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BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

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
依托单位国家:
美国
项目类别:
财政年份:
1987
资助国家:
美国
项目状态:
已结题
起止时间:
1987-06-01 至 1997-11-30

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中文摘要
翻译
旁路血管成形术血运重建调查(BARI)是一项 随机临床试验比较初始治疗方案的相对疗效 多支冠状动脉病变患者PTCA与CABG的治疗策略 以及严重的心绞痛或缺血。治疗策略将与 考虑到临床结果和经济影响。审判开始了 1987年,来自14个主要地点和5颗卫星的调查人员 随机抽取1829名患者。其中43%是老年人,27%是女性,以及 6%的人是黑人。BARI患者发生心脏事件的风险很高;55% 有心肌梗塞病史,69%有不稳定 心绞痛或非Q波心肌梗死。基线时,存在三支血管病变。 41%和73%的人有三个或更多明显的病变(大于或 等于50%狭窄)。截至1993年7月,第一位患者随机 将被跟踪5年,最后一个患者将被 随访2年。 除了这项随机试验,BARI还包含一个由以下内容组成的注册中心 2013名符合条件的非随机患者和422名被认为 根据他们的血管造影术不符合条件。对于随机化和注册 患者,我们建议完成并报告5年随访结果和 将随访时间延长至10年。在随机分组的患者中,治疗 将在死亡率、心肌梗死、心肌梗死、 脑梗塞,需要重复手术和住院,功能性 状态、放射性核素射出分数和生活质量。 围手术期的结果也将被报告。类似的分析将会是 报告了两个登记组的情况。 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方式 在临床站点、中心实验室和NHLBI之间 在这一点上,巴里成功发球。临床站点将依赖于 与他们的病人建立了良好的长期关系 推荐医生。十年的跟踪结果将提供长期的- PTCA与CABG的期限成本,不仅在美元支出方面,而且 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 冠脉血运重建,从而影响数十万人 预计将接受这些程序的患者。
英文摘要
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.
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BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION
BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION (BARI
BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION
BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION (BARI
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