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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT guided strategy.
- Who it may be relevant to
- Registry conditions: Severe Aortic Valve Stenosis. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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: a Pragmatic, International, Multicentre, Randomized Clinical Trial
Overview
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.
Interventions
- Radiation CT guided strategy
1. 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 s
Primary outcome measures
- Thromboembolic events [Time frame: Through study completion, a median of 2.5 years]
- All bleeding [Time frame: Through study completion, a median of 2.5 years]
Secondary outcome measures (11)
- 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 [Time frame: Through study completion, a median of 2.5 years]
- Major bleeding (VARC-3 type 2-4) [Time frame: Through study completion, a median of 2.5 years]
- Cerebrovascular events (All stroke and TIA according to VARC-3) [Time frame: Through study completion, a median of 2.5 years]
- Cardiovascular mortality [Time frame: Through study completion, a median of 2.5 years]
- All-cause mortality [Time frame: Through study completion, a median of 2.5 years]
- Aortic bio-prosthetic valve dysfunction assessed by echocardiography yearly after TAVI (standard care), as assessed according the VARC-3 criteria for Bioprosthetic Valve Dysfunction. [Time frame: Through study completion, a median of 2.5 years]
- Quality of life as assessed by EuroQol- 5 Dimension 5 Level (EQ-5D-5L) at baseline, 3 and 12 months, and then yearly after TAVI procedure. [Time frame: Through study completion, a median of 2.5 years]
- Quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and then yearly after TAVI procedure. [Time frame: Through study completion, an median of 2.5 years]
- Quality of life as assessed by Short Form Health Survey (SF-12) at baseline, 3 and 12 months, and then yearly after TAVI procedure. [Time frame: Through study completion, a median of 2.5 years]
- Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization. [Time frame: Through study completion, a median of 2.5 years]
- Cost-effectiveness assassment of a CT-guided antithrombotic strategy after TAVI using EQ-5D-5L [Time frame: Through study completion, a median of 2.5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- St. Antonius Hospital — Nieuwegein
Identifiers
NCT: NCT06168370 · 2023-504637-42-01