Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
- Conditions
- Thrombosis EmbolismBleedingAortic Valve DiseaseMyocardial InfarctionAortic Valve StenosisStrokeVascular Complications
- Interventions
- Drug: Continuation of oral anticoagulantsDrug: Interruption of oral anticoagulants
- Registration Number
- NCT04437303
- Lead Sponsor
- St. Antonius Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 858
- Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
- Uses oral anticoagulation at screening
- Provided written informed consent
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuation of oral anticoagulants Continuation of oral anticoagulants - Interruption of oral anticoagulants Interruption of oral anticoagulants -
- Primary Outcome Measures
Name Time Method Net adverse clinical events 30 days 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
- Secondary Outcome Measures
Name Time Method Procedure related thromboembolic complications 30 days 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
All-cause death 30 days Bleeding complications 30 days Type 1-4 bleeding as defined by the VARC-3 criteria
Cerebrovascular events 30 days All stroke and TIA as defined by the VARC-3 criteria.
Clinical efficacy 30 days 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
Stroke 30 days All stroke as defined by the VARC-3 criteria
Early safety 30 days 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
Quality of Life 30 days and 90 days Assessed by Short Form(SF)-12, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Toronto aortic stenosis quality of life questionnaire (TASQ)
Procedure related primary endpoints 30 days 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
Procedure related bleeding complications 30 days Type 1-4 bleeding as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee
Thromboembolic complications 30 days 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
Neurologic events 30 days Overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury as defined by the VARC-3 criteria
Cardiovascular death 30 days
Trial Locations
- Locations (22)
AZ Delta
🇧🇪Roeselare, Belgium
Leiden University Medical Center
🇳🇱Leiden, Netherlands
A.S.Z. Hospital
🇧🇪Aalst, Belgium
Radboud UMC
🇳🇱Nijmegen, Netherlands
Haga Hospital
🇳🇱The Hague, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Utrecht, Netherlands
O.L.V. Hospital
🇧🇪Aalst, Belgium
ZNA Middelheim
🇧🇪Antwerp, Belgium
East Limburg Hospital
🇧🇪Genk, Belgium
University Hospital Leuven
🇧🇪Leuven, Belgium
National Institute of Cardiac Surgery and Interventional Cardiology
🇱🇺Luxembourg, Luxembourg
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
AZ Sint-Jan
🇧🇪Brugge, Belgium
Erasmus MC
🇳🇱Rotterdam, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Maastricht UMC+
🇳🇱Maastricht, Netherlands
Isala
🇳🇱Zwolle, Netherlands
Rigshospitalet Copenhagen
🇩🇰Copenhagen, Denmark
University Hospital Galway
🇮🇪Galway, Ireland
Azienda Sanitaria Universitaria Integrata di Trieste
🇮🇹Trieste, Italy