BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

BARI是一项随机多中心国际临床试验， 初步PTCA策略与初始CABG策略的比较 冠心病患者。经过检验的主要假设是， 初始PTCA不比初始CABG差 病死率为5年。其他主要终点包括：心肌 心肌梗死(MI)，需要重复手术和住院， 症状和功能状态，放射性核素射出分数， 生活质量和经济影响。从1987年开始，调查人员 从14个主要地点和4个卫星随机抽取了1829名患者(45%)。 除了随机队列外，调查人员还招募了 登记了2,013名符合条件但未随机分配的患者 随机抽样422名患者，根据他们的 血管造影。 随机接受初始PTCA的患者在严重程度上相似 疾病、伴随疾病、心脏危险因素和人口统计学 对于那些随机接受冠脉搭桥术的患者。总体而言，该队列的平均年龄为61.5岁 女性占27%，白人占90%，黑人占6%。受试者也有 相当严重的疾病，平均有3.5个明显的病变 平均危及61.5%的左心室(LV)区域。 调查人员建议：完成对所有BARI的5年随访 患者，将随机和登记队列的随访扩展到 至少10年，确定PTCA与CABG的相对疗效 在妇女、黑人和老年人的子组中，并评估公共卫生 巴里的影响。他们提议对所有人进行年度电话采访。 目前登记的患者。所有随机分组的患者都将收到 他们的主治医生的年度静息心电图 任何可疑的心肌梗死和/或血运重建手术。使用说明 在戒烟、锻炼和治疗方面的行为矫正 在每一次后续接触中，都会加强饮食。定期监测 戒烟率和胆固醇水平的变化，尽管 没有关于验血的规定。原始的BARI协议 计划在第5年重复进行血管造影术；然而，由于 报销政策，这将被放射性核素取代 测定射血分数的心脏造影(RNV)。RNV 将在本地阅读，而不是集中阅读，以降低成本。认证 并计划制定质量控制程序，以使RNV标准化 每个站点的测量结果。另一份申请已提交为 6个临床站点的辅助项目，以获得5年的血管造影术 这些地方的病人。然而，同时进行的血管造影术 临床指征将由中心放射实验室读取 (CRL)。在登记患者中，5岁和5岁时将获得心电图 10和任何可疑的心肌梗死或血运重建手术。 数据将从每3天的心脏住院中收集， PTCA、CABG或其他心脏手术，以及因心脏病住院 血管重建术过程中的停滞或并发症。一个辅助者 其他地方资助的研究将比较治疗成本和治疗质量 两个治疗臂的生活问题。调查人员还提议 继续每半年检查一次所有血运重建程序 在BARI站点执行，以提供对 从中选择BARI患者的血管重建术。 将收集有关手术类型、患者人口统计、 以及疾病的严重性。一项类似的调查将在一组 代表实施PTCA和PTCA的机构的医院 以及美国和加拿大的CABG。

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.