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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,000
DAPT (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 (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)
ASZ Aalst
Aalst, Belgium
RECRUITINGUZ Antwerpen
Antwerp, Belgium
RECRUITINGImelda Ziekenhuis
Bonheiden, Belgium
RECRUITINGUZ Brussel
Brussels, Belgium
RECRUITINGZiekenhuis Oost-Limburg
Genk, Belgium
RECRUITINGAZ Maria Middelares Gent
Ghent, Belgium
RECRUITINGJan Yperman
Ieper, Belgium
NOT_YET_RECRUITINGAZ Groeninge
Kortrijk, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGAZ Delta
Roeselare, Belgium
RECRUITING...and 10 more locations
Primary safety endpoint
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
Time frame: 6 weeks
Primary efficacy endpoint
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
Time frame: 6 weeks
Bleeding complications
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
Time frame: 6 months
Thrombotic complications
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
Time frame: 6 months
Net clinical benefit
Composite of major bleeding, myocardial infarction, stroke, systemic embolism all-cause death and stent thrombosis
Time frame: 6 weeks, 3 months, 6 months
Clinical symptom severity
CCS grade
Time frame: 6 weeks, 3 months, 6 months
All-cause death
All-cause death as defined by ARC-2 and SCTI
Time frame: 6 weeks, 3 months, 6 months
Myocardial infarction
Myocardial infarction as defined by the 4th Universal Definition of Myocardial Infarction
Time frame: 6 weeks, 3 months, 6 months
Stroke
Stroke as defined by VARC-2 definitions
Time frame: 6 weeks, 3 months, 6 months
Systemic embolism
Systemic embolism according to ENTRUST-AF PCI definition
Time frame: 6 weeks, 3 months, 6 months
Stent thrombosis
Stent thrombosis as defined by ARC-2
Time frame: 6 weeks, 3 months, 6 months
Major bleeding
Major bleeding as defined by BARC 3 or 5
Time frame: 6 weeks, 3 months, 6 months
Clinically relevant non-major bleeding
CRNM as defined by BARC 2
Time frame: 6 weeks, 3 months, 6 months
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