Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,042
- 试验地点
- 7
- 主要终点
- Net adverse clinical events (NACE)
研究概览
简要总结
The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon.
The main questions it aims to answer are:
Does stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment?
Researchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up.
Participants will:
Be randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time
详细描述
Coronary artery disease is a major cause of morbidity and mortality worldwide. Percutaneous coronary intervention is widely used for the treatment of coronary artery disease, traditionally involving implantation of drug-eluting stents. Although contemporary drug-eluting stents have improved safety and efficacy compared with earlier stent technologies, permanent metallic implants remain associated with long-term considerations, including restenosis, stent thrombosis, and the need for prolonged antiplatelet therapy.
Drug-coated balloon therapy represents an alternative revascularization strategy that delivers an antiproliferative drug to the coronary vessel wall without implantation of a permanent scaffold. This "leave-nothing-behind" approach has been adopted in specific clinical settings and has been increasingly applied in selected coronary lesions. The absence of a permanent implant may offer potential advantages with respect to long-term vessel healing and antiplatelet therapy management.
Bleeding complications after coronary intervention are clinically relevant and have been associated with adverse outcomes. Decisions regarding the duration of antiplatelet therapy require careful consideration of both ischemic and bleeding risks. While shorter durations of antiplatelet therapy have been explored following contemporary coronary interventions, optimal long-term antiplatelet strategies after drug-coated balloon-based procedures remain incompletely defined.
Limited data are available regarding the clinical outcomes associated with discontinuation of antiplatelet therapy beyond 12 months in patients who have undergone initial percutaneous coronary intervention using drug-coated balloon treatment and have remained clinically stable. As a result, uncertainty persists regarding the balance of potential benefits and risks of long-term antiplatelet therapy in this population.
This prospective, randomized, multicenter study is designed to compare clinical outcomes between patients who discontinue antiplatelet therapy and those who continue antiplatelet therapy after 12 months following drug-coated balloon-based percutaneous coronary intervention. The study aims to provide additional evidence to inform clinical decision-making regarding antiplatelet therapy management in patients treated with drug-coated balloons.
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
- •Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.
- •Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.
- •Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.
- •Patients who have not experienced major bleeding since the index DCB treatment.
- •Patients who are receiving antiplatelet therapy at the time of enrollment.
排除标准
- •Patients with concomitant vascular disease requiring long-term antiplatelet therapy.
- •Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.
- •Patients who are participating in another drug or coronary device clinical study at the time of enrollment.
研究组 & 干预措施
Stop Antiplatelet
Antiplatelet discontinuation group
干预措施: Stop Antiplatelet (Drug)
Continue Antiplatelet
Antiplatelet continuation group
干预措施: Continue Antiplatelet (Drug)
结局指标
主要结局
Net adverse clinical events (NACE)
时间窗: Up to 12 months after randomization
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5. Non-fatal myocardial infarction is defined as a myocardial infarction diagnosed using standard clinical, electrocardiographic, and biomarker criteria that does not result in death.
次要结局
- NACE(Up to 24, 36 months after randomization)
- The single components of the primary endpoint(Up to 12, 24, 36 months after randomization)
- Rate of cardiac death(Up to 12, 24, 36 months after randomization)
- Stroke (ischemic and hemorrhagic)(Up to 12, 24, 36 months after randomization)
- Target lesion failure(Up to 12, 24, 36 months after randomization)
- Angina severity measured with Seattle Angina Questionnaires(At baseline and 12 months after randomization)
- Cost-effectiveness(Up to 12, 24, 36 months after randomization)
- Sex difference in NACE(Up to 12, 24, 36 months after randomization)
- Comparison of NACE in DM patients(Up to 12, 24, 36 months after randomization)
- NACE in patients with acute coronary syndrome(Up to 12, 24, 36 months after randomization)
研究者
Eun-Seok Shin
Professor
Ulsan University Hospital