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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Thromboembolic events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CT guided strategy
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.
干预措施: CT guided strategy (Radiation)
Standard care
Standard of care with lifelong SAPT after TAVI
结局指标
主要结局
Thromboembolic events
时间窗: Through study completion, a median of 2.5 years
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
时间窗: Through study completion, a median of 2.5 years
Defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria
次要结局
- Major bleeding (VARC-3 type 2-4)(Through study completion, a median of 2.5 years)
- Cost-effectiveness assassment of a CT-guided antithrombotic strategy after TAVI using EQ-5D-5L(Through study completion, a median of 2.5 years)
- 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(Through study completion, a median of 2.5 years)
- Cerebrovascular events (All stroke and TIA according to VARC-3)(Through study completion, a median of 2.5 years)
- Cardiovascular mortality(Through study completion, a median of 2.5 years)
- All-cause mortality(Through study completion, a 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.(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.(Through study completion, an 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.(Through study completion, a median of 2.5 years)
- Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization.(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.(Through study completion, a median of 2.5 years)
研究者
Jurriën M. ten Berg, MD, PhD
Clinical Professor
St. Antonius Hospital