Bode, Christoph

Cohen, Marc

Fox, Keith

Gibson, C. Michael

Halperin, Johnathan

Husted, Steen

Lip, Gregory Y.h.

Mehran, Roxana

Peterson, Eric

Van Eickels, Martin

Verheugt, Freek

Wildgoose, Peter

American Heart Journal

C. Michael Gibson

Roxana Mehran

Christoph Bode

Johnathan Halperin

Freek Verheugt

Peter Wildgoose

Martin van Eickels

Gregory Y.H. Lip

Marc Cohen

Steen Husted

Eric Peterson

Keith Fox

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An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI)

Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes.DesignPIONEER AF-PCI (ClinicalTrials.gov NCT01830543) is an exploratory, open-label, randomized, multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist (VKA) treatment strategy in subjects who have paroxysmal, persistent, or permanent nonvalvular AF and have undergone PCI with stent placement. Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months (a WOEST trial–like strategy), or rivaroxaban 2.5 mg twice daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, an ATLAS trial–like strategy), or dose-adjusted VKA once daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, traditional triple therapy). All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding, bleeding requiring medical attention, and minor bleeding (collectively, clinically significant bleeding).ConclusionThe PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications

University of Birmingham Research Portal

English

Halperin, Jonathan L.

Verheugt, Freek W. A.

Eickels, Martin van

Lip, Gregory Y. H.

Peterson, Eric D.

Fox, Keith A. A.

FreiDok plus

http://pure-oai.bham.ac.uk/ws/files/18362139/Gibson_et_al_OPen_label_randomized_controlled_multicenter_study_AHJ_2014.pdf

An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI)

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University of Birmingham Research Portal

University of Birmingham Research Portal

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