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Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial.
- Source :
-
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology [EuroIntervention] 2024 Jul 15; Vol. 20 (14), pp. e898-e904. Date of Electronic Publication: 2024 Jul 15. - Publication Year :
- 2024
-
Abstract
- The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y <subscript>12</subscript> inhibitor - preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y <subscript>12</subscript> inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y <subscript>12</subscript> inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y <subscript>12</subscript> inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban plus P2Y <subscript>12</subscript> inhibitor). With a sample size of 2,000 patients, this trial is powered to assess both superiority for major or clinically relevant non-major bleeding and non-inferiority for a composite of all-cause death, myocardial infarction, stroke, systemic embolism or stent thrombosis. In summary, the WOEST-3 trial is the first RCT temporarily omitting OAC in AF patients, comparing a 30-day DAPT strategy with guideline-directed therapy post-PCI to reduce bleeding events without hampering efficacy.
- Subjects :
- Aged
Female
Humans
Male
Middle Aged
Administration, Oral
Aspirin therapeutic use
Aspirin administration & dosage
Aspirin adverse effects
Dual Anti-Platelet Therapy methods
Purinergic P2Y Receptor Antagonists administration & dosage
Purinergic P2Y Receptor Antagonists adverse effects
Purinergic P2Y Receptor Antagonists therapeutic use
Treatment Outcome
Anticoagulants administration & dosage
Anticoagulants therapeutic use
Anticoagulants adverse effects
Atrial Fibrillation complications
Atrial Fibrillation drug therapy
Hemorrhage chemically induced
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention methods
Platelet Aggregation Inhibitors administration & dosage
Platelet Aggregation Inhibitors therapeutic use
Platelet Aggregation Inhibitors adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1969-6213
- Volume :
- 20
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 39007830
- Full Text :
- https://doi.org/10.4244/EIJ-D-24-00100