Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation
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Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. / Calkins, Hugh; Willems, Stephan; Gerstenfeld, Edward P; Verma, Atul; Schilling, Richard; Hohnloser, Stefan H; Okumura, Ken; Serota, Harvey; Nordaby, Matias; Guiver, Kelly; Biss, Branislav; Brouwer, Marc A; Grimaldi, Massimo; RE-CIRCUIT Investigators.
in: NEW ENGL J MED, Jahrgang 376, Nr. 17, 27.04.2017, S. 1627-1636.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation
AU - Calkins, Hugh
AU - Willems, Stephan
AU - Gerstenfeld, Edward P
AU - Verma, Atul
AU - Schilling, Richard
AU - Hohnloser, Stefan H
AU - Okumura, Ken
AU - Serota, Harvey
AU - Nordaby, Matias
AU - Guiver, Kelly
AU - Biss, Branislav
AU - Brouwer, Marc A
AU - Grimaldi, Massimo
AU - RE-CIRCUIT Investigators
PY - 2017/4/27
Y1 - 2017/4/27
N2 - 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 .).
AB - 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 .).
KW - Aged
KW - Anticoagulants/administration & dosage
KW - Atrial Fibrillation/drug therapy
KW - Catheter Ablation
KW - Dabigatran/administration & dosage
KW - Female
KW - Hemorrhage/chemically induced
KW - Humans
KW - Incidence
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Postoperative Complications/chemically induced
KW - Stroke/prevention & control
KW - Warfarin/administration & dosage
U2 - 10.1056/NEJMoa1701005
DO - 10.1056/NEJMoa1701005
M3 - SCORING: Journal article
C2 - 28317415
VL - 376
SP - 1627
EP - 1636
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 17
ER -
