BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

旁路血管成形术血运重建研究

• 批准号: 2218911
• 负责人: BERTRAM PITT
• 金额: $ 11.92万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-06-01 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2218911
• 关键词: angina pectoris; angiocardiography; clinical trials; coronary bypass; coronary disorder; heart catheterization; heart revascularization; human subject; human therapy evaluation; intraluminal angioplasty; longitudinal human study; patient /disease registry; prognosis

The Bypass Angioplasty Revascularization Investigation (BARI) is a randomized clinical trial to compare the relative efficacy of an initial strategy of PTCA vs. CABG in patients with multivessel coronary disease and severe angina or ischemia. Treatment strategies will be compared to respect to clinical outcome and economic impact. The trial was initiated in 1987 and investigators from 14 primary sites and 5 satellites have randomized 1829 patients. Of these, 43% are elderly, 27% are female, and 6% are black. BARI patients are at high risk for cardiac events; 55% presented with a history of myocardial infarction, and 69% with unstable angina or non Q-wave MI. At baseline, triple-vessel disease was present in 41% and 73% had three or more significant lesions (greater than or equal to 50% stenosis). As of July 1993, the first patient randomized will have been followed for 5 years and the last patient will have been followed for 2 years. In addition to the randomized trial, BARI contains a registry comprised of 2013 eligible-not-randomized patients and a sample of 422 patients deemed ineligible based on their angiogram. For both randomized and registry patients, we propose to complete and report 5-year follow-up results and extend follow-up to 10 years. In randomized patients, treatment strategies will be compared with respect to mortality, myocardial infarction, need for repeat procedures and hospitalizations, functional status, radionuclide ejection fraction and quality of life. Periprocedural outcome will also be reported. Similar analyses will be reported for both registry groups. To accomplish 10-year follow-up, we will use the same methods of data collection and management, and continue the same lines of communication between the clinical sites, central laboratories 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. Ten-year follow-up results will provide the long- term cost of PTCA vs. CABG, not only in terms of dollar expenditures but in terms of quality of life, morbidity and longevity. The results of BARI will have an important impact on the future practice of coronary revascularization and thus affect hundreds of thousands of patients who are expected to undergo these procedures.

旁路血管成形术血运重建研究 (BARI) 是一项 比较初始治疗相对疗效的随机临床试验 多支冠状动脉疾病患者的 PTCA 与 CABG 策略 以及严重的心绞痛或缺血。 将比较治疗策略 尊重临床结果和经济影响。 审判已启动 1987 年，来自 14 个主要站点和 5 个卫星的调查人员 随机分组了 1829 名患者。 其中，43%为老年人，27%为女性， 6% 是黑人。 BARI 患者发生心脏事件的风险很高； 55% 有心肌梗塞病史，其中 69% 病情不稳定 心绞痛或非 Q 波心肌梗死。 基线时存在三支血管疾病 41% 和 73% 的患者有三个或更多明显病变（大于或 等于 50% 狭窄）。 截至 1993 年 7 月，第一位患者被随机分组 将被跟踪 5 年，最后一位患者将被 跟随了2年。 除了随机试验之外，BARI 还包含一个注册表，其中包括 2013 名符合条件的非随机患者和 422 名被认为患者的样本 根据他们的血管造影不符合资格。 对于随机和注册 患者，我们建议完成并报告 5 年随访结果，以及 将随访期延长至 10 年。 在随机分组的患者中，治疗 将在死亡率、心肌病等方面对策略进行比较 梗塞，需要重复手术和住院治疗，功能性 状态、放射性核素射血分数和生活质量。 还将报告围手术期结果。 类似的分析将 为两个注册表组报告。 为了完成10年的随访，我们将使用相同的数据方法 收集和管理，并继续保持相同的沟通渠道 临床中心、中心实验室和 NHLBI 之间 至此，BARI 已成功服务。 临床地点将依赖于 与患者建立的良好的长期关系以及 转诊医生。 十年的随访结果将提供长期 PTCA 与 CABG 的长期成本，不仅体现在美元支出方面，还体现在 在生活质量、发病率和寿命方面。 BARI的结果将对未来的实践产生重要影响 冠状动脉血运重建，从而影响数十万 预计接受这些手术的患者。