Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 858
- 试验地点
- 22
- 主要终点
- Net adverse clinical events
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen.
Hypothesis:
Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
- •Uses oral anticoagulation at screening
- •Provided written informed consent
排除标准
- •Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:
- •Mechanical heart valve prosthesis
- •Intracardiac thrombus
- •< 3 months after venous thromboembolism
- •< 6 months after transient ischemic attack or stroke in patients with atrial fibrillation
研究组 & 干预措施
Continuation of oral anticoagulants
干预措施: Continuation of oral anticoagulants (Drug)
Interruption of oral anticoagulants
干预措施: Interruption of oral anticoagulants (Drug)
结局指标
主要结局
Net adverse clinical events
时间窗: 30 days
A composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications at 30 days post TAVI as defined by the VARC-3 criteria
次要结局
- Procedure related thromboembolic complications(30 days)
- All-cause death(30 days)
- Bleeding complications(30 days)
- Cerebrovascular events(30 days)
- Clinical efficacy(30 days)
- Stroke(30 days)
- Early safety(30 days)
- Quality of Life(30 days and 90 days)
- Procedure related primary endpoints(30 days)
- Procedure related bleeding complications(30 days)
- Thromboembolic complications(30 days)
- Neurologic events(30 days)
- Cardiovascular death(30 days)
研究者
Jurriën M. ten Berg, MD, PhD
Professor dr.
St. Antonius Hospital