A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 3,020
- 试验地点
- 1
- 主要终点
- Composite of major adverse cardiovascular events
研究概览
简要总结
DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years old
- •Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- •Significant coronary de novo lesion
排除标准
- •Acute myocardial infarction
- •Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
- •Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions
- •Cardiogenic shock or experience of cardiopulmonary resuscitation
- •Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media
- •History of documented prior cerebrovascular attack within 6 months
- •Treated with any stent within 3 months
- •Reference vessel diameter <2.25 mm or >4.0 mm
- •Pregnant women or women with potential childbearing
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Inability to understand or read the informed content
研究组 & 干预措施
Short-term DAPT after Biofreedom
干预措施: BioFreedom with 1 month DAPT (Device)
Long-term DAPT after BioMatrix or Ultimaster
干预措施: BioMatrix or Ultimaster with 6 to 12 months DAPT (Device)
结局指标
主要结局
Composite of major adverse cardiovascular events
时间窗: 1 year
events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident
次要结局
未报告次要终点