Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation (POP ATLANTIS)

St. Antonius Hospital

Status: Enrolling

Conditions: Severe Aortic Valve Stenosis

Treatments: Radiation: CT guided strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06168370

2023-504637-42-01

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

CT guided strategy

Experimental group

Description:

The intervention group will undergo CT scan after 3 months. If subclinical valve thrombosis is detected, anticoagulation will be started. If no subclinical valve thrombosis is detected, the SAPT is stopped, unless another indication is present.

Treatment:

Radiation: CT guided strategy

Standard care

No Intervention group

Description:

Standard of care with lifelong SAPT after TAVI