The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events.
After 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.
Successful TAVI (according to the VARC-3 criteria)10 with any approved device
Ability to understand and to comply with the study protocol
Written informed consent
Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)
Creatinine clearance <15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy
Parallel
CT guided strategy
Radiation1. With signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI are switched from SAPT to apixaban. Patients fulfilling the dose reduction criteria according to the drug label, or with a Clinical Frailty Scale ≥4 will receive 2.5mg bid, patients not meeting these criteria will receive a standard dose of 5mg bid. 2. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT. 3. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.
Thromboembolic events
Composite of cardiovascular death, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism and clinically significant valve thrombosis according to the VARC-3 criteria
All bleeding
Defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria
Net clinical benefit, defined as the composite of cardiovascular mortality, stroke, transient ischaemic attack, systemic embolism, clinically significant valve thrombosis and type 1-4 bleeding according to the VARC-3 criteria
Major bleeding (VARC-3 type 2-4)
Cerebrovascular events (All stroke and TIA according to VARC-3)
Cardiovascular mortality
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St. Antonius Hospital
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Pitié-Salpêtrière Hospital
Collaborator
