The efficacy and safety of Pradaxa® (dabigatran etexilate) for stroke prevention
in NVAF is supported by randomised
controlled trials and independent
real-world data
Randomised controlled trials
for Pradaxa® (dabigatran etexilate)
The efficacy and safety of Pradaxa® (dabigatran etexilate) has been evaluated in ten key phase III/IV studies for stroke prevention in atrial fibrillation, including over 23,000 patients recieving Pradaxa®.5
Overview of key trials in patients with NVAF
The RE-LY trial
RE-LY® was a phase III, prospective, randomised, open-label, blinded endpoint trial which compared the efficacy and safety of Pradaxa® with warfarin for the prevention of stroke or systemic embolism in patients with NVAF.1–3
The trial enrolled 18,113 patients with NVAF with at least one additional risk factor for stroke or systemic embolism. Patients were randomised to receive blinded fixed doses of Pradaxa® 110mg (n=6,015) or 150mg b.d. (n=6,076) or open-label, dose-adjusted warfarin (target INR 2.0–3.0) (n=6,022).1–3
The primary outcome was stroke or systemic embolism. The primary safety outcome was major bleeding. The median duration of follow-up was 2.0 years.1–3
RE-LY key findings:
- Pradaxa® 150mg b.d. significantly reduced the risk of stroke and systemic embolism, ischaemic stroke, haemorrhagic stroke and intracranial bleeding vs warfarin, with a similar risk of major bleeding1–4
- Pradaxa® 110mg b.d. was was non-inferior to warfarin for the prevention of stroke and systemic embolism and ischaemic stroke, and significantly reduced the risk of major bleeding, intracranial bleeding and haemorrhagic stroke vs warfarin1–3,5
The RE-LY trial demonstrates the efficacy and safety of both doses of Pradaxa® for stroke prevention in patients with NVAF 1–5 and is the only RCT to have prospectively tested a low-dose NOAC in more than 6,000 patients.1–3
The RE-DUAL PCI trial
RE-DUAL PCI™ was a phase IIIb prospective, randomised, open label, blinded endpoint trial which compared the safety and efficacy of Pradaxa® dual therapy with warfarin triple therapy in 2,725 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) with stenting.6
After PCI, patients were randomised to receive dual therapy with Pradaxa® 150mg or 110mg b.d. plus a P2Y12 inhibitor (clopidogrel or ticagrelor), or triple therapy with warfarin (INR 2.0-3.0) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months). All patients received a P2Y12 inhibitor for at least 12 months.
The primary endpoint was ISTH major or clinically relevant non-major bleeding. The efficacy endpoint was the composite of thrombotic events (myocardial infarction, or stroke, or systemic embolism), death, or unplanned revascularisation. Mean follow-up was 14 months.6
RE-DUAL PCI key findings:
- Both doses of Pradaxa® dual therapy significantly reduced the risk of bleeding compared to warfarin triple therapy in patients with NVAF who had undergone PCI with stenting6
- There was no difference in the risk of thrombotic events, death or unplanned revascularization with Pradaxa® dual therapy (both doses combined) vs warfarin triple therapy6
The RE-DUAL PCI trial shows that should your NVAF patient ever have to undergo PCI, they can remain on their stroke prevention dose after the procedure.6
The RE-CIRCUIT trial
RE-CIRCUIT was a phase IV, prospective, randomised, open-label, blinded endpoint trial which compared the safety and efficacy of uninterrupted Pradaxa® 150mg twice daily with uninterrupted warfarin (INR 2.0–3.0) in 678 patients undergoing catheter ablation of paroxysmal or persistent atrial fibrillation.7
Ablation was performed after 4 to 8 weeks of uninterrupted anticoagulation, which was continued during and for 8 weeks after ablation.7
The primary endpoint was ISTH major bleeding during and up to 8 weeks after ablation. The secondary efficacy endpoint was thrombotic events (composite of stroke, systemic embolism or TIA).7
RE-CIRCUIT key findings:
- Uninterrupted Pradaxa® 150mg b.d. significantly reduced the risk of major bleeding during and after ablation in NVAF patients vs uninterrupted warfarin7
- There were no thromboembolic events with Pradaxa®, and 1 event (TIA) in a patient taking warfarin7
The RE-CIRCUIT trial shows that should your NVAF patients ever have to undergo catheter ablation Pradaxa® 150mg b.d. can simply continue to be prescribed as usual without having to worry about treatment interruptions, with the added benefit of a lower risk of major bleeding vs uninterrupted warfarin and a specific reversal agent.7,8
Real-world studies for
Pradaxa® (dabigatran etexilate)
The safety and efficacy of Pradaxa® for stroke prevention in NVAF demonstrated in RCTs is supported by independent real-world studies involving over 675,000 patients receiving Pradaxa® for stroke prevention.9
GI — gastrointestinal
INR — International normalised ratio
ISTH — International Society on Thrombosis and Haemostasis
NOAC — non-vitamin K antagonist oral anticoagulant
NVAF — non-valvular atrial fibrillation
PCI — percutaneous coronary intervention
RCT — randomised controlled trials
TIA — transient ischaemic attack
- Connolly SJ, et al. N Engl J Med 2009;361:1139–1151.
- Connolly SJ, et al. N Engl J Med 2010;363:1875–1876.
- Connolly SJ, et al. N Engl J Med 2014;371:1464–1465.
- Pradaxa® 150mg hard capsules Summary of Product Characteristics.
- Pradaxa® 110mg hard capsules Summary of Product Characteristics.
- Cannon CP, et al. N Engl J Med 2017;377(16):1513–1524.
- Calkins H, et al. N Engl J Med 2017;376(17):1627–1636.
- Praxbind® Summary of Product Characteristics.
- Boehringer Ingelheim Data on File: DBG 19–03.