BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

总体目标是确定冠状动脉搭桥手术是否 冠状动脉旁路移植术（CABG）比经皮腔内冠状动脉成形术（PTCA）优越上级 用于治疗多支冠状动脉疾病患者， 严重心绞痛 解剖结构适合血运重建的患者， 任何一种方式都将被输入数据登记册，并被用于 在几个预先定义的亚组（不稳定型心绞痛，年龄 大于70，左心室功能差，既往接受过旁路手术）。 随机化将导致分配至PTCA或CABG， 指定的血运重建手术将在2周内进行， 随机化 这两种技术的长期安全性和有效性将在 使用3个主要终点进行比较：1）无重大心脏事件 （心源性或猝死，非致命性心肌梗死，重复 血运重建手术，再住院≥ 5 不稳定型心绞痛天数）、生活质量评分（心绞痛、心绞痛、 药物使用，运动能力），和3）净经济成本超过4 年随访期。 计划的随访导管插入术将 在4年时进行，以评估血运重建的通畅性 干预 除上述终点外，还将努力 定义最适合成功PTCA的解剖学子集，并评估 所有病变“完全”血运重建的比较疗效 直径减小大于或等于70%与“不完全” 仅一个或多个“罪犯”病变的血运重建。 所有数据将 在数据注册表中累积，以定义这两个 血运重建方法。 考虑到冠状动脉疾病的广泛性， 与旁路手术相关，以及PTCA可能能够 以较低的经济成本提供可比的效益，这是至关重要的 进行这样一个随机临床试验。 这项建议 寻求申请机构参与，作为几个临床 参与本试验设计、执行和分析的临床试验机构。

The overall goal is to determine whether coronary artery bypass surgery (CABG) is superior to percutaneous transluminal coronary angioplasty (PTCA) for the treatment of multivessel coronary artery disease in patients with severe angina. Patients with anatomy suitable for revascularization by either modality will be entered into a data registry, and approached for randomization within several pre-defined subgroups (unstable angina, age greater than 70, poor left ventricular function, prior bypass surgery). Randomization will result in assignment either to PTCA or to CABG, and the assigned revascularization procedure will be performed within 2 weeks of randomization. Long-term safety and efficacy of the two techniques will be compared using 3 major endpoints: 1) freedom from major cardiac event (cardiac or sudden death, non-fatal myocardial infarction, repeat revascularization procedure, rehospitalization greater than or equal to 5 days for unstable angina), quality of life score (angina, cardiac medication used, exercise capacity), and 3) net economic cost over the 4 year follow-up period. Scheduled follow-up catheterization will be performed at 4 years to assess patency of the revascularization intervention. In addition to the above endpoints, efforts will be made to define anatomic subsets most amenable to successful PTCA, and to evaluate the comparative efficacy of "complete" revascularization of all lesions greater than or equal to 70% diameter reduction versus "incomplete" revascularization of only one or more "culprit" lesions. All data will be accumulated in a data registry to define the current status of these two revascularization methods. Given the widespread nature of coronary artery disease, the expense associated with bypass surgery, and the potential that PTCA may be able to provide comparable benefit at lower economic cost, it is vitally important to perform such a randomized clinical trial at this time. This proposal seeks participation of the applicant institution as one of several clinical centers participating in the design, execution, and analysis of this trial.