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

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

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• 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):
  • 48% lower for dabigatran 110 mg dual therapy
  • 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.”

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/RE-DUAL-PCI-sub-analysis-data-presented-at-AHA-2017

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Boehringer Ingelheim GmbH
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Friederike Middeke
Phone: +49 6132 – 77 141575
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