BARI STUDY

拟议方案 巴里是一项随机多中心国际临床试验， 比较了初始PTCA和初始CABG的策略， CAD患者测试的主要假设是， 当通过以下评估时，初始PTCA并不比初始CABG差 5年死亡率。其他主要终点包括：心肌 梗死（MI），需要重复手术和住院治疗， 症状和功能状态，放射性核素射血分数， 生活质量和经济影响。从1987年开始，调查人员 来自14个主要研究中心和4个卫星研究中心的1，829名患者（45%）随机分组。 除了随机队列外，研究人员还招募了 一项登记研究，2，013例合格但未随机化的患者， 随机抽取了422名患者，根据他们的 血管造影。 随机分配至初始PTCA组的患者， 疾病、伴随疾病、心脏风险因素和人口统计学 随机接受CABG的患者。总体而言，该队列的平均年龄为61.5岁， 27%为女性，90%为白色，6%为黑人。受试者还具有 平均有3.5个显著病变的稍微晚期疾病， 平均危及61.5%的左心室（LV）区域。 研究者建议：完成所有巴里的5年随访 患者，将随机化和登记研究队列的随访延长至 至少10年，确定PTCA与CABG的相对疗效 在妇女、黑人和老年人的亚组中， 巴里影响。他们建议每年对所有人进行电话采访 患者目前已登记。所有随机化患者将接受 由其主治医生提供的年度静息心电图（ECG）， 任何疑似MI和/或血运重建手术。说明书 在戒烟、锻炼和 在每次随访联系时将加强饮食。定期监测 戒烟率和胆固醇水平的建议，虽然 没有规定验血。最初的巴里协议 计划在第5年进行重复血管造影;然而，由于 这将被放射性核素取代 心室造影（RNV）用于测定射血分数。RNV 将在当地而不是集中阅读，以降低成本。认证 并计划质量控制程序，以标准化RNV 在每个站点进行测量。另一份申请已提交， 6家临床试验机构的辅助项目，以获得5年血管造影照片， 患者在这些地方。然而，获得的并发血管造影片 临床适应症将由中央放射实验室解读 （CRL）。在登记研究患者中，将在第5年获得ECG， 10和任何疑似MI或血运重建手术。 将从>3天的每次心脏住院收集数据， PTCA、CABG或其他心脏手术，以及因心脏病住院治疗 血运重建手术导致的心脏骤停或并发症。辅助 其他地方资助的研究将比较治疗费用和治疗质量。 2个治疗组的生活问题。调查人员还建议， 继续每半年对所有血运重建手术进行一次调查 在巴里研究所进行的研究， 选择巴里患者的血运重建手术。 将收集关于手术类型、患者人口统计学资料， 疾病的严重性。一项类似的调查将在一组 具有代表性的医院进行了PTCA， 和冠状动脉旁路移植术。

PROPOSED PROGRAM BARI is a randomized multicenter international clinical trial that compares a strategy of initial PTCA to that of initial CABG for selected patients with CAD. The primary hypothesis tested is that a strategy of initial PTCA is no worse than one of initial CABG when assessed by mortality at 5 years. Other major endpoints include: myocardial infarction (MI), need for repeat procedures and hospitalizations, symptomatic and functional status, radionuclide ejection fraction, quality of life, and economic impact. Beginning in 1987, investigators from 14 primary sites and 4 satellites randomized 1,829 patients (45%). In addition to the randomized cohort, the investigators recruited into a registry 2,013 patients who were eligible but not randomized and a random sample of 422 patients deemed ineligible based on their angiogram. The patients randomized to initial PTCA were similar in severity of disease, concomitant diseases, cardiac risk factors, and demographics to those randomized to CABG. Overall, the cohort had a mean age of 61.5 years and is 27% female, 90% white, and 6% black. Subjects also had somewhat advanced disease with a mean of 3.5 significant lesions which on the average jeopardized 61.5% of left ventricular (LV) territory. The investigators propose to: complete the 5-year followup on all BARI patients, extend the followup of the randomized and registry cohorts to a minimum of 10 years, determine the relative efficacy of PTCA vs. CABG in subgroups of women, blacks, and elderly, and assess the public health impact of BARI. They propose annual telephone interviews for all patients currently enrolled. All randomized patients will receive an annual rest electrocardiogram (ECG) from their primary physician and for any suspected MI and/or revascularization procedure. Instruction for behavior modification in the areas of smoking cessation, exercise, and diet will be reinforced at each followup contact. Periodic monitoring of smoking cessation rates and cholesterol levels are proposed, although no provision for blood testing is provided. The original BARI protocol planned for repeat angiography at year 5; however, due to changes in reimbursement policies, this will be replaced by a radionuclide ventriculogram (RNV) for determination of ejection fraction. The RNVs will be read locally rather than centrally to reduce costs. Certification and quality control procedures are planned to standardize the RNV measurements at each site. A separate application has been submitted as an ancillary project by 6 clinical sites to obtain 5-year angiograms in patients at these sites. However, intercurrent angiograms obtained for clinical indications will be read by the Central Radiographic Laboratory (CRL). In the registry patients, ECGs will be obtained at years 5 and 10 and for any suspected MI or revascularization procedure. Data will be collected from each cardiac hospitalization of >3 days, PTCA, CABG, or other cardiac procedure, and hospitalization for cardiac arrest or complication from a revascularization procedure. An ancillary study funded elsewhere will compare cost of treatment and quality of life issues in the 2 treatment arms. The investigators also propose to continue semiannual surveys of all revascularization procedures performed at BARI sites to provide estimates of the "universe" of revascularization procedures from which the BARI patients were selected. Data will be collected on the type of procedure, patient demographics, and disease severity. A similar survey will be conducted in a group of hospitals that are representative of institutions that perform both PTCA and CABG in the United States and Canada.