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Boehringer Ingelheim. (11/15/17). "Press Release: Key Sub-analyses of RE-DUAL PCI Showed Large Reductions in the Incidence of Bleeding Complications if Pradaxa (dabigatran etexilate) Dual Therapy Was Used Instead of Warfarin Triple Therapy". Ingelheim.

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 University of Uppsala
Products Product Pradaxa®
  Product 2 warfarin (INN)
Person Person Kreuzer, Jörg (Boehringer Ingelheim 201604 VP Medicine, Therapeutic Area Cardiovascular)
     


> Dual therapy with dabigatran consistently favourable across key sub-groups in atrial fibrillation patients following PCI with stent placement

> Benefits shown in sub-group analyses were consistent with overall results of the trial

> Data presented at AHA Scientific Sessions 2017 reinforce safety benefits of dabigatran


Boehringer Ingelheim has shared sub-analyses from the RE-DUAL PCI™ clinical trial at the AHA Scientific Sessions 2017 in Anaheim, California. RE-DUAL PCI™ investigated different treatment approaches in patients with non-valvular atrial fibrillation (AF) following percutaneous coronary intervention (PCI) with stent placement. Anticoagulation using dual therapy with dabigatran etexilate (marketed as Pradaxa®) and a single antiplatelet without aspirin was compared to triple therapy with warfarin. The new sub-analyses presented showed very consistent benefits of dual therapy with dabigatran across different pre-specified groups of patients, including:1

> Patients using different antiplatelet therapies (P2Y12 inhibitors ticagrelor or clopidogrel)
> Patients presenting with either acute coronary syndrome (ACS) or patients with no ACS
> Patients receiving a drug-eluting stent or a bare-metal stent

PCI with stenting is undertaken to improve the blood flow to the heart. It may be required in 20-30% of AF patients who already take an oral anticoagulant to reduce their risk of stroke.2 The current combination of potent antithrombotic therapies, which is triple therapy with warfarin and two antiplatelets, is associated with high rates of major bleeding.3-6 The main results of RE-DUAL PCI™7,8 were presented at this year’s ESC Congress and published in the New England Journal of Medicine. They showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran compared to triple therapy with warfarin. The rates of overall thromboembolic events were similar.

“When treating AF patients after PCI with stenting, it is important to understand how different clinical variables like if the patient had an acute coronary syndrome, the choice of stent type, or the choice of concomitant antiplatelet may influence the outcomes” explained Professor Jonas Oldgren, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. “The additional analyses of the RE-DUAL PCI trial, which we have presented at the AHA Scientific Sessions in Anaheim, showed that the results for dual therapy with dabigatran in these sub-groups are consistent with the overall results of the trial.”

The overall results for RE-DUAL PCI™ were:7,8

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

o 48% lower for dabigatran 110 mg dual therapy
o 28% lower for dabigatran 150 mg dual therapy (relative difference)

> Similar rates of overall thromboembolic events for both doses of dabigatran dual therapy compared to warfarin triple therapy, the key secondary endpoints


“We set out to answer the relevant questions physicians have when it comes to anticoagulation in patients with a stent,” commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “The sub-analyses from RE-DUAL PCI™ now reinforce the impressive results from the entire RE-DUAL population. Also in the sub-groups, a significantly better benefit-risk profile of dual therapy with dabigatran compared to triple therapy with warfarin was demonstrated.”


NOTES TO EDITORS


About RE-DUAL PCI™

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.7-9

RE-DUAL PCI™ 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.7

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.7-9

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.7-9


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.10 This intervention is conducted to restore or improve blood flow to the heart muscle.10,2 In Europe approximately two million AF patients with co-existing coronary artery disease are candidates for the procedure.2

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.11,12 Antithrombotic therapy is required to decrease a patient’s 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.13


Currently approved indications for Pradaxa® are: 14,15

> 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.16-18 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.18 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.16,18

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.19,20


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.


This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.


References

1. Oldgren J. et al. Subgroup analysis from the RE-DUAL PCI trial: Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation undergoing percutaneous coronary intervention. AHA Scientific Sessions 2017, Anaheim, California, Late-breaking session, Oral presentation on Nov 14, LBS.05.
2. Lip G. et al. Antithrombotic management of atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing coronary stenting: executive summary—a Consensus Document of the European Society of Cardiology Working Group on Thrombosis, endorsed by the European Heart Rhythm Association (EHRA) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). European Heart Journal. 2010;31:1311–18.
3. Coppens M. and Eikelboom JW. Antithrombotic Therapy After Coronary Artery Stenting in Patients With Atrial Fibrillation Circ Cardiovasc Interv. 2012;5:454–5.
4. Nikolsky E. et al. Outcomes of patients treated with triple antithrombotic therapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] trial). Am J Cardiol. 2012;109:831–838.
5. Andrade JG. et al. Risk of bleeding on triple antithrombotic therapy after percutaneous coronary intervention/ stenting: a systematic review and meta-analysis. Can J Cardiol. 2013; 29:204–212.
6. Verheugt FW. Triple antithrombotic therapy after coronary stenting in the elderly with atrial fibrillation: necessary or too hazardous? AmHeart J. 2012;163:531–534.
7. Cannon CP. et al. RE-DUAL PCI: Dual Antithrombotic Therapy with Dabigatran after Percutaneous Coronary Intervention in Patients with Atrial Fibrillation. ESC Congress, Barcelona, 2017, Abstract 1920.
8. Cannon CP. et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. New Engl J Med. 2017; DOI: [10.1056/NEJMoa1708454]. http://www.nejm.org/doi/full/10.1056/NEJMoa1708454. Last accessed November 2017.
9. Cannon CP. et al. Design and Rationale of the RE-DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting. Clin Cardiol. 2016;39(10):555-64. http://onlinelibrary.wiley.com/doi/10.1002/clc.22572/full. Last accessed November 2017.
10. Mayo Clinic. Coronary angioplasty and stents. http://www.mayoclinic.org/tests-procedures/angioplasty/basics/definition/prc-20014401. Last accessed November 2017.
11. Faxon DP. et al. Consensus Document: Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. Thromb Haemost. 2011;106:571–84.
12. Chan W. et al. Impact of Periprocedural Atrial Fibrillation on Short-Term Clinical Outcomes Following Percutaneous Coronary Intervention. American Journal of Cardiology. 2012; 109(4):471-77.
13. Boehringer Ingelheim Data on File.
14. Pradaxa® US Prescribing Information, 2015.
15. Pradaxa® European Summary of Product Characteristics, 2016.
16. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
17. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
18. Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.
19. Praxbind® European Summary of Product Characteristics, 2016.
20. Praxbind® US Prescribing Information, 2015.

   
Record changed: 2017-11-26

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