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UK & IRELAND HEALTHCARE PROFESSIONALS

Click here if you are a healthcare professional and would like more information on Pradaxa® (dabigatran etexilate)


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PATIENTS PRESCRIBED PRADAXA®/ MEMBERS OF THE PUBLIC IN THE UK & IRELAND

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PC-GB -101423 V1 August 2020

Uninterrupted Pradaxa®
150mg b.d. vs uninterrupted
warfarin in patients with NVAF
undergoing catheter ablation:
The RE-CIRCUIT Study

Pradaxa® is indicated for stroke prevention in adult patients with NVAF with one or more risk factors for stroke.1,2 The RE-CIRCUIT trial provides additional safety data to help clinicians make informed decisions for NVAF patients who are already taking Pradaxa® and need to undergo catheter ablation.3

 

Using Pradaxa® in patients undergoing catheter ablation

Catheter ablation for symptomatic atrial fibrillation is widely performed, and whilst the risk of procedure-related thromboembolism has been estimated to be between only 0% and 7%, the potential consequences may be life-threatening.4

Systemic anticoagulation is essential before, during and after ablation for atrial fibrillation in order to prevent thromboembolic events, such as stroke or transient ischaemic attack. However, it is important to balance the risk of bleeding versus the risk of stroke during the procedure.4 Consequently, the RE-CIRCUIT trial was undertaken to assess the safety of uninterrupted anticoagulation with Pradaxa® (dabigatran etexilate) versus uninterrupted warfarin.3

These data can help you make informed decisions for your NVAF patients who are already taking Pradaxa® and need to undergo catheter ablation.3

The RE-CIRCUIT trial in summary:
Trial design and key findings

In this short video, Dr Kim Rajappan (Consultant Cardiologist at the John Radcliffe Hospital, Oxford) provides a broad overview of the RE-CIRCUIT trial design and key findings from the study, including the significantly reduced incidence of major bleeding events seen with uninterrupted Pradaxa® 150mg b.d. versus uninterrupted warfarin.3

RE-CIRCUIT study design

RE-CIRCUIT was a randomised, open-label, multicentre controlled trial of adult patients scheduled for catheter ablation of paroxysmal or persistent NVAF.3

Patients received either Pradaxa® 150mg b.d. or warfarin (target international normalised ratio, 2.0 to 3.0).3

Ablation was performed after 4 to 8 weeks of uninterrupted anticoagulation, which was continued during and for 8 weeks after ablation.3

Patients with paroxysmal or persistent non-valvular AF schedule with NOAC Pradaxa® (dabigatran etexilate) vs warfarin
Patients with paroxysmal or persistent non-valvular AF schedule with NOAC Pradaxa® (dabigatran etexilate) vs warfarin

In line with the guidelines:4

  • Continuous anticoagulation in both treatment arms
  • TOE was performed on all patients ≤48 hrs before ablation
  • UFH was administered before or immediately after transseptal puncture (adjusted to maintain ACT >300s)

RE-CIRCUIT study endpoints

  • The primary end point was the incidence of ISTH major bleeding events during and up to 8 weeks after ablation3
  • Secondary end points included thromboembolic events (a composite of stroke, systemic embolism, or TIA), minor bleeding events, and a composite of major bleeding events and thromboembolic events (stroke, systemic embolism, or TIA)3

What do the outcomes of the
RE-CIRCUIT trial mean for you and
your patients?

Anticoagulation with uninterrupted Pradaxa® 150mg b.d. was associated with a significantly reduced incidence of major bleeding events versus uninterrupted warfarin3

ISTH major bleeding

ISTH major bleeding outcomes with NOAC Pradaxa (dabigatran) vs warfarin
ISTH major bleeding outcomes with NOAC Pradaxa (dabigatran) vs warfarin
  • Pradaxa® 150mg b.d. was associated with fewer pericardial tamponades and groin hematomas than warfarin3
  • There were no thromboembolic events with Pradaxa® 150mg b.d., and 1 event (TIA) in a patient taking warfarin3
  • The incidence of minor bleeding events was similar between the two groups3
  • The incidence of the composite major bleeding and thromboembolic events was lower with Pradaxa® 150mg b.d. versus warfarin (5 patients [1.6%] vs. 23 patients [7.2%])3
  • Although Praxbind® became available during the RE-CIRCUIT trial, all Pradaxa®  major bleeding events were managed without the need for Praxbind®3

The reduced risk of bleeding with uninterrupted Pradaxa® 150mg b.d. provides reassurance to electrophysiologists performing catheter ablation for AF, while the additional safety data from the RE-CIRCUIT trial may help you make informed decisions for your NVAF patients who are already taking Pradaxa® and need to undergo catheter ablation.3

Key aspects of the RE-CIRCUIT trial that
help support use in clinical practice

In this video, Dr Kim Rajappan provides further insights into aspects of the RE-CIRCUIT trial that have increased his own confidence to routinely perform procedures on interrupted Pradaxa®, including the robust trial design and the large number of patients and centre that participated in the study.

RE-CIRCUIT: Expert answers
to commonly asked questions

In these short videos, Dr Kim Rajappan (Consultant Cardiologist and Electrophysiologist, John Radcliffe Hospital, Oxford) answers commonly asked questions on the RE-CIRCUIT trial.

What was the rationale for carrying out the RE-CIRCUIT trial?

KEY TAKEAWAY: The aim of the RE-CIRCUIT trial was to provide additional safety data to help clinicians make informed decisions for NVAF patients who are already taking Pradaxa® and need to undergo catheter ablation.3

Why was a TOE performed?

KEY TAKEAWAY: A transesophageal echocardiography (TOE) was performed to exclude left atrial thrombis.3

Why was the ISTH definition of major bleeding chosen?

KEY TAKEAWAY: The ISTH definition was chosen because it is a standardised set of criteria used widely across studies evaluating haemostasis.3

How much heparin was used during the procedure?

KEY TAKEAWAY: Heparin was administered before or immediately after transseptal puncture and was monitored regularly to keep activated clotting time (ACT) above 300 seconds, in-line with international guidance. This is important to reduce the risk of thromboembolic events.3

What types of ablation techniques were used?

KEY TAKEAWAY: A variety of ablation techniques were used in RE-CIRCUIT including radiofrequency ablation, cryoablation, linear ablation and laser balloon ablation.3

What could be the explanation for the higher rate of major bleeding and in particular tamponade in the warfarin arm?

KEY TAKEAWAY: Because Pradaxa® is a direct thrombin inhibitor and acts on a specific part of the coagulation cascade1,2, it may be able to reduce bleeding compared to warfarin which is a less specific anticoagulant and affects various aspects of the coagulation cascade.

When would you consider continuing anticoagulation beyond the recommended 8 weeks after the ablation?

KEY TAKEAWAY: Continue anticoagulation beyond 8 weeks after ablation if the patient has a CHA₂DS₂-VASc score ≥2. In patients with a CHA₂DS₂-VASc score of 1, other factors that are not included in the CHA₂DS₂-VASc score should be considered.

Abbreviations

ACT — activated clotting time

AF — atrial fibrillation

ARR — absolute risk reduction

CI — confidence interval

INR — international normalised ratio

ISTH — International Society on Thrombosis and Haemostasis

NVAF — non-valvular atrial fibrillation

R — randomisation

RRR — relative risk reduction

TIA — transient ischaemic attack

TOE — transoesophageal echocardiography

References
  1. Pradaxa 110mg hard capsules Summary of Product Characteristics
  2. Pradaxa 150mg hard capsules Summary of Product Characteristics 
  3. Calkins H, et al. N Engl J Med 2017;376(17):1627-1636
  4. Calkins H, et al. Europace 2012;14(4):528-606
  5. Calkins H, et al. Europace 2018;20(1):e1-e160
PC-GB-100836 V1 | July 2020

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