About this trial
The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy.
However, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest.
The WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years
Undergoing successful 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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
30-day DAPT
DrugDAPT (aspirin + P2Y12 inhibitor) during the first 30 days following PCI. After 30 days, all patients will be treated with edoxaban and a P2Y12 inhibitor.
Guideline-directed therapy
DrugGuideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)
Treatment groups
Trial outcomes
Primary outcomes
Primary safety endpoint
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
Primary efficacy endpoint
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
Secondary outcomes
Bleeding complications
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
Thrombotic complications
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
Net clinical benefit
Composite of major bleeding, myocardial infarction, stroke, systemic embolism all-cause death and stent thrombosis
Clinical symptom severity
CCS grade
Other outcomes
Quality of life as assessed by the EuroQol-5D-5L questionnaire
EuroQol-5D-5L questionnaire
Sponsors and contacts
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St. Antonius Hospital
Lead sponsor
Daiichi Sankyo
Collaborator