Design and rationale of the RE-DUAL PCI trial

• Verfasst von: Cannon, Christopher P. [VerfasserIn]
• Verfasst von: Kreuzer, Jörg [VerfasserIn]
• Verfasst von: Brückmann, Martina [VerfasserIn]
• Titel: Design and rationale of the RE-DUAL PCI trial
• Titelzusatz: 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
• Verf.angabe: Christopher P. Cannon MD, Savion Gropper MD, PhD, Deepak L. Bhatt MD, MPH, Stephen G. Ellis MD, Takeshi Kimura MD, Gregory Y.H. Lip MD, Ph. Gabriel Steg MD, Jurriën M. ten Berg MD, Jenny Manassie BMedSc, Jörg Kreuzer MD, Jon Blatchford CStat, Joseph M. Massaro PhD, Martina Brueckmann MD, Ernesto Ferreiros Ripoll MD, Jonas Oldgren MD, PhD, Stefan H. Hohnloser MD, on behalf of the RE-DUAL PCI Steering Committee and Investigators
• E-Jahr: 2016
• Jahr: 26 August 2016
• Umfang: 10 S.
• Fussnoten: Gesehen am 02.07.2019
• Titel Quelle: Enthalten in: Clinical cardiology
• Ort Quelle: Weinheim [u.a.] : Wiley, 1978
• Jahr Quelle: 2016
• Band/Heft Quelle: 39(2016), 10, Seite 555-564
• ISSN Quelle: 1932-8737
• DOI: doi:10.1002/clc.22572
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Anti platelet therapy
• Sach-SW: Arrhythmia/all
• Sach-SW: Cardiac
• Sach-SW: catheterization/diagnostic interventional
• Sach-SW: Clinical trials
• Sach-SW: General clinical cardiology
• Sach-SW: management
• Sach-SW: Pharmacology
• Sach-SW: Stroke prevention
• Sach-SW: Thrombosis/hypercoagulable states
• K10plus-PPN: 1668366789

Abstract

Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest-sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. The RE-DUAL PCI trial (NCT 02164864) is a phase 3b, a strategy of prospective, randomized, open-label, blinded-endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibitor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a P2Y12 inhibitor (either clopidogrel or ticagrelor, and low-dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular AF patients who have undergone percutaneous coronary intervention with stenting. The primary endpoint is time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding event. Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize ∼ 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population.