What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?
WOEST-3
2 other identifiers
interventional
2,000
2 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2023
Longer than P75 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
January 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 15, 2023
December 1, 2023
4.7 years
June 16, 2020
December 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary safety endpoint
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
6 weeks
Primary efficacy endpoint
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
6 weeks
Secondary Outcomes (11)
Bleeding complications
6 months
Thrombotic complications
6 months
Net clinical benefit
6 weeks, 3 months, 6 months
Clinical symptom severity
6 weeks, 3 months, 6 months
All-cause death
6 weeks, 3 months, 6 months
- +6 more secondary outcomes
Other Outcomes (1)
Quality of life as assessed by the EuroQol-5D-5L questionnaire
6 weeks, 3 months, 6 months
Study Arms (2)
First month DAPT
ACTIVE COMPARATOR30-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.
Guideline-directed therapy
ACTIVE COMPARATORStandard 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Antonius Hospitallead
- Daiichi Sankyocollaborator
Study Sites (20)
ASZ Aalst
Aalst, Belgium
UZ Antwerpen
Antwerp, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
UZ Brussel
Brussels, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
AZ Maria Middelares Gent
Ghent, Belgium
Jan Yperman
Ieper, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
AZ Delta
Roeselare, Belgium
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Treant Zorggroep
Emmen, Netherlands
Zuyderland Ziekenhuis
Heerlen, Netherlands
Tergooi MC
Hilversum, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Hagaziekenhuis
The Hague, Netherlands
Elisabeth Tweesteden Ziekenhuis
Tilburg, Netherlands
Related Publications (1)
Verburg A, Bor WL, Kucuk IT, Henriques JPS, Vink MA, Ruifrok WT, Plomp J, Heestermans TACM, Schotborgh CE, Vlaar PJ, Magro M, Rikken SAOF, van den Broek WWA, van Mieghem CAG, Cornelis K, Rosseel L, Dujardin KS, Vandeloo B, Vandendriessche T, Ferdinande B, van 't Hof AWJ, Tijssen JGP, Limbruno U, De Caterina R, Rubboli A, Angiolillo DJ, Adriaenssens T, Dewilde W, Ten Berg JM. Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial. EuroIntervention. 2024 Jul 15;20(14):e898-e904. doi: 10.4244/EIJ-D-24-00100.
PMID: 39007830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jurriën M ten Berg, Prof, MD
St. Antonius Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor dr.
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 18, 2020
Study Start
January 11, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
December 15, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Within 1 year following article publication. End date to be determined.
- Access Criteria
- Researchers who provide a methodologically sound proposal.
Will individual participant data be available? Yes What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). What other documents will be available? Study Protocol, informed consent form, clinical study report When will data be available (start and end dates)? Within 1 year following article publication. End date to be determined. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? To achieve aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to as.verburg@antoniusziekenhuis.nl. To gain access, data requestors will need to sign a data access agreement.