Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

Last updated: May 30, 2024
Sponsor: St. Antonius Hospital
Overall Status: Completed

Phase

4

Condition

Stroke

Vascular Diseases

Cerebral Ischemia

Treatment

Interruption of oral anticoagulants

Continuation of oral anticoagulants

Clinical Study ID

NCT04437303
NL73805.100.20
  • Ages > 18
  • All Genders

Study Summary

Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen.

Hypothesis:

Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Planned transfemoral or transsubclavian transcatheter aortic valve implantationprocedure

  • Uses oral anticoagulation at screening

  • Provided written informed consent

Exclusion

Exclusion Criteria:

Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:

  • Mechanical heart valve prosthesis

  • Intracardiac thrombus

  • < 3 months after venous thromboembolism

  • < 6 months after transient ischemic attack or stroke in patients with atrialfibrillation

Study Design

Total Participants: 858
Treatment Group(s): 2
Primary Treatment: Interruption of oral anticoagulants
Phase: 4
Study Start date:
November 25, 2020
Estimated Completion Date:
May 22, 2024

Connect with a study center

  • A.S.Z. Hospital

    Aalst,
    Belgium

    Site Not Available

  • O.L.V. Hospital

    Aalst,
    Belgium

    Site Not Available

  • ZNA Middelheim

    Antwerp,
    Belgium

    Site Not Available

  • AZ Sint-Jan

    Brugge,
    Belgium

    Site Not Available

  • East Limburg Hospital

    Genk,
    Belgium

    Site Not Available

  • University Hospital Leuven

    Leuven,
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Rigshospitalet Copenhagen

    Copenhagen,
    Denmark

    Site Not Available

  • University Hospital Galway

    Galway,
    Ireland

    Site Not Available

  • Azienda Sanitaria Universitaria Integrata di Trieste

    Trieste,
    Italy

    Site Not Available

  • National Institute of Cardiac Surgery and Interventional Cardiology

    Luxembourg,
    Luxembourg

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht 3435CM
    Netherlands

    Site Not Available

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Site Not Available

  • Amphia Hospital

    Breda,
    Netherlands

    Site Not Available

  • UMC Groningen

    Groningen,
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Haga Hospital

    The Hague,
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • Isala

    Zwolle,
    Netherlands

    Site Not Available

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