Uninterrupted dabigatran versus warfarin for ablation in atrial fibrillation

Research output: Contribution to journalArticle

Abstract

BACKGROUND 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. METHODS In this randomized, open-label, multicenter, controlled trial with blinded adjudicated end-point assessments, we randomly assigned patients scheduled for catheter ablation of paroxysmal or persistent atrial fibrillation to receive either dabigatran (150 mg twice daily) or warfarin (target international normalized ratio, 2.0 to 3.0). Ablation was performed after 4 to 8 weeks of uninterrupted anticoagulation, which was continued during and for 8 weeks after ablation. The primary end point was the incidence of major bleeding events during and up to 8 weeks after ablation; secondary end points included thromboembolic and other bleeding events. RESULTS The trial enrolled 704 patients across 104 sites; 635 patients underwent ablation. Baseline characteristics were balanced between treatment groups. The incidence of major bleeding events during and up to 8 weeks after ablation was lower with dabigatran than with warfarin (5 patients [1.6%] vs. 22 patients [6.9%]; absolute risk difference,-5.3 percentage points; 95% confidence interval,-8.4 to-2.2; P<0.001). Dabigatran was associated with fewer periprocedural pericardial tamponades and groin hematomas than warfarin. The two treatment groups had a similar incidence of minor bleeding events. One thromboembolic event occurred in the warfarin group. CONCLUSIONS In patients undergoing ablation for atrial fibrillation, anticoagulation with uninterrupted dabigatran was associated with fewer bleeding complications than uninterrupted warfarin. (Funded by Boehringer Ingelheim; RE-CIRCUIT ClinicalTrials.gov number, NCT02348723.)

Original languageEnglish (US)
Pages (from-to)1627-1636
Number of pages10
JournalNew England Journal of Medicine
Volume376
Issue number17
DOIs
StatePublished - Apr 27 2017

    Fingerprint

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Calkins, H., Willems, S., Gerstenfeld, E. P., Verma, A., Schilling, R., Hohnloser, S. H., Okumura, K., Serota, H., Nordaby, M., Guiver, K., Biss, B., Brouwer, M. A., & Grimaldi, M. (2017). Uninterrupted dabigatran versus warfarin for ablation in atrial fibrillation. New England Journal of Medicine, 376(17), 1627-1636. https://doi.org/10.1056/NEJMoa1701005