 1168–1174. doi:10.1016/j.jacc.2011.12.014.

    Article  PubMed  CAS  Google Scholar 

  20. Kaseno, K., Naito, S., Nakamura, K., Sakamoto, T., Sasaki, T., Tsukada, N., et al. (2012). Efficacy and safety of periprocedural dabigatran in patients undergoing catheter ablation of atrial fibrillation. Circulation journal, 76(10), 2337–42.

    Article  PubMed  CAS  Google Scholar 

  21. Snipelisky, D., Kauffman, C., Prussak, K., Johns, G., Venkatachalam, K., & Kusumoto, F. (2012). A comparison of bleeding complications post-ablation between warfarin and dabigatran. Journal of Interventional Cardiac Electrophysiology, 35(1), 29–33. doi:10.1007/s10840-012-9708-z.

    Article  PubMed  Google Scholar 

  22. Kim, J. S., She, F., Jongnarangsin, K., Chugh, A., Latchamsetty, R., Ghanbari, H., et al. (2012). Dabigatran vs warfarin for radiofrequency catheter ablation of atrial fibrillation. Heart Rhythm. doi:10.1016/j.hrthm.2012.12.011.

    Google Scholar 

  23. Maddox, W., Kay, G. N., Yamada, T., Osorio, J., Doppalapudi, H., Plumb, V. J., et al. (2013). Dabigatran versus warfarin therapy for uninterrupted oral anticoagulation during atrial fibrillation ablation. Journal of Cardiovascular Electrophysiology, n/a-n/a. doi:10.1111/jce.12143.

    Google Scholar 

  24. Haines, D. E., Mead-Salley, M., Salazar, M., Marchlinski, F. E., Zado, E., Calkins, H., et al. (2013). Dabigatran versus warfarin anticoagulation before and after catheter ablation for the treatment of atrial fibrillation. Journal of Interventional Cardiac Electrophysiology. doi:10.1007/s10840-013-9800-z.

  25. Bassiouny, M., Saliba, W., Rickard, J., Shao, M., Sey, A., Diab, M., et al. (2013). Use of dabigatran for peri-procedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation. Circulation Arrhythm Electrophysiology, Epub. doi:10.1161/circep.113.000320.

    Google Scholar 

  26. Boehringer-Ingelheim. (2010). Dabigatran prescribing information. http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf. Accessed 14 May 2011.

  27. Cohen, M., Mahaffey, K. W., Pieper, K., Pollack, C. V., Jr., Antman, E. M., Hoekstra, J., et al. (2006). A subgroup analysis of the impact of prerandomization antithrombin therapy on outcomes in the SYNERGY trial: enoxaparin versus unfractionated heparin in non-ST-segment elevation acute coronary syndromes. Journal of the American College of Cardiology, 48(7), 1346–1354. doi:10.1016/j.jacc.2006.05.058.

    Article  PubMed  CAS  Google Scholar 

  28. White, H. D., Chew, D. P., Hoekstra, J. W., Miller, C. D., Pollack, C. V., Jr., Feit, F., et al. (2008). Safety and efficacy of switching from either unfractionated heparin or enoxaparin to bivalirudin in patients with non-ST-segment elevation acute coronary syndromes managed with an invasive strategy: results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Journal of the American College of Cardiology, 51(18), 1734–1741. doi:10.1016/j.jacc.2007.12.052.

    Article  PubMed  CAS  Google Scholar 

  29. Huang, C., Siu, M., Vu, L., Wong, S., & Shin, J. (2012). Factors influencing doctors’ selection of dabigatran in non-valvular atrial fibrillation. Journal of Evaluation in Clinical Practice, Epub. doi:10.1111/j.1365-2753.2012.01886.x.

    Google Scholar 

  30. Eikelboom, J. W., Wallentin, L., Connolly, S. J., Ezekowitz, M., Healey, J. S., Oldgren, J., et al. (2011). Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation, 123(21), 2363–2372. doi:10.1161/circulationaha.110.004747.

    Article  PubMed  CAS  Google Scholar 

  31. Healey, J. S., Eikelboom, J., Douketis, J., Wallentin, L., Oldgren, J., Yang, S., et al. (2012). Peri-procedural bleeding and thromboembolic events with dabigatran compared to warfarin: results from the RE-LY Randomized Trial. Circulation, 126(3), 343–348. doi:10.1161/circulationaha.111.090464.

    Article  PubMed  CAS  Google Scholar 

  32. Schirmer, S. H., Baumhakel, M., Neuberger, H. R., Hohnloser, S. H., van Gelder, I. C., Lip, G. Y., et al. (2010). Novel anticoagulants for stroke prevention in atrial fibrillation: current clinical evidence and future developments. Journal of the American College of Cardiology, 56(25), 2067–2076. doi:10.1016/j.jacc.2010.09.017.

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

This project was supported (in part) by funding from the Agency of Healthcare Research and Quality through cooperative agreement number 1U19 HS021092. Dr. Steinberg was funded by NIH T-32 training grant #5 T32 HL 7101-37.

Conflict of interest

Drs. Steinberg and Hasselblad have no relevant disclosures. Dr. Atwater receives grants for clinical research from the American Heart Association and Medtronic and serves on an advisory board for Medtronic. Dr. Bahnson receives research funds from Medtronic and St. Jude Medical and participates as a consultant and/or speaker for Boehringer Ingelheim, ChanRX, Sequel Pharma, and Sanofi-Aventis. Dr. Alexander receives institutional research support from Bristol Myers Squibb, Pfizer, and Regado Biosciences and is a consultant to Bayer, Bristol Myers Squibb, Daiichi Sankyo, Janssen Pharmaceuticals, and Pfizer. Dr. Daubert receives research support from Boston Scientific, St. Jude, Medtronic, and Biosense Webster; institutional fellowship support from Boston Scientific, St. Jude, Medtronic, Biosense Webster, and Bard; and honoraria for advisory board participation or lectures from Biosense Webster, Sanofi-Aventis, Boston Scientific, and Sorin Medical. Dr. Piccini receives grants for clinical research from Johnson & Johnson and Boston Scientific and is a consultant to Forest Research Laboratories, Janssen Pharmaceuticals, Medtronic, and Titan Pharmaceuticals. A full list of Dr. Piccini and Dr. Alexander’s disclosures can be found at https://www.dcri.org/about-us/conflict-of-interest.

Author information

Authors and Affiliations

  1. Duke Center for Atrial Fibrillation, Electrophysiology Section, Duke University Medical Center, Durham, NC, USA

    Benjamin A. Steinberg, Brett D. Atwater, Tristram D. Bahnson, James P. Daubert & Jonathan P. Piccini

  2. Duke Clinical Research Institute, Durham, NC, USA

    Benjamin A. Steinberg, Vic Hasselblad, Tristram D. Bahnson, John H. Alexander, James P. Daubert & Jonathan P. Piccini

  3. Duke Heart Center, Durham, NC, USA

    Jeffrey B. Washam

Authors
  1. Benjamin A. Steinberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Vic Hasselblad
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Brett D. Atwater
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Tristram D. Bahnson
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jeffrey B. Washam
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. John H. Alexander
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. James P. Daubert
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Jonathan P. Piccini
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jonathan P. Piccini.

Appendix

Appendix

Table 4 Sensitivity meta-analysis after excluding studies where low-molecular weight heparin bridging was used
Full size table

Rights and permissions

Reprints and permissions

About this article

Cite this article

Steinberg, B.A., Hasselblad, V., Atwater, B.D. et al. Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: a meta-analysis of observational studies. J Interv Card Electrophysiol 37, 213–221 (2013). https://doi.org/10.1007/s10840-013-9813-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10840-013-9813-7

Keywords

Search

Navigation