Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
A single-center, investigator-initiated, single arm interventional study in patients
 undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical
 Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal
 indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement
 for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after
 three months of edoxaban treatment.
Rationale: Thromboembolic- and bleeding events can occur after TAVI and can have great
 consequences. There is currently no evidence-based guideline on prevention of thromboembolic
 events after TAVI and the current standard of care with DAPT 3-6 months is based on expert
 opinion. Recently multislice computed tomography (MSCT) studies identified bioprosthesis
 leaflet thickening and impaired leaflet motion after TAVI. The goal of this study is to
 investigate whether in TAVI patients, treatment with edoxaban leads to a reduction in leaflet
 thickening incidence after 3 months and whether it is safe and clinically efficient.

 Objective: To investigate whether treatment with edoxaban leads to a decrease in incidence of
 leaflet thickening and is clinical efficient and safe.

 Study design: A single-center, investigator-initiated, open-label, observational study.

 Study population: Patients undergoing transfemoral transcatheter aortic valve replacement in
 the Erasmus University Medical Center with no formal novel oral
 anticoagulants/vitamin-K-antagonist (NOAC/VKA) indication.

 Intervention (if applicable): Patients will be treated with edoxaban for a period of 3 months
 following TAVI. Afterwards they will switch to acetylsalicylic acid.

 Main study parameters/endpoints: The incidence of leaflet thickening on MSCT 3 months after
 TAVI and edoxaban treatment.

 Nature and extent of the burden and risks associated with participation, benefit and group
 relatedness: Thus far edoxaban has proven to be safe and non-inferior to treatment with
 warfarin in several indications. The role of anticoagulant agents in TAVI still has to be
 unravelled. Subjects participating in this trial are possibly at higher risk for bleeding
 complications than patients being treated with dual antiplatelet therapy after TAVI.
Inclusion Criteria:

 -  Completed successful elective TAVI for severe native aortic valve stenosis with any
 commercially-available transcatheter heart valve (THV).

 -  Correct positioning of a single prosthetic heart valve

 -  Device success, defined by:

 -  Mean aortic valve gradient < 20 mmHg

 -  Peak transvalvular velocity < 3.0 m/s

 -  Aortic valve regurgitation of 2 or less

 -  No periprocedural complications.

 -  No overt stroke

 -  No uncontrolled bleeding

 -  No major vascular complication defined by the Valve academic research committee 2
 (VARC-2) consensus

 -  No formal indication for oral anticoagulation

 -  Prevention of thromboembolic complications in patients with atrial fibrillation

 -  Prevention for recurrent venous thromboembolism

 -  Prevention for recurrent pulmonary embolism

 Exclusion Criteria:

 -  History of life-threatening or major bleeding event ≥ Bleeding academic research
 committee (BARC) 3b definitions within the last year.

 -  Conditions with a high risk of bleeding

 -  Active peptic ulcer or upper gastrointestinal bleeding (< 3 months)

 -  Malignancy with high risk of bleeding

 -  Recent unresolved brain of spinal injury

 -  Spinal or ophthalmic surgery within last 3 months prior to enrolment

 -  Intracranial haemorrhage

 -  Esophagal varices

 -  Arteriovenous malformations with high risk of bleeding

 -  Vascular aneurysms

 -  Major intraspinal or intracerebral vascular abnormalities

 -  Hypersensitivity or contraindications to edoxaban

 -  No percutaneous coronary intervention within 6 months prior to randomization
 (requiring DAPT after TAVR)

 -  Dialysis-dependency or glomerular filtration rate < 30 mL/min at time of enrollment

 -  Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <
 50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease

 -  Patients unable to adhere to or complete the investigational protocol for any reason
 including but not limited to geographical residence, psychiatric condition or
 life-threatening disease

 -  Pregnant or breast-feeding subjects

 -  Current participation in clinical trials that potentially interfere with the current
 study