Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Transprosthetic aortic gradient
研究概览
简要总结
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
详细描述
Aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. Current guidelines support the use of aspirin (AAS) 100 mg as a class I indication.
Current evidence, mainly derived from transaortic valve implantation (TAVI) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. Anticoagulation in this cases improve leaflet mobility and decrease in gradient. Evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. Nonetheless, current American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend (IIa) the use of warfarin for at least 3 months after aortic valve replacement.
The aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. Comparison will be performed between the use of warfarin + aspirin vs aspirin alone. Duration of anticoagulation will be for 3 months and patients follow-up for 1 year. Clinical and echocardiographic evaluation will be performed in every patients. Some patients will undergo Positron Emission Tomography (PET-Scan).
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
- 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
- •Patients with indication of aortic valve replacement with porcine bioprosthesis
排除标准
- •Concomitant mitral valve replacement
- •Previous atrial fibrillation
- •Previous use oral anticoagulation
- •Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy)
- •Jehovah witness
- •Platelet count below 90,
- •Liver disease
研究组 & 干预措施
Warfarin
Warfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months.
Aspirin will be administered 100 mg daily.
干预措施: Warfarin (Drug)
Warfarin
Warfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months.
Aspirin will be administered 100 mg daily.
干预措施: Aspirin (Drug)
Aspirin only
Aspirin will be started 48-72h after aortic valve replacement. Dose will be 100 mg daily. Patients who undergo coronary artery revascularization will receive 325 mg daily.
干预措施: Aspirin (Drug)
结局指标
主要结局
Transprosthetic aortic gradient
时间窗: 3 months and 1 year
Change in Transprosthetic mean gradient
Change in New York Heart Association (NYHA) class
时间窗: 1 year
NYHA class
次要结局
- Embolic events(3 months and 1 year)
- Prosthetic leak(3 months and 1 year)
- Major bleeding(3 months and 1 year)
研究者
Victor Dayan
Cardiac Surgeon
Instituto Nacional de Cirugia Cardiaca, Uruguay