BARI STUDY

旁路血管成形术血运重建调查(BARI)是一项 比较初始方案的随机多中心临床试验 经皮冠状动脉腔内成形术(PTCA)恢复至初始水平 冠状动脉旁路移植术(CABG)适用于部分患者 多支冠状动脉疾病。检验的主要假设是 初始PTCA策略不比初始CABG策略差。 关于五年的死亡率。其他主要终端包括： 心肌梗死，需要重复手术和住院， 功能状态、放射性核素射出分数、生活质量和 对经济的影响。 审判于1987年7月开始。来自14个主要地点和4个地点的调查人员 卫星随机选择了1,829名患者。也被招募到一个登记处 有2,013名符合条件但未随机抽样的患者 422名患者根据他们的血管造影被认为符合条件。重要 随机队列中代表的子组包括老年人(43%)， 女性(27%)和非裔美国人(6%)，导致人数最多 曾在任何血管重建试验中研究过的这类患者。中环 放射学实验室复查证实存在三支血管病变 41%的患者和73%的患者有三个或更多明显的冠状动脉病变。 最初协议中的后续行动包括去诊所就诊，打电话 接触，休息和运动的心电图和血脂超过一年 五年的期限。到1993年7月，第一个患者将是 随访五年，最后一名患者随访两年。 随机和登记的患者，我们建议完成并报告 5年随访结果，包括围手术期结果，并延长 随访10年。为了完成10年的跟踪调查，我们将使用 相同的数据收集和管理方法，并延续相同的路线 临床站点、中心实验室、数据之间的通信 协调中心和已成功为BARI服务的NHLBI 这一点。临床站点将长期依靠优秀的 与他们的病人和推荐医生建立了关系。 延期的请求是基于先前的观察结果，即 可能会在5到10年内丢失，因此基于以下结论 5年的随访可能与观察到的有很大不同 后来。这种差异尤其重要，因为慢性 冠心病的性质和认识到许多人的发病年龄 受试者可能相对较早。此外，PTCA作为一种 冠脉搭桥术的辅助因素可能只有在后期的随访中才明显。巴里是 当代PTCA和CABG最大、最全面的比较。 此外，其数据库将允许最大限度地进行广泛的分析 描述这些流行的血运重建程序。结果是 巴里将对中国的医学实践产生巨大的影响 随着我们进入下个世纪，冠心病患者。

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.