Clinical trial NCT04437303: Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
Official title: Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Stroke
Bleeding
Vascular Complications
Myocardial Infarction
Thrombosis Embolism
Keywords: Transcatheter Aortic Valve Implantation (TAVI)
Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Disease
Aortic Valve Stenosis
Stroke
Bleeding
Vascular Complications
Myocardial Infarction
Thrombosis Embolism
Heart Diseases
Oral Anticoagulation
Warfarin
Vitamin K Antagonist
Direct Acting Oral Anticoagulants
Protamine
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 Criteria:

* Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
* Uses oral anticoagulation at screening
* Provided written informed consent

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 atrial fibrillation

Primary outcomes:
measure: Net adverse clinical events
timeFrame: 30 days
Secondary outcomes:
measure: Procedure related primary endpoints
timeFrame: 30 days
measure: Procedure related bleeding complications
timeFrame: 30 days
measure: Procedure related thromboembolic complications
timeFrame: 30 days
measure: Thromboembolic complications
timeFrame: 30 days
measure: Neurologic events
timeFrame: 30 days
measure: Cerebrovascular events
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Bleeding complications
timeFrame: 30 days
measure: Early safety
timeFrame: 30 days
measure: Clinical efficacy
timeFrame: 30 days
measure: All-cause death
timeFrame: 30 days
measure: Cardiovascular death
timeFrame: 30 days
measure: Quality of Life
timeFrame: 30 days and 90 days
Other outcomes:
measure: New York Heart Association class for heart failure
timeFrame: 30 days
measure: Rehospitalisation
timeFrame: 30 days
measure: Permanent pacemaker implantation
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
Locations:
city: Aalst
country: Belgium
facility: A.S.Z. Hospital
city: Aalst
country: Belgium
facility: O.L.V. Hospital
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Genk
country: Belgium
facility: East Limburg Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Galway
country: Ireland
facility: University Hospital Galway
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Trieste
city: Luxembourg
country: Luxembourg
facility: National Institute of Cardiac Surgery and Interventional Cardiology
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: The Hague
country: Netherlands
facility: Haga Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: St. Antonius Hospital
name: Jurriën M ten Berg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: