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.
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.
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.
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: email@example.com