SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 1,800
- 试验地点
- 212
- 主要终点
- Primary Clinical Endpoint of 12-Month Binary MACCE.
研究概览
简要总结
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).
详细描述
Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.
SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.
Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.
Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.
Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
- •De novo lesions with at least 50% stenosis
- •Myocardial ischemia (stable, unstable, silent)
排除标准
- •Prior PCI or CABG
- •Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)
- •Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
- •Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
- •Inability to give informed consent due to mental condition, mental retardation, or language barrier
结局指标
主要结局
Primary Clinical Endpoint of 12-Month Binary MACCE.
时间窗: 12 months post enrollment
Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).
12-month Composite Safety Endpoint.
时间窗: 12 months after enrollment
Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
Repeat Revascularization (PCI and/or CABG).
时间窗: 12 Months post enrollment
Number of participants with repeat revascularization (PCI and/or CABG).
次要结局
- Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.(1 month after procedure and 6 months, 3 years, and 5 years post allocation)
- Individual Components of MACCE at 1 Month Post-procedure.(1 month after procedure)
- Individual Components of MACCE at 6 Months Post-allocation.(6 months post allocation)
- Individual Components of MACCE at 1 Year Post-allocation.(1 year post allocation)
- Freedom From MACCE and Its Components at 1 Year Post-allocation.(1 year post allocation)
- Freedom From MACCE and Its Components at 3 Years Post-allocation(3 years post allocation)
- Freedom From MACCE and Its Components at 5 Years Post-allocation(5 years post allocation)
- Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation(1 month after procedure and 6 months, 1, 3 and 5 years post allocation)
- Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation(1 year, 3 and 5 years post allocation)
- The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)(5 Years)