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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
858
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.
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
...and 12 more locations
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
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
Neurologic events
Overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury as defined by the VARC-3 criteria
Time frame: 30 days
Cerebrovascular events
All stroke and TIA as defined by the VARC-3 criteria.
Time frame: 30 days
Stroke
All stroke as defined by the VARC-3 criteria
Time frame: 30 days
Bleeding complications
Type 1-4 bleeding as defined by the VARC-3 criteria
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
All-cause death
Time frame: 30 days
Cardiovascular death
Time frame: 30 days
Quality of Life
Assessed by Short Form(SF)-12, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Toronto aortic stenosis quality of life questionnaire (TASQ)
Time frame: 30 days and 90 days
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