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Relationship of stroke and bleeding risk profiles to efficacy and safety of dabigatran dual therapy versus warfarin triple therapy in atrial fibrillation after percutaneous coronary intervention: An ancillary analysis from the RE-DUAL PCI trial
Univ Liverpool, Liverpool Ctr Cardiovasc Sci, Liverpool L69 3BX, Merseyside, England;Liverpool Heart & Chest Hosp, Liverpool L69 3BX, Merseyside, England;Aalborg Univ, Dept Clin Med, Aalborg Thrombosis Res Unit, Aalborg, Denmark.
Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA.
Sorbonne Univ Paris VI, Pitie Salpetriere Hosp, ACT Study Grp, Paris, France.
St Bartholomews Hosp, London, England.
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2019 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 212, p. 13-22Article in journal (Refereed) Published
Abstract [en]

Background In the RE-DUAL PCI trial of patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI), dabigatran dual therapy (110 or 150 mg bid, plus clopidogrel or ticagrelor) reduced International Society on Thrombosis and Haemostasis bleeding events compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. This analysis assessed outcomes in relation to patient bleeding and stroke risk profiles, based on the modified HAS-BLED and CHA(2)DS(2)-VASc scores. Methods The primary endpoint, major bleeding event (MBE) or clinically relevant nonmajor bleeding event (CRNMBE), was compared across study arms in patients categorized by modified HAS-BLED score 0-2 or >= 3. The composite endpoint of death, thromboembolic event, and unplanned revascularization rates was compared in patients categorized by CHA(2)DS(2)-VASc score 0-1, 2, or >= 3. Results Risk of MBE or CRNMBE was lower with dabigatran dual therapy (both doses) versus warfarin triple therapy, irrespective of modified HAS-BLED category (treatment-by-subgroup interaction P-value 0.584 and 0.273 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Risk of the composite thromboembolic endpoint was similar across CHA(2)DS(2)-VASc categories and consistent with overall study results (interaction P-value 0.739 and 0.075 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Higher HAS-BLED scores were associated with higher risks of bleeding in AF patients after PCI in a treatment-independent analysis. Conclusion Dabigatran dual therapy reduced bleeding events irrespective of bleeding risk category and demonstrated similar efficacy regardless of stroke risk category when compared with warfarin triple therapy.

Place, publisher, year, edition, pages
MOSBY-ELSEVIER , 2019. Vol. 212, p. 13-22
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Cardiac and Cardiovascular Systems
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URN: urn:nbn:se:uu:diva-385963DOI: 10.1016/j.ahj.2019.02.006ISI: 000468402300002PubMedID: 30928824OAI: oai:DiVA.org:uu-385963DiVA, id: diva2:1327513
Available from: 2019-06-19 Created: 2019-06-19 Last updated: 2019-06-19Bibliographically approved

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