Aortic Valve Disease, Aortic Valve Stenosis, Bleeding, Myocardial Infarction, Stroke, Thrombosis Embolism, Vascular Complications
Conditions
Keywords
Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Disease, Aortic Valve Stenosis, Stroke, Bleeding, Vascular Complications, Myocardial Infarction, Thrombosis Embolism, Heart Diseases, Oral Anticoagulation, Warfarin, Vitamin K Antagonist, Direct Acting Oral Anticoagulants, Protamine
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
Interventions
DRUGContinuation of oral anticoagulants
Oral anticoagulant treatment will not be interrupted before the procedure.
DRUGInterruption 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.
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| All-cause death | 30 days | — |
| Cardiovascular death | 30 days | — |
| 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 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 |
| 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 |
| 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 |
| 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 |
| Stroke | 30 days | All stroke as defined by the VARC-3 criteria |
| Bleeding complications | 30 days | Type 1-4 bleeding 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Permanent pacemaker implantation | 30 days | — |
| Bleeding | 30 days | As classified by Bleeding Academic Research Consortium (BARC) criteria |
| Rehospitalisation | 30 days | — |
| New York Heart Association class for heart failure | 30 days | — |
Countries
Belgium, Denmark, Ireland, Italy, Luxembourg, Netherlands
Outcome results
None listed