Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
1 other identifier
interventional
858
6 countries
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2020
Longer than P75 for phase_4
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2024
CompletedMay 31, 2024
May 1, 2024
3.3 years
May 19, 2020
May 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Net adverse clinical events
A composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications at 30 days post TAVI as defined by the VARC-3 criteria
30 days
Secondary Outcomes (13)
Procedure related primary endpoints
30 days
Procedure related bleeding complications
30 days
Procedure related thromboembolic complications
30 days
Thromboembolic complications
30 days
Neurologic events
30 days
- +8 more secondary outcomes
Other Outcomes (4)
New York Heart Association class for heart failure
30 days
Rehospitalisation
30 days
Permanent pacemaker implantation
30 days
- +1 more other outcomes
Study Arms (2)
Continuation of oral anticoagulants
ACTIVE COMPARATORInterruption of oral anticoagulants
ACTIVE COMPARATORInterventions
Oral anticoagulant treatment will not be interrupted before the procedure.
Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy. * For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m\^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m\^2 96 hours before procedure. * For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol. * After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician.
Eligibility Criteria
You may qualify if:
- Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
- Uses oral anticoagulation at screening
- Provided written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
A.S.Z. Hospital
Aalst, Belgium
O.L.V. Hospital
Aalst, Belgium
ZNA Middelheim
Antwerp, Belgium
AZ Sint-Jan
Bruges, Belgium
East Limburg Hospital
Genk, Belgium
University Hospital Leuven
Leuven, Belgium
AZ Delta
Roeselare, 8800, Belgium
Rigshospitalet Copenhagen
Copenhagen, Denmark
University Hospital Galway
Galway, Ireland
Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, Italy
National Institute of Cardiac Surgery and Interventional Cardiology
Luxembourg, Luxembourg
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435CM, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
UMC Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht UMC+
Maastricht, Netherlands
Radboud UMC
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Haga Hospital
The Hague, Netherlands
UMC Utrecht
Utrecht, Netherlands
Isala
Zwolle, Netherlands
Related Publications (2)
van Bergeijk KH, Overduin DC, Venema CS, van Ginkel DJ, van der Werf HW, van den Heuvel AFM, Voors AA, Wykrzykowska JJ, Ten Berg JM. Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis. J Am Heart Assoc. 2025 Nov 4;14(21):e043448. doi: 10.1161/JAHA.125.043448. Epub 2025 Oct 23.
PMID: 41128170DERIVEDvan Ginkel DJ, Bor WL, Aarts HM, Dubois C, De Backer O, Rooijakkers MJP, Rosseel L, Veenstra L, van der Kley F, van Bergeijk KH, Van Mieghem NM, Agostoni P, Voskuil M, Schotborgh CE, IJsselmuiden AJJ, Van Der Heyden JAS, Hermanides RS, Barbato E, Mylotte D, Fabris E, Frambach P, Dujardin K, Ferdinande B, Peper J, Rensing BJWM, Timmers L, Swaans MJ, Brouwer J, Nijenhuis VJ, Overduin DC, Adriaenssens T, Kobari Y, Vriesendorp PA, Montero-Cabezas JM, El Jattari H, Halim J, Van den Branden BJL, Leonora R, Vanderheyden M, Lauterbach M, Wykrzykowska JJ, van 't Hof AWJ, van Royen N, Tijssen JGP, Delewi R, Ten Berg JM; POPular PAUSE TAVI Investigators.; POPular PAUSE TAVI Investigators. Continuation versus Interruption of Oral Anticoagulation during TAVI. N Engl J Med. 2025 Jan 30;392(5):438-449. doi: 10.1056/NEJMoa2407794. Epub 2024 Aug 31.
PMID: 39216096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jurriën M ten Berg, MD PhD
St. Antonius Hospital
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
May 19, 2020
First Posted
June 18, 2020
Study Start
November 25, 2020
Primary Completion
March 21, 2024
Study Completion
May 22, 2024
Last Updated
May 31, 2024
Record last verified: 2024-05