BARI STUDY

旁路血管成形术血运重建研究（巴里）是一项 一项随机多中心临床试验， 经皮腔内冠状动脉成形术（PTCA）的初始 冠状动脉旁路移植术（CABG）的选择患者， 多支冠状动脉疾病 检验的主要假设是 初始PTCA的策略并不比初始CABG的策略差， 五年的死亡率。 其他主要终点包括： 心肌梗死，需要重复手术和住院治疗， 功能状态、放射性核素射血分数、生活质量和 经济影响。 审判于1987年7月开始。 来自14家主要研究中心和4家 卫星随机分配了1，829名患者。 也被招募到一个登记册 有2,013名患者符合条件但未随机分组， 422例患者根据其血管造影照片被视为合格。 重要 随机分组中的亚组包括老年人（43%）， 女性（27%）和非洲裔美国人（6%），导致最多的人数 在任何血运重建试验中研究过的此类患者。 中央 影像学实验室检查证实存在三支血管病变 41%的患者和73%的患者有3处或3处以上严重冠状动脉病变。 原始方案中的随访包括门诊访视、电话随访 接触，休息和运动心电图，血脂超过一个 为期五年。 到1993年7月，第一个病人将 最后一名患者随访了两年。 随机化和登记研究患者，我们建议完成并报告 5-年随访结果，包括围手术期结局，并延长 随访10年。 为了完成10年随访，我们将使用 相同的数据收集和管理方法， 临床研究中心、中心实验室、数据 协调中心和NHLBI成功地为巴里服务， 这一点 临床研究中心将依赖于优秀的长期 与患者和转诊医生建立关系。 延期请求是基于先前的意见，即 的CABG可能会在5到10年之间丢失，因此结论基于 5年随访的结果可能与观察到的结果有很大不同 后 这种差异对于慢性病患者来说特别重要。 冠状动脉疾病的性质和认识，发病年龄在许多 受试者可能相对较早。 此外，PTCA作为一种 CABG的辅助治疗可能仅在后期随访时才明显。 巴里是 最大和最全面的当代PTCA和CABG比较。 此外，其数据库将允许进行广泛的分析， 描述这些流行的血运重建手术。 的结果 巴里将对医学实践产生巨大的影响， 冠状动脉疾病的患者，因为我们进入下一个世纪。

The Bypass Angioplasty Revascularization Investigation (BARI) is a randomized multicenter clinical trial that compares a strategy of initial percutaneous transluminal coronary angioplasty (PTCA) to that of initial coronary artery bypass graft surgery (CABG) for selected patients with multivessel coronary artery disease. The primary hypothesis tested is that a strategy of initial PTCA is no worse than one of initial CABG with respect to mortality at five years. Other major endpoints include: myocardial infarction, need for repeat procedures and hospitalizations, functional status, radionuclide ejection fraction, quality of life and economic impact. The trial began July, 1987. Investigators from 14 primary sites and 4 satellites have randomized 1,829 patients. Also recruited into a registry were 2,013 patients who were eligible but not randomized and a sample of 422 patients deemed eligible based on their angiogram. Important subgroups represented in the randomized cohort include older adults (43%), women (27%), and African Americans (6%), resulting in the largest number of such patients ever studied in any revascularization trial. Central radiographic laboratory review confirmed three-vessel disease was present in 41% of patients and 73% had three or more significant coronary lesions. Follow-up in the original protocol includes clinic visits, telephone contacts, rest and exercise electrocardiograms, and blood lipids over a period of five years. By July 1993, the first patient will have been followed five years and the last patient followed two years. Both randomized and registry patients, we propose to complete and report 5-year follow-up results, including periprocedural outcome, and extend follow-up to 10 years. To accomplish 10-year follow-up, we will use the same methods of data collection and management and continue the same lines of communication among the clinical sites, central laboratories, the data coordinating center and the NHLBI that have served BARI successfully to this point. The clinical sites will rely on the excellent long-term relationships established with their patients and referring physicians. The request for extension is based on prior observations that the benefit of CABG may be lost between five and 10 years and thus conclusions based on 5 years of follow-up may differ substantially from those observed later. Such differences are of particular importance give the chronic nature of coronary disease and recognition that the age of onset in many subjects may be relatively early. Moreover, the role of PTCA as an adjunct to CABG may only be evident during late follow-up. BARI is the largest and most comprehensive comparison of contemporary PTCA and CABG. Furthermore, its data base will allow extensive analyses to best characterize these popular revascularization procedures. The results of BARI will exert an enormous influence on the practice of medicine for patients with coronary artery disease as we enter the next century.