What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?

Last updated: December 14, 2023
Sponsor: St. Antonius Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Myocardial Ischemia

Thrombosis

Stroke

Treatment

30-day DAPT

Guideline-directed therapy

Clinical Study ID

NCT04436978
NL81102.100.22
2022-001298-30
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥ 18 years
  2. Undergoing successful PCI (either ACS or elective PCI)
  3. History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutterwith a long-term (≥ 1 year) indication for OAC

Exclusion

Exclusion Criteria:

  1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors
  2. Current indication for OAC besides atrial fibrillation/flutter (e.g. venousthromboembolism)
  3. <12 months after any stroke
  4. CHADSVASc score ≥7
  5. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
  6. Mechanical heart valve prosthesis
  7. Intracardiac thrombus or apical aneurysm requiring OAC
  8. Poor LV function (LVEF <30%) with proven slow-flow
  9. History of intracranial haemorrhage
  10. Active bleeding on randomization
  11. History of intraocular, spinal, retroperitoneal, or traumatic intra-articularbleeding, unless the causative factor has been permanently resolved
  12. Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has beenpermanently resolved.
  13. Known coagulopathy
  14. Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 109/L
  15. BMI >40 or bariatric surgery
  16. Kidney failure (eGFR <15)
  17. Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
  18. Active malignancy excluding non-melanoma skin cancer
  19. Life expectancy <1 year
  20. Pregnancy or breast-feeding women

Study Design

Total Participants: 2000
Treatment Group(s): 2
Primary Treatment: 30-day DAPT
Phase: 4
Study Start date:
January 11, 2023
Estimated Completion Date:
December 01, 2027

Connect with a study center

  • ASZ Aalst

    Aalst,
    Belgium

    Active - Recruiting

  • UZ Antwerpen

    Antwerpen,
    Belgium

    Active - Recruiting

  • Imelda Ziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel,
    Belgium

    Active - Recruiting

  • Ziekenhuis Oost-Limburg

    Genk,
    Belgium

    Active - Recruiting

  • AZ Maria Middelares Gent

    Gent,
    Belgium

    Active - Recruiting

  • Jan Yperman

    Ieper,
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare,
    Belgium

    Active - Recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • OLVG

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Hagaziekenhuis

    Den Haag,
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Treant Zorggroep

    Emmen,
    Netherlands

    Active - Recruiting

  • Zuyderland Ziekenhuis

    Heerlen,
    Netherlands

    Site Not Available

  • Tergooi MC

    Hilversum,
    Netherlands

    Active - Recruiting

  • St. Antonius Hospital

    Nieuwegein,
    Netherlands

    Active - Recruiting

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg,
    Netherlands

    Active - Recruiting

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