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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437303
• Other study ID #: NL73805.100.20
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2020
• Est. completion date: May 22, 2024

Study information

• Verified date: May 2024
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 858
• Est. completion date: May 22, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Continuation of oral anticoagulants
Oral anticoagulant treatment will not be interrupted before the procedure.
• 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.

Locations

Country	Name	City	State
Belgium	A.S.Z. Hospital	Aalst
Belgium	O.L.V. Hospital	Aalst
Belgium	ZNA Middelheim	Antwerp
Belgium	AZ Sint-Jan	Brugge
Belgium	East Limburg Hospital	Genk
Belgium	University Hospital Leuven	Leuven
Belgium	AZ Delta	Roeselare
Denmark	Rigshospitalet Copenhagen	Copenhagen
Ireland	University Hospital Galway	Galway
Italy	Azienda Sanitaria Universitaria Integrata di Trieste	Trieste
Luxembourg	National Institute of Cardiac Surgery and Interventional Cardiology	Luxembourg
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	UMC Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht UMC+	Maastricht
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Netherlands	Radboud UMC	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Haga Hospital	The Hague
Netherlands	UMC Utrecht	Utrecht
Netherlands	Isala	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Countries where clinical trial is conducted

Belgium,  Denmark,  Ireland,  Italy,  Luxembourg,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New York Heart Association class for heart failure		30 days
Other	Rehospitalisation		30 days
Other	Permanent pacemaker implantation		30 days
Other	Bleeding	As classified by Bleeding Academic Research Consortium (BARC) criteria	30 days
Primary	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	Procedure related primary endpoints	Cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee	30 days
Secondary	Procedure related bleeding complications	Type 1-4 bleeding as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee	30 days
Secondary	Procedure related thromboembolic complications	All stroke (except haemorrhagic), TIA, myocardial infarction, systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source) as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee	30 days
Secondary	Thromboembolic complications	All stroke (except haemorrhagic), TIA, myocardial infarction and systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source) as defined by the VARC-3 criteria	30 days
Secondary	Neurologic events	Overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury as defined by the VARC-3 criteria	30 days
Secondary	Cerebrovascular events	All stroke and TIA as defined by the VARC-3 criteria.	30 days
Secondary	Stroke	All stroke as defined by the VARC-3 criteria	30 days
Secondary	Bleeding complications	Type 1-4 bleeding as defined by the VARC-3 criteria	30 days
Secondary	Early safety	Freedom from all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device as defined by the VARC-3 criteria	30 days
Secondary	Clinical efficacy	Freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline of >10 point as defined by the VARC-3 criteria	30 days
Secondary	All-cause death		30 days
Secondary	Cardiovascular death		30 days
Secondary	Quality of Life	Assessed by Short Form(SF)-12, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Toronto aortic stenosis quality of life questionnaire (TASQ)	30 days and 90 days