Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: a meta-analysis of observational studies
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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.
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.
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).
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.
KeywordsAtrial fibrillation Ablation Dabigatran Warfarin Meta-analysis
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.
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