Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days.
ID
Bron
Verkorte titel
Aandoening
Aortic Valve Stenosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A composite of cardiovascular mortality, stroke, myocardial infarction, major vascular complications and major, disabling and life-threatening bleeding complications at 30 days post TAVI as defined by the Valve Academic Research Consortium(VARC)-2 criteria.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days.
Onderzoeksopzet
Hospital discharge, 30 days, 3 months
Onderzoeksproduct en/of interventie
Uninterrupted periprocedrual oral anticoagulant treatment
Publiek
Dirk-Jan van Ginkel
+31 (0)88 320 6648
d.van.ginkel@antoniusziekenhuis.nl
Wetenschappelijk
Dirk-Jan van Ginkel
+31 (0)88 320 6648
d.van.ginkel@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Planned transfemoral transcatheter aortic valve implantation procedure
- Established indication for oral anticoagulation
- Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients at high risk for thromboembolism for who interruption of oral anticoagulants is no option:
- Mechanical heart valve prosthesis
- Intracardiac thrombus
< 3 months after venous thromboembolism
< 6 months after transient ischemic attack or stroke in patients with atrial fibrillation
Opzet
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