What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI? (WOEST-3)
Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation, Atrial Flutter, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Oral Anticoagulant, NOAC - Novel Oral Anticoagulant, DOAC - Direct Oral Anticoagulant, DAPT - Dual Antiplatelet Therapy, Antithrombotic Therapy, Dual Therapy, Triple Therapy, Bleeding, Thrombosis, Stroke, Stent Thrombosis, Systemic Embolism, Percutaneous coronary intervention, Coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years
- Undergoing PCI (either ACS or elective PCI)
- History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC
Exclusion Criteria:
- Contra indication to edoxaban, aspirin or all P2Y12 inhibitors
- Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
- <12 months after any stroke
- CHADSVASc score ≥7
- Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
- Mechanical heart valve prosthesis
- Intracardiac thrombus or apical aneurysm requiring OAC
- Poor LV function (LVEF <30%) with proven slow-flow
- History of intracranial haemorrhage
- Active bleeding on randomization
- History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved
- Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.
- Known coagulopathy
- Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 109/L
- BMI >40 or bariatric surgery
- Kidney failure (eGFR <15)
- Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
- Active malignancy excluding non-melanoma skin cancer
- Life expectancy <1 year
- Pregnancy or breast-feeding women
Sites / Locations
- ASZ AalstRecruiting
- UZ AntwerpenRecruiting
- Imelda ZiekenhuisRecruiting
- UZ Brussel
- Ziekenhuis Oost-LimburgRecruiting
- AZ Maria Middelares GentRecruiting
- Jan Yperman
- AZ GroeningeRecruiting
- UZ LeuvenRecruiting
- AZ DeltaRecruiting
- Noordwest ZiekenhuisgroepRecruiting
- Amsterdam UMCRecruiting
- OLVGRecruiting
- HagaziekenhuisRecruiting
- Treant ZorggroepRecruiting
- Tergooi MCRecruiting
- St. Antonius HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
First month DAPT
Guideline-directed therapy
30-day DAPT (aspirin + P2Y12 inhibitor). After 30 days all patients will be treated with edoxaban and P2Y12 inhibitor. Selection of P2Y12 inhibitor is at the discretion of the treating physician, depending on both bleeding and ischemic risk. Dosage of aspirin and P2Y12 inhibitor is according to local guidelines. NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.
Standard guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients). After 30 days all patients will be treated with edoxaban and P2Y12 inhibitor. Selection of P2Y12 inhibitor is at the discretion of the treating physician, depending on both bleeding and ischemic risk. Dosage of aspirin and P2Y12 inhibitor is according to local guidelines. NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.