NCT05125367已完成不适用
Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease: The BEST Extended 10 Y Follow-up
Seung-Jung Park24 个研究点 分布在 4 个国家目标入组 880 人开始时间: 2022年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 880
- 试验地点
- 24
- 主要终点
- Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR)
研究概览
简要总结
The primary objective of the BEST extended 10Y follow-up study is to compare the safety and effectiveness of coronary stent implantation using everolimus-eluting balloon-expandable stents with bypass grafting for the treatment of multivessel coronary artery disease at minimum of 10 years follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age 18 years or older
- •Angiographically confirmed multivessel coronary artery disease [critical (>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter) at least two separate coronary artery territories (the right coronary artery (RCA), left circumflex artery (LCX) and left anterior descending (LAD)] and are expected to be equally treatable with PCI(Percutaneous Coronary Intervention) or CABG(coronary artery bypass graft) by interventionalists and surgeons at the investigating site.
- •Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- •Geographically accessible and willing to come in for required study visits
- •Signed informed consent.
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •Both Clopidogrel and TIclopidine
- •Sirolimus, paclitaxel, ABT 578
- •Stainless steel and/or
- •Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •Severe congestive heart failure (class III or IV according to New York Heart Association (NYHA) Functional Classification, or pulmonary edema) at the time of enrollment. The degree of left ventricular ejection fraction is not considered as an index of exclusion.
- •Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- •Prior CABG surgery
- •Prior PCI with DES implantation within 1 year
- •Two or more chronic total occlusions in major coronary territories
- •Acute ST-elevation myocardial infarction(Q-wave) within 72 hours prior to enrollment requiring revascularization.
- •Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization. When the cardiac enzyme is returned to normal, those can be enrolled.
- •Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement.
- •Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
- •Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES(drug eluting stent) related anticoagulation.
- •Contraindication either CABG or PCI/DES because of a coexisting clinical condition
- •Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- •Suspected pregnancy.
- •Concurrent enrollment in another clinical trial
- •Left main stenosis (at least 50% diameter stenosis)
结局指标
主要结局
Major adverse cardiac event (MACE) including all-cause mortality, myocardial infarction, or target vessel revascularization (TVR)
时间窗: 10-year
A composite endpoint(MACE) is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. Definitions for primary and secondary clinical outcomes are consistent with those used in the original BEST trial protocol(NCT00997828).
次要结局
- Target vessel revascularization (TVR)(10-year)
- Composite of death, myocardial infarction, stroke, or any repeat revascularization(10-year)
- All-cause death(10-year)
- Myocardial infarction(10-year)
- Stroke(10-year)
- Any repeat revascularization(10-year)
- Composite of death, myocardial infarction, or stroke(10-year)
研究者
Seung-Jung Park
Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
Asan Medical Center
研究点 (24)
Loading locations...
相似试验
终止
不适用
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®HIVNCT01579695Theratechnologies391
Unknown
不适用
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two LevelsDegenerative Disc DiseaseCervical Disc DiseaseNCT05691231NuVasive158
进行中（未招募）
不适用
Long-term Assessment of the Safety and Performance of the NuVasive Simplify DiscDegenerative Disc DiseaseCervical Disc DiseaseNCT05258435NuVasive131
招募中
不适用
Resting Full-cycle Ratio (RFR)-Guided RevascularizationCoronary Artery DiseaseNCT06075160Sejong General Hospital1,167
已完成
不适用
Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological DeficitSpine FractureSpine, Fracture LumbarThoracic Spine FractureThoracolumbar Burst FractureFracture of Spine, Level UnspecifiedSpine FusionNCT06059820Sklifosovsky Institute of Emergency Care40