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NOACs: translating latest clinical and cardioversion data into practice

In the latest ESC 2016 guidelines for the management of patients with atrial fibrillation (AF), it is now a Class 1A recommendation to use a non-vitamin K oral anticoagulant (NOAC) in preference to warfarin where a patient would otherwise be eligible for a NOAC for non-valvular AF. Warfarin is currently still recommended in patients with moderate-to-severe mitral stenosis and mechanical heart valves.

Dr Ian Menown (Craigavon Cardiac Centre, Northern Ireland) described the evidence base for the use of NOACs for anticoagulation in AF, including the findings of the ENGAGE-AF (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation) trial comparing the use of edoxaban vs. warfarin for AF. He noted the 20% reduction in major bleeding and reduced cardiovascular mortality seen in the secondary end-points of the trial.

Dr Ian Menown (Craigavon Cardiac Centre)

Dr Ian Menown (Craigavon Cardiac Centre)

The challenges faced in adequately anticoagulating a patient undergoing DC cardioversion are all too familiar to arrhythmia specialists. Contemporary guidelines recommend >3 weeks of therapeutic anticoagulation prior to elective DC cardioversion. Achieving and maintaining a stable INR with warfarin can often be challenging and can frequently lead to the cancellation or postponement of cardioversion.  In this context, Dr David Jones (Royal Brompton & Harefield NHS Trust, London) discussed the results from the recently published ENSURE-AF (Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation) trial where edoxaban was demonstrated to be a safe and effective alternative to warfarin in patients needing anticoagulation prior to elective DC cardioversion.

It was noted that adherence to edoxaban was very high in the trial setting. The study also included many patients with a low CHADSVasc score (0 or 1) likely representing a real world population. Although the trial was the largest randomised controlled trial (RCT) for a NOAC in the setting of DC cardioversion, the efficacy and safety event rates were low in both arms. The net clinical outcome was numerically lower but not statistically different in the edoxaban and enoxaparin/warfarin arm. Despite this, the ENSURE-AF trial suggests that patients needing anticoagulation prior to DC cardioversion may indeed benefit from edoxaban. Further work is needed to assess whether use of transoesophageal echocardiography can further reduce stroke risk and the minimal/optimal ‘run in’ period for NOAC anticoagulation (is three weeks enough/too long?).

Dr Menown provided important insights into deciding which anticoagulants should be used for different patients. While noting that due to different trial populations in the major NOAC trials, direct comparisons are difficult to make but various clinical factors and patient preference can help guide NOAC choice. The ROCKET-AF (rivaroxaban) and ENGAGE-AF (edoxaban) trials had a larger proportion of patients with higher CHADS2 score than RE-LY (dabigatran) and ARISTOTLE (apixaban). In network meta-analyses, edoxaban was favoured for major bleeding vs. dabigatran and rivaroxaban whilst having similar efficacy for prevention of stroke compared to other NOACs.

Based on this and other data, the speakers noted that in patients with a high bleeding risk, edoxaban or apixaban may be a better option compared to other anticoagulants. In patients with a high risk of ischaemic stroke but a low bleeding risk, dabigatran 150 mg may be a better option. In patients with renal impairment, apixaban, low-dose edoxaban or low dose rivaroxaban may be a better option. Taking into account patient surveys, patients tended to prefer rivaroxaban and edoxaban with their once daily regimens.

Published on: November 8, 2016

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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