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.
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.


METHODS
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.
Rubboli
Andrea
A
Unità Operativa di Cardiologia, Ospedale Maggiore, Bologna, Italy. andrearubboli@libero.it
Bolognese
Leonardo
L
Di Pasquale
Giuseppe
G
Galvani
Marcello
M
La Vecchia
Luigi
L
Maggioni
Aldo P
AP
D000284:Administration, Oral; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000628:therapy*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007558:Italy; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D018570:Risk Assessment; D015607:Stents; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
D000925:Anticoagulants; D014859:Warfarin