About RE-DUAL PCI
RE-DUAL PCI (NCT02164864) evaluates dual therapy with dabigatran etexilate mesylate vs. triple therapy with warfarin in atrial fibrillation patients who have undergone PCI with stenting.

RE-DUAL PCI has randomized 2,727 adult patients who have undergone PCI with stenting (elective or due to an acute coronary syndrome) at 550 sites in over 40 countries worldwide.
The main objective of the study is to compare a dual antithrombotic therapy regimen of either 150mg or 110mg dabigatran etexilate mesylate twice daily plus clopidogrel or ticagrelor versus a triple antithrombotic therapy combination of warfarin plus clopidogrel or ticagrelor plus aspirin <= 100mg once daily.

The primary safety endpoint of the 30 month study is the time to first major bleeding event, as defined by the International Society on Thrombosis and Haemostasis (ISTH), or clinically relevant non-major bleeding event. The secondary outcome measures include composite efficacy endpoints of time to death or first thrombotic event (all death, myocardial infarction, stroke or systemic embolism) and unplanned revascularization.

About Percutaneous Coronary Intervention (PCI)
Patients with atrial fibrillation who undergo PCI with stenting are at increased risk of serious complications caused by blood clots, including stroke, systemic embolism, heart attacks, blood clots on the stents and potentially even death. Antithrombotic therapy is required to decrease patients' risk of suffering blood clots and their consequences.

These patients need antiplatelets to reduce their risk of stent thrombosis and anticoagulation to reduce the risk of stroke. The combination of dual antiplatelet therapy and anticoagulation up to now has been a major challenge and has led to frequent bleeding complications. Addressing this challenge is at the heart of research in this area.

About Pradaxa (dabigatran etexilate mesylate)

Indications and Usage
Pradaxa (dabigatran etexilate mesylate) capsules is indicated:
• to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including Pradaxa, increases the risk of thrombotic events. If anticoagulation with Pradaxa is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

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