The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients current North American and European guidelines recommend a triple therapy strategy, including vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this triple therapy strategy is a significant increase in the risk of major bleeding. Furthermore, the ommitance of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K oral anticoagulants (NOAC), created numerous new antithrombotic treatment strategies for these patients with overlapping conditions. To date, evidence on the risks and benefits of these new antithrombotic treatment strategies is lacking. The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve prosthesis ánd undergoing coronary revascularisation through a better understanding of their demographics, antithrombotic management and related in-hospital and long-term outcomes. The WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment patterns and patient outcomes. Objective: To assess the different management patterns and related in-hospital and long-term safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12 inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation.
The WOEST 2 Registry is a prospective, international, multi-centre, non-interventional, cohort study designed to recruit an unselected cohort of patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation. Trial overview Name : WOEST 2 REGISTRY Target for enrollment : 2200 patients Time frame for inclusion : within 72 hours after index PCI or coronary artery bypass grafting (CABG) Follow-up : 24 months Visits : 30 days, 12 and 24 months after index PCI or CABG
Study Type
OBSERVATIONAL
Enrollment
2,200
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
ACTIVE_NOT_RECRUITINGUniversitair Ziekenhuis Antwerpen
Antwerp, Belgium
ACTIVE_NOT_RECRUITINGImelda Ziekenhuis
Bonheiden, Belgium
RECRUITINGZiekenhuis Oost-Limburg
Genk, Belgium
RECRUITINGUniversitair Ziekenhuis Leuven
Leuven, Belgium
ACTIVE_NOT_RECRUITINGOnze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
ACTIVE_NOT_RECRUITINGAmphia Ziekenhuis
Breda, Netherlands
ACTIVE_NOT_RECRUITINGSt. Antonius Hospital
Nieuwegein, Netherlands
RECRUITINGElizabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
ACTIVE_NOT_RECRUITINGComposite of the rate of non-fatal myocardial infarction, non-fatal ischemic stroke (including transient ischemic attack), non-central nervous system systemic embolization and cardiovascular death [the primary efficacy outcome].
Time frame: 1 year
The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome].
Bleeding will be classified by the Bleeding Academic Research Consortium (BARC) 2, 3, 4 and 5 bleeding criteria and by the Thrombolysis in Myocardial Infarction (TIMI) minor and major bleeding criteria.
Time frame: 1 year
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