• RE-DUAL PCI™ showed large reductions in the incidence of bleeding complications if Pradaxa® dual therapy was used instead of warfarin triple therapy
  • Both Pradaxa® doses tested in RE-DUAL PCI™ have been approved for stroke prevention in atrial fibrillation
  • Data were presented as a late-breaker at the ESC Congress 20171 and published in the New England Journal of Medicine2

INGELHEIM, Germany I August 27, 2017 I The RE-DUAL PCI trial explored anticoagulation with Pradaxa® (dabigatran etexilate) dual therapy without aspirin in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement: results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with Pradaxa® when compared to triple therapy with warfarin.1,2 The risk for the primary safety endpoint was 48% lower for Pradaxa® 110 mg dual therapy and 28% lower for Pradaxa® 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events. Both Pradaxa® doses have been approved by regulatory authorities around the world for stroke prevention in AF. The results were presented today as a late-breaker at the ESC Congress 20171 and have been simultaneously published in the New England Journal of Medicine.2

Approximately 20–30% of patients with AF who are continuously taking an oral anticoagulant (OAC) to reduce their risk of AF-related stroke have coexisting coronary artery disease and may require a PCI using stent placement to improve blood flow to the heart.3 The combination of potent antithrombotic therapies associated with triple therapy with warfarin and two antiplatelets is associated with high rates of major bleeding in these patients.4-7 RE-DUAL PCI tested an alternative treatment strategy: dual therapy with Pradaxa® and a single antiplatelet, but without aspirin.

“For physicians treating patients with atrial fibrillation who have undergone percutaneous coronary intervention with stent placement, it is paramount to balance the efficacy required with the risk of bleeding,” said Christopher Cannon, MD, cardiologist at Brigham and Women’s Hospital, lead investigator of RE-DUAL PCI, and executive director of the Cardiometabolic Trials at the Baim Institute for Clinical Research. “Previously we did not have a lot of dedicated data on non-vitamin K oral anticoagulants in this setting; the results from RE-DUAL PCI are relevant to fellow physicians who care for these types of patients and are looking for an effective antithrombotic treatment regimen.”

The results were:1,2

  • Incidence of primary endpoint (time to major or clinically relevant non-major bleeding event):

o 15.4% for Pradaxa® 110 mg dual therapy versus 26.9% for warfarin triple-therapy, which translates into a 48% lower risk

o 20.2% for Pradaxa® 150 mg dual-therapy versus 25.7% for warfarin triple therapy, which translates into a 28% lower risk

  • Both Pradaxa® dual therapy groups also showed lower rates of major bleeding (when analysed alone, both for the ISTH* and the TIMI** major bleeding definitions) and total bleeding
  • Key secondary endpoint (combining death, myocardial infarction, stroke, systemic embolism and unplanned revascularisation):
  • Similar rates of events were observed: 13.7% for the two Pradaxa® dual therapy groups combined, versus 13.4% for warfarin triple therapy

“The results we have seen from RE-DUAL PCI are another great piece of evidence on the benefit Pradaxa® can offer patients with atrial fibrillation and their treating physicians; a benefit which has been shown in many situations along the treatment journey,” commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Especially if you also take into account other recent data like the RE-CIRCUIT study in catheter ablation, evidence from ‘real-world studies’ or the results of the RE-VERSE AD study in emergency situations. Together, these data paint a really compelling picture of the safety and efficacy profile of Pradaxa.”1,2, 8-18



RE-DUAL PCI evaluates dual therapy with dabigatran etexilate and single antiplatelet therapy (but no aspirin) versus triple therapy with warfarin and two antiplatelet agents including aspirin in AF patients following PCI with stenting.1,2,19

RE-DUAL PCI has randomised 2,725 adult patients undergoing PCI with stenting (elective or due to an acute coronary syndrome) at 414 sites in over 41 countries worldwide.1

The main objective of the study is to compare a dual antithrombotic therapy regimen of either 110 mg or 150 mg dabigatran etexilate twice daily plus clopidogrel or ticagrelor versus a triple antithrombotic therapy combination of warfarin plus clopidogrel or ticagrelor plus aspirin <= 100 mg once daily.1,2,19

The primary safety endpoint of the 30 month study is the non-inferiority in 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 key thromboembolic endpoint tested for non-inferiority was the composite endpoint of time to death, first thrombotic event (myocardial infarction, stroke or systemic embolism) and unplanned revascularisation.1,2,19

About Percutaneous Coronary Intervention (PCI)

PCI is a medical intervention where stents are used to widen a blockage in arteries of the heart in patients with coronary artery disease.20 This intervention is conducted to restore or improve blood flow to the heart muscle.3,20 In Europe approximately two million AF patients, with co-existing coronary artery disease, are candidates for the procedure.3

Patients with AF 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.21,22 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 myocardial infarction and anticoagulation to reduce the risk of stroke. The combination of dual antiplatelet therapy and anticoagulation up to now is 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)

Clinical experience of Pradaxa® equates to over 7.9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than eight years and is approved in over 100 countries.23

Currently approved indications for Pradaxa® are: 24,25

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults

Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.26-28 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.28 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.26,28

Pradaxa® is the only non-vitamin K antagonist oral anticoagulant with an approved reversal agent. Praxbind® is approved in the European Union and United States for adult patients treated with Pradaxa® who require rapid reversal of its anticoagulant effects prior to urgent procedures/emergency surgery or in life threatening or uncontrolled bleeding.29,30

About Boehringer Ingelheim 

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 percent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. 

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

SOURCE: Boehringer Ingelheim