Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,173
- 试验地点
- 12
- 主要终点
- NACEs (net adverse clinical events)
研究概览
简要总结
We had little experience in coronary intervention with recently introduced newer drug-eluting stent (DES) platforms, despite great anticipation, and optimal duration of dual antiplatelet therapy (DAPT) for these stent systems still needs to be established.
Herein, we plan the HOST-coronary intervention with next-generation drug-eluting stent platforms and abbreviated dual antiplatelet therapy (HOST-IDEA) trial to compare single antiplatelet therapy (SAPT) after 3-month DAPT with 12-month DAPT in all-comers undergoing coronary intervention with third-generation DES with the thinnest struts.
P2Y12 inhibitor treatment is added to aspirin during the 3-months period after the stenting, and this abbreviated duration of DAPT will be compared with conventional 1-year mandatory DAPT regimen in a 1:1 randomized stratification.
Net adverse clinical events (NACEs), a composite of cardiac death, target vessel related myocardial infarction, clinically-drivent target lesion revascularization, definite or probable stent thrombosis and major bleeding is a primary endpoint for evaluating safety and efficacy of the difference of DAPT duration.
1-year target lesion failure (TLF) as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization will be identified as a secondary ischemic outcome. 1-year major bleeding events classified as BARC type 3 or 5 bleeding events will be identified as a secondary bleeding outcome.
With this trial, you will be able to get clear insight on the behavior of newer DES platforms. Reference data for the shortened mandatory DAPT regimen will also be delineated in the selected patients, and it might be helpful to those who need it.
详细描述
Every antiplatelet-naïve patient undergoing an elective procedure will be given 300 mg aspirin and loading dose of one of P2Y12 receptor inhibitors (e.g., 600 mg clopidogrel, 60 mg prasugrel or 180 mg ticagrelor) preferably ≥2 hours before the intervention. These loading doses can be waived for chronic antiplatelet users, and prasugrel or ticagrelor can be used instead of clopidogrel. Choice for P2Y12 inhibitors will be left to responsible physicians' discretion, and this decision will be based on the patient/lesional characteristics.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with de novo stenotic lesions who are suitable for coronary stenting with drug-eluting stent
排除标准
- •High risk profiles for ischemic adverse events such as A. ST-segment elevation myocardial infarction (STEMI) B. Patients with cardiogenic shock or concomitant severe decompensated heart failure C. Myocardial infarction or stent thrombosis in spite of the maintenance of antiplatelet therapy D. Restenosis in stented segments or previous sites of balloon angioplasty
- •Patients who cannot follow allocated DAPT schedule due to the planned surgery or elective procedure within 3 months after the stenting
- •Recent history of major surgery or evident events of gastrointestinal bleeding within 1 month from the procedure
- •Patients on anticoagulation therapy with warfarin or other anticoagulants
- •Life expectancy less than 1 year (such as malignancies or other chronic systemic diseases)
- •Pregnant women
- •Past history of allergy or other contraindications for the following medications/materials: aspirin, clopidogrel, heparin, cobalt chromium, sirolimus
研究组 & 干预措施
Orsiro SES or CX-ISAR/3-months DAPT
Patients allocated to this group will be implanted with Orisro sirolimus-eluting stents or Corflex ISAR stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.
干预措施: 3-months DAPT (Drug)
Orsiro SES or CX-ISAR/1-year DAPT
Patients allocated to this group will be implanted with Orisro sirolimus-eluting stents or Coroflex ISAR stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.
干预措施: 1-year DAPT (Drug)
结局指标
主要结局
NACEs (net adverse clinical events)
时间窗: post-stenting 12 months
a composite of cardiac death, target vessel-related non-fatal myocardial infarction, clinically-driven target lesion revascularization, definite or probable stent thrombosis, and major bleeding
次要结局
- TLF (target lesion failure)(post-stenting 12 months)
- Major bleeding(post-stenting 12 months)
研究者
Hyo-Soo Kim
Director of Cardiac Catheterization Laboratory & Coronary Intervention
Seoul National University Hospital