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Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI
Goethe Univ Frankfurt, Dept Cardiol, Theodor Stern Kai 7,Bldg 23A, D-60590 Frankfurt, Germany.
Hop Bichat Claude Bernard, FACT, Dept Hosp Univ, Paris, France;Univ Paris Diderot, Paris, France;INSERM, U1148, Paris, France;Hop Bichat Claude Bernard, AP HP, Paris, France.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.ORCID iD: 0000-0002-9969-3921
Univ Bonn, Med Klin & Poliklin 2, Bonn, Germany.
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2019 (English)In: JACC: Cardiovascular Interventions, ISSN 1936-8798, E-ISSN 1876-7605, Vol. 12, no 16, p. 1553-1561Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: The study sought to evaluate the effect of dabigatran dual therapy versus warfarin triple therapy across categories of renal function in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.

BACKGROUND: The RE-DUAL PCI (NCT02164864) trial of patients with atrial fibrillation undergoing percutaneous coronary intervention reported that dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) reduced the primary endpoint of major bleeding events (MBE) or clinically relevant nonmajor bleeding events (CRNMBE) compared with warfarin triple therapy, with noninferiority in overall thromboembolic events.

METHODS: Risk of a first MBE or CRNMBE and the composite of death or thromboembolic event (DTE) or unplanned revascularization were evaluated in 2,725 patients according to baseline creatinine clearance (CrCl) categories: 30 to <50, 50 to <80, and >= 80 ml/min.

RESULTS: Compared with warfarin, dabigatran 110 mg dual therapy reduced risk of MBE or CRNMBE across all categories of CrCl (p for interaction = 0.19). Dabigatran 150 mg dual therapy reduced risk of MBE or CRNMBE regardless of the CrCl category (p for interaction = 0.31). Risk of DTE or unplanned revascularization was similar to warfarin triple therapy for dabigatran 110 mg dual therapy across all CrCl categories. Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl >= 80 ml/min (p for interaction = 0.02).

CONCLUSIONS: In the RE-DUAL PCI trial, dabigatran dual therapy reduced bleeding events versus warfarin triple therapy irrespective of renal function, with overall similar risks of thromboembolic events but lower risks with dabigatran 150 mg in patients with normal CrCl. 

Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC , 2019. Vol. 12, no 16, p. 1553-1561
Keywords [en]
atrial fibrillation, dabigatran dual therapy, percutaneous coronary intervention, renal function, warfarin triple therapy
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-393724DOI: 10.1016/j.jcin.2019.05.050ISI: 000481654800007PubMedID: 31439336OAI: oai:DiVA.org:uu-393724DiVA, id: diva2:1355575
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AstraZenecaAvailable from: 2019-09-30 Created: 2019-09-30 Last updated: 2019-09-30Bibliographically approved

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