Acute Coronary Syndromes, Atrial Fibrillations, Bleeding, Coronary Artery Diseases, Heart Valve Prostheses, Myocardial Infarction, Stroke
Conditions
Keywords
Atrial Fibrillations, Heart Valve Prostheses, Acute Coronary Syndromes, Percutaneous Coronary Revascularization, Coronary Artery Bypass Grafting, Coronary Artery Diseases, Myocardial Infarction, Ischemic stroke, Bleeding, Thrombosis, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Embolism and Thrombosis, Platelet Aggregation Inhibitors, Aspirin, Clopidogrel, Ticagrelor, Prasugrel, Antithrombotic treatment, Oral anticoagulation, Warfarin, Dabigatran etexilate mesylate, Apixaban, Rivaroxaban, Direct Factor Xa Inhibitors, Direct Thrombin Inhibitors
Brief summary
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.
Detailed description
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
Interventions
DRUGCombination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
Sponsors
St. Antonius Hospital
R&D Cardiologie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria: 1. Patient is ≥ 18 years of age; 2. Patients with a diagnosis of atrial fibrillation (prior to hospitalisation ór during hospitalisation within 72h after coronary revascularisation) and/or with a heart valve prosthesis (aortic/mitral); 3. Chronic treatment with OAC or NOAC therapy at inclusion or the intention to start chronic treatment with OAC or NOAC within 72h after coronary revascularisation AND with intended duration of treatment for at least one year after inclusion in the registry; 4. Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent); 5. Prescription of a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel) because of CABG following acute coronary syndrome\* and /or because of PCI (with deployment of at least 1 coronary stent). 6. Patient has provided written informed consent.
Exclusion criteria
A potential subject who meets ANY of the following criteria will be excluded from participation in this study: 1. Patients unable to sign informed consent (including mental disabled patients); 2. Patients with life expectancy \< 1 year; 3. Allergy or intolerance to P2Y12 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite 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]. | 1 year | — |
| The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome]. | 1 year | 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. |
Countries
Belgium, Netherlands
Contacts
Primary ContactWilbert Bor, MD
Outcome results
None listed