Short-term dabigatran interruption before cardiac rhythm device implantation: multi-centre experience from the RE-LY trial

Europace. 2017 Oct 1;19(10):1630-1636. doi: 10.1093/europace/euw409.

Abstract

Aims: Cardiac implantable electronic device (CIED) surgery is commonly performed in patients with atrial fibrillation (AF). The current analysis was undertaken to compare peri-operative anticoagulation management, bleeding, and thrombotic events in AF patients treated with dabigatran vs. warfarin.

Methods and results: This study included 611 patients treated with dabigatran vs. warfarin who underwent CIED surgery during the RE-LY trial. Among 201 warfarin-treated patients, warfarin was interrupted a median of 144 (inter-quartile range, IQR: 120-216) h, and 37 (18.4%) patients underwent heparin bridging. In dabigatran-treated patients (216 on 110 mg bid and 194 on 150 mg bid), the duration of dabigatran interruption was a median of 96 (IQR: 61-158) h. Pocket hematomas occurred in 9 (2.20%) patients on dabigatran and 8 (3.98%) patients on warfarin (P = 0.218). The occurrence of pocket hematomas was lower with dabigatran compared with warfarin with heparin bridging (RD: -8.62%, 95% CI: -24.15 to - 0.51%, P = 0.034) but not when compared with warfarin with no bridging (P = 0.880). Ischemic stroke occurred in 2 (0.3%) patients; one in the warfarin group (without bridging) and one in the dabigatran 150 mg bid group (P = 0.735).

Conclusion: In patients treated with dabigatran undergoing CIED surgery, interruption of dabigatran is associated with similar or lower incidence of pocket hematoma, when compared with warfarin interruption without or with heparin bridging, respectively. Whether uninterrupted dabigatran can reduce pocket hematoma or ischemic stroke remains to be evaluated.

Keywords: Anticoagulation; Dabigatran; Device implantation; Hematoma; Warfarin.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects
  • Antithrombins / administration & dosage*
  • Antithrombins / adverse effects
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / drug therapy*
  • Dabigatran / administration & dosage*
  • Dabigatran / adverse effects
  • Defibrillators, Implantable*
  • Drug Administration Schedule
  • Drug Substitution
  • Female
  • Hematoma / chemically induced
  • Hemorrhage / chemically induced
  • Heparin / administration & dosage
  • Humans
  • Male
  • Middle Aged
  • Pacemaker, Artificial*
  • Prosthesis Implantation / adverse effects
  • Prosthesis Implantation / instrumentation*
  • Thrombosis / etiology
  • Thrombosis / prevention & control
  • Time Factors
  • Treatment Outcome
  • Warfarin / administration & dosage*
  • Warfarin / adverse effects

Substances

  • Anticoagulants
  • Antithrombins
  • Warfarin
  • Heparin
  • Dabigatran