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A prospective multicentre observational study on the management of patients on oral anticoagulation undergoing coronary artery stenting: rationale and design of the ongoing warfarin and coronary stenting (WAR-STENT) registry

Rubboli, Andrea; Bolognese, Leonardo; Di Pasquale, Giuseppe; Galvani, Marcello; La Vecchia, Luigi; Maggioni, Aldo P

Journal of Cardiovascular Medicine: February 2009 - Volume 10 - Issue 2 - p 200–203
doi: 10.2459/JCM.0b013e3283212f07
Research trial protocol
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Background The optimal management of patients on oral anticoagulation (OAC) undergoing coronary stenting (PCI-S) is currently undefined. Available evidence suggests that triple therapy of OAC, aspirin and clopidogrel is the most effective, though associated with a relevant incidence of major bleeding. Nearly all data, however, derive from small-size, retrospective studies in which the occurrence of bleeding has seldom been reported according to the ongoing therapy, and the relative contribution to overall bleeding of early haemorrhages has rarely been analysed separately. We design a prospective multicentre registry, which will include patients on OAC undergoing PCI-S.

Objective To prospectively evaluate the post-PCI-S antithrombotic treatment in patients on OAC, relative safety and efficacy of the various regimens, and periprocedural technical and pharmacological management.

Study design Sixty to seventy Italian centres will be enlisted. Patients on OAC at the time of PCI-S will be enrolled and followed up for 12 months. The primary endpoint will be the composite of major/minor bleeding, major adverse cardiac events (e.g., need for urgent re-revascularization, myocardial infarction, death) (MACE), arterial and/or venous thrombosis/thromboembolism. Secondary endpoints will be: major/minor bleeding, MACE, stent thrombosis, arterial or venous thromboembolic complications or both, and the need for blood transfusions.

Expected results and implications This multicentre, prospective registry of patients on OAC undergoing PCI-S will provide for the first time extensive and updated information on current clinical practice, and on the safety and efficacy of the various strategies. As a consequence, clues for the optimal management of this patient subset will be obtained.

aUnità Operativa di Cardiologia, Ospedale Maggiore, Bologna, Italy

bUnità Operativa di Cardiologia, Ospedale S. Donato, Arezzo, Italy

cUnità Operativa di Cardiologia, Ospedale G.B. Morgagni e Fondazione Cardiologica M. Z. Sacco, Forlì, Italy

dUnità Operativa di Cardiologia, Ospedale S. Bortolo, Vicenza, Italy

eCentro Studi ANMCO, Firenze, Italy

Received 5 November, 2008

Accepted 7 November, 2008

Correspondence to Andrea Rubboli, MD, FESC, Cardiac Catheterization Laboratory, Division of Cardiology, Ospedale Maggiore, Largo Nigrisoli 2, 40133 Bologna, Italy Tel: +39 0 516 478976; fax: +39 0 516 478635; e-mail: andrearubboli@libero.it

© 2009 Italian Federation of Cardiology. All rights reserved.