The TGA has signed off on a change to prescribing information for dabigatran (Pradaxa) confirming it as the only NOAC that can be continued in patients with atrial fibrillation undergoing a catheter ablation for rhythm control.
The change is consistent with the recently published NHFA/CSANZ Australia Clinical Guidelines for the Diagnosis and Management of Atrial Fibrillation (AF) 2018.
The guidelines recommend only ‘uninterrupted warfarin or dabigatran be used preferentially as the OAC for patients undergoing catheter ablation because agents are available to rapidly reverse the anticoagulant action of both drugs’.
The recommendation was made following evidence including the 2017 RE-CIRCUIT trial which found uninterrupted treatment with dabigatran (150mg twice daily) in AF patients undergoing catheter ablation resulted in fewer bleeding complications than uninterrupted treatment with warfarin (1.6% v 6.9%).
The treatment groups had similar incidences of minor bleeding events and serious adverse events. There were no strokes or embolic events in the dabigatran group and only one TIA in the warfarin group.
Dr Andrei Catanchin, a cardiologist and electrophysiologist at Epworth Hospital in Melbourne, told the limbic interrupting anticoagulation was never ideal.
And especially given the increasing rates of cardiac ablation procedures for AF.
“It’s very important to have formal guidance for this invasive procedure which is being performed increasingly frequently. Uninterrupted warfarin was the accepted standard of care but warfarin use is challenging and more risky overall. It’s only benefit was its reversibility but of course dabigatran also has a reversal agent.”
He added that it was possible and likely that AF patients on other NOACs might be switched to dabigatran ahead of ablation so they were covered by a reversible agent.
“Because the NOACs have rapid on/offset of action, their administration can be tailored to suit specific patients’ and doctors’ needs and preferences.”