title: Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: a meta-analysis of observational studies.
abstract: OBJECTIVE
  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.
authors.affiliation: Duke Center for Atrial Fibrillation, Electrophysiology Section, Duke University Medical Center, Durham, NC, USA.
authors.forename: Benjamin A
authors.initials: BA
authors.lastname: Steinberg
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
authors.forename: Brett D
authors.initials: BD
authors.lastname: Atwater
authors.forename: Tristram D
authors.initials: TD
authors.lastname: Bahnson
authors.forename: Jeffrey B
authors.initials: JB
authors.lastname: Washam
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
authors.forename: James P
authors.initials: JP
authors.lastname: Daubert
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage; D000991:Antithrombins / Q000008:administration & dosage; D001281:Atrial Fibrillation / Q000453:epidemiology* / Q000601:surgery*; D001562:Benzimidazoles / Q000008:administration & dosage*; D017115:Catheter Ablation / Q000706:statistics & numerical data*; D015897:Comorbidity; D000069604:Dabigatran; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D064887:Observational Studies as Topic / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011292:Premedication / Q000706:statistics & numerical data; D012307:Risk Factors; D013923:Thromboembolism / Q000453:epidemiology* / Q000517:prevention & control*; D016896:Treatment Outcome; D015091:beta-Alanine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran