BARI CLINICAL UNITS

本研究的目的是比较 经皮冠状动脉腔内成形术（PTCA）和冠状动脉搭桥术 冠状动脉旁路移植术（CABG）作为缓解心肌缺血的手段， 有症状的多支冠状动脉疾病患者。 具体 目的包括：1）确定PTCA是否与CABG一样有效， 缓解运动引起的心肌缺血; 2）确定是否 冠状动脉事件如死亡和心肌梗死的发生率 在接受PTCA或CABG治疗的患者中; 3）确定PTCA是否 导致比CABG更低的病态事件发生率; 4）评估 PTCA缓解心肌缺血的持续效果; 5）评估PTCA对心肌缺血的影响。 CABG和PTCA对就业的影响; 6）评估经济成本 与每项干预措施相关，包括短期和长期。 致残性慢性心绞痛、不稳定型心绞痛患者， 心肌梗死后心绞痛 心电图证据显示运动诱发的缺血或患者 轻度心绞痛和明显心肌缺血的证据， 罗得岛医院的导管插入术将被认为是潜在的 随机分配到PTCA或冠状动脉搭桥手术的候选人。 患有原发性心肌或瓣膜心脏的导管插入患者 患有冠心病或无冠心病证据，或不符合 将考虑功能标准入组观察性研究 注册表 同意随机化的患者将接受全面的 基线评估，包括分级运动试验（如适用）， 进行PTCA或CABG。 随机化患者将 随后进行定期问卷调查，在12岁时进行分级运动压力测试， 和48个月，作为方案的补充， 12和60个月。 进入登记研究的患者的临床结局 将通过问卷调查进行评估。 的主要终点 调查将是显示证据的患者比例 在12个月和48个月时评估运动诱导的缺血。 多个次级 还将根据以下具体目标监测终点： 调查

The objective of this investigation is to compare the effectiveness of percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery (CABG) as means of achieving relief of myocardial ischemia in patients with symptomatic multivessel coronary artery disease. Specific aims include: 1) to determine whether PTCA is as effective as CABG in relieving exercise induced myocardial ischemia; 2) to determine whether the incidence of coronary events such as death and myocardial infarction differ among patients treated with PTCA or CABG; 3) to determine whether PTCA results in a lower incidence of morbid events than CABG; 4) to assess the lasting effect of PTCA in relieving myocardial ischemia; 5) to assess the impact of CABG and PTCA on employment; 6) to assess the economic costs associated with each intervention, both short and long term. Patients with disabling chronic angina pectoris, unstable angina pectoris, angina pectoris following myocardial infarction associated with electrocardiographic evidence of exercise induced ischemia or patients with mild angina and evidence of marked myocardial ischemia who undergo cardiac catheterization at Rhode Island Hospital will be considered potential candidates for randomization to PTCA or coronary bypass surgery. Catheterized patients who do have primary myocardial or valvular heart disease or no evidence of coronary disease or who do not meet one of the functional criteria will be considered for enrollment in an observational Registry. Patients who consent to randomization will undergo a thorough baseline assessment including graded exercise tests if appropriate, prior to performance of either PTCA or CABG. Randomized patients will be followed with periodic questionnaires, graded exercise stress tests at 12 and 48 months and as supplement to the protocol, cardiac catheterization at 12 and 60 months. The clinical outcome of patients entering the Registry will be assessed by means of a questionnaire. The primary endpoint of this investigation will be the proportion of patients demonstrating evidence of exercise induced ischemia assessed at 12 and 48 months. Multiple secondary end points will also be monitored in accordance with the specific aims of the investigation.