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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2024
  • participants needed
    858
  • sponsor
    St. Antonius Hospital
Updated on 24 March 2022
stenosis
stroke
anticoagulants
myocardial infarction
infarct
fibrillation
vitamin k
aortic valve stenosis
transcatheter aortic valve implantation
tavi
dabigatran
anticoagulation therapy

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

Details
Condition Aortic Valve Disease, Aortic Valve Stenosis, Stroke, Bleeding, Vascular Complications, Myocardial Infarction, Thrombosis Embolism
Treatment Continuation of oral anticoagulants, Interruption of oral anticoagulants
Clinical Study IdentifierNCT04437303
SponsorSt. Antonius Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Planned transfemoral transcatheter aortic valve implantation procedure
Uses oral anticoagulation at screening

Exclusion Criteria

Patients at high risk for thromboembolism for who 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 atrial
fibrillation
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