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

NCT ID: NCT04437303

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 858 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2024-05-22

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

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Stroke; Bleeding; Vascular Complications; Myocardial Infarction; Thrombosis Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Continuation of oral anticoagulants

Group Type: ACTIVE_COMPARATOR

Continuation of oral anticoagulants

Intervention Type: DRUG

Oral anticoagulant treatment will not be interrupted before the procedure.

Interruption of oral anticoagulants

Group Type: ACTIVE_COMPARATOR

Interruption of oral anticoagulants

Intervention Type: DRUG

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.

Interventions

Continuation of oral anticoagulants

Oral anticoagulant treatment will not be interrupted before the procedure.

Intervention Type: DRUG

Interruption of oral anticoagulants

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jurriën M. ten Berg, MD, PhD

Professor dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jurriën M ten Berg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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, , 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, 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

Countries

Belgium; Denmark; Ireland; Italy; Luxembourg; Netherlands

References

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 Oct 23:e043448. doi: 10.1161/JAHA.125.043448. Online ahead of print.

Reference Type: DERIVED

PMID: 41128170 (View on PubMed)

van 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.

Reference Type: DERIVED

PMID: 39216096 (View on PubMed)

Other Identifiers

NL73805.100.20

Identifier Type: -

Identifier Source: org_study_id