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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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PC-GB -101423 V1 August 2020

Dual antithrombotic therapy with Pradaxa® vs warfarin triple therapy in patients with NVAF who have undergone PCI with stenting:
The RE-DUAL PCI Study

Pradaxa®(dabigatran etexilate) is indicated for stroke prevention in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors for stroke.1,2 The RE-DUAL PCI trial provides additional safety data to help clinicians make informed decisions for NVAF patients who are already taking Pradaxa® and need to undergo percutaneous coronary intervention (PCI).3

Standard of care for your patients with NVAF who require PCI involves an anticoagulant to reduce stroke risk, and typically two antiplatelets (known as triple antithrombotic therapy) to prevent stent thrombosis and thromboembolic events. However, triple antithrombotic therapy is associated with an increased bleeding risk, which could be a concern for you and your patients.4

Consequently, the RE-DUAL trial was undertaken to assess the safety of Pradaxa® (dabigatran etexilate) dual therapy versus warfarin triple therapy. These data can help you make informed decisions for your NVAF patients who are already taking Pradaxa® and need to undergo PCI with stenting.3

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

This short video provides a broad overview of the RE-DUAL PCI trial design and key findings from the study, including the significantly reduced incidence of bleeding events seen with both doses of Pradaxa® dual therapy versus warfarin triple therapy.3

RE-DUAL PCI study design

RE-DUAL PCI was a multicentre, open-label controlled trial that compared the safety and efficacy of Pradaxa® dual therapy with warfarin triple therapy in 2725 patients with atrial fibrillation who had undergone PCI. After PCI, patients were randomly assigned to:3

  • Triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) OR
  • Dual therapy with dabigatran (110 mg or 150 mg b.d.) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin

All patients were to receive a P2Y12 inhibitor for 12 months. Mean follow-up was 14 months.3

RE-DUAL PCI trial design
RE-DUAL PCI trial design

RE-DUAL PCI study endpoints

  • The primary endpoint was an ISTH major or clinically relevant non-major bleeding event during follow-up3
  • The efficacy endpoint was a composite of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularisation3

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

Both doses of Pradaxa® dual therapy were associated with significantly less major or clinically-relevant non-major bleeding versus warfarin triple therapy.3

ISTH major or clinically-relevant non-major bleeding

RE-DUAL PCI outcomes
RE-DUAL PCI outcomes
  • Pradaxa® dual therapy (both doses combined) was non-inferior to warfarin triple therapy for the composite efficacy endpoint (thromboembolic events, death, or unplanned revascularisation)3
  • RE-DUAL PCI used doses of Pradaxa® approved for stroke prevention in NVAF1-3
  • NVAF patients who require PCI can stay on the Pradaxa® dose they are already using for stroke prevention, providing simple, uninterrupted protection against stroke without dose modification3

     

RE-DUAL PCI: Expert answers
to commonly-asked questions

In these short videos, Dr Kelvin Lee (Consultant Cardiologist, Lincoln County Hospital) answers commonly asked questions about the RE-DUAL PCI trial.

Why was dual therapy used in RE-DUAL PCI instead of triple therapy?

KEY TAKEAWAY: Antiplatelet strategies in patients with NVAF undergoing PCI have been evolving. RE-DUAL PCI aimed to investigate whether a NOAC plus a single antiplatelet would improve safety and maintain efficacy compared to warfarin triple therapy. Using Pradaxa® with a single antiplatelet resulted in significantly less bleeding than warfarin triple therapy with no difference in the incidence of thromboembolic events.3

Why do the doses of Pradaxa® investigated in RE-DUAL PCI matter?

KEY TAKEAWAY: Patients with NVAF can stay on their Pradaxa® dose for stroke prevention (110mg b.d. or 150mg b.d.), with an antiplatelet added for one year. After 1 year, patients discontinue the antiplatelet and continue to take Pradaxa® at the same dose, thereby providing simple, uninterrupted protection against stroke without dose modification.1,2,5

Are there differences in outcomes based on the P2Y12 inhibitor used?

KEY TAKEAWAY: A pre-specified sub analysis of RE-DUAL PCI showed that outcomes with Pradaxa® dual therapy vs warfarin triple therapy were maintained regardless of whether clopidogrel or ticagrelor was used alongside Pradaxa®.6

Was there a difference in outcomes in patients who received bare-metal vs drug-eluting stents in RE-DUAL PCI?

KEY TAKEAWAY: A pre-specified sub analysis of RE-DUAL PCI showed that outcomes with Pradaxa® dual therapy vs warfarin triple therapy were maintained regardless of the type of stent used.6

Abbreviations

ARR — absolute risk reduction

ISTH —  International Society on Thrombosis and Haemostasis

NOAC — non-Vitamin K antagonist oral anticoagulant

NVAF — non-valvular atrial fibrillation

PCI — percutaneous coronary intervention

RRR —  relative risk reduction

References
  1. Pradaxa® 110mg hard capsules Summary of Product Characteristics
  2. Pradaxa® 150mg hard capsules Summary of Product Characteristics
  3. Cannon CP, et al. N Engl J Med 2017;377(16):1513–1524.
  4. Andrade JG, et al. Can J Cardiol 2013;29:204–12.
  5. Steffel J, et al. Eur Heart J 2018;39:1330–1393.
  6. Oldgren J, et al. Eur Heart J 2019;40(19):1553–1562.
PC-GB-100835 V1 | August 2020

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