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

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия 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

Первичные конечные точки

• Thromboembolic events [Срок оценки: Through study completion, a median of 2.5 years]
• All bleeding [Срок оценки: Through study completion, a median of 2.5 years]

Вторичные конечные точки (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 [Срок оценки: Through study completion, a median of 2.5 years]
• Major bleeding (VARC-3 type 2-4) [Срок оценки: Through study completion, a median of 2.5 years]
• Cerebrovascular events (All stroke and TIA according to VARC-3) [Срок оценки: Through study completion, a median of 2.5 years]
• Cardiovascular mortality [Срок оценки: Through study completion, a median of 2.5 years]
• All-cause mortality [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Through study completion, a median of 2.5 years]
• Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization. [Срок оценки: Through study completion, a median of 2.5 years]
• Cost-effectiveness assassment of a CT-guided antithrombotic strategy after TAVI using EQ-5D-5L [Срок оценки: Through study completion, a median of 2.5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• St. Antonius Hospital — Nieuwegein

Идентификаторы

NCT: NCT06168370 · 2023-504637-42-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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