NCT04437303

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 858 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DRUG	Continuation of oral anticoagulants	Oral anticoagulant treatment will not be interrupted before the procedure.
DRUG	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.

Timeline

• Start date: 2020-11-25
• Primary completion: 2024-03-21
• Completion: 2024-05-22
• First posted: 2020-06-18
• Last updated: 2024-05-31

Locations

22 sites across 6 countries: Belgium, Denmark, Ireland, Italy, Luxembourg, Netherlands