Occluded Artery Trial: Long Term Follow-Up

描述(由申请人提供)： 闭塞动脉试验(OAT)是一项由NHLBI资助的国际多中心随机试验，测试了这样一个假设，即在稳定但高风险的心肌梗死后患者中，采用最佳药物治疗的经皮冠状动脉介入治疗在减少临床事件方面优于单独使用最佳药物治疗。OAT患者在心肌梗死后3-28天完全闭塞了与心肌梗死相关的动脉，并且至少有一个额外的高危特征，要么是左心功能降低(射血分数和50%)，要么是冠状动脉近端闭塞。在2000至2005年间，患者被随机分为两组，一组接受医疗治疗，另一组接受经皮冠状动脉介入治疗和支架植入术。主要终点是死亡、IV级充血性心力衰竭(CHF)和复发性心力衰竭。在对2166名登记的患者进行了平均三年的随访后，治疗组之间的主要终点没有显著差异。这项竞争性延长申请建议：(A)将后续行动再延长3年，以实现对审查处队列的平均约6年的后续行动，以审查事件和生活质量的后期趋势；(B)对最初的审查处队列进行更深入的分析，然后再进行3年。延长的后续行动还将增加检查预先指定的亚组的能力。延长OAT的随访旨在为医学界提供明确的数据，说明在Mi后最后一次稳定的患者中，对持续闭塞的梗塞相关动脉进行常规PCI的策略的风险和好处。 OAT有200多个参与临床站点，包括纽约大学医学院的临床协调中心(CCC)、西奈山医学中心(迈阿密)的Co-CCC、马里兰医学研究所的数据协调中心(DCC)和杜克临床研究所的经济和生活质量协调中心。

DESCRIPTION (provided by applicant): The Occluded Artery Trial (OAT) is an NHLBI-funded international, multicenter, randomized trial testing the hypothesis that percutaneous coronary intervention with optimal medical therapy is superior in reducing clinical events compared to optimal medical therapy alone in stable, but high-risk, post-myocardial infarction patients. OAT patients have totally occluded infarct-related arteries 3-28 days after myocardial infarction (Ml) and at least one additional high risk feature, either reduced left ventricular function (ejection fraction < 50%) or proximal coronary artery occlusion. Patients were randomized between 2000 and 2005 to either medical management or medical management plus percutaneous coronary intervention and stenting. The primary endpoint was a composite of death, class IV congestive heart failure (CHF) and recurrent Ml. After an average of three years of follow up of 2,166 enrolled patients, there was no significant difference between the treatment groups for the primary endpoint. This application for a competitive renewal proposes: A) to extend follow up by an additional 3 years to achieve an average follow up of approximately 6 years on the OAT cohort to examine late trends in events and quality of life and B) to perform additional in depth analyses on the original OAT cohort followed by 3 years. Extended follow up will also increase power to examine prespecified subgroups. Extension of follow up in OAT is designed to provide the medical community with definitive data on the risks and benefits of a strategy of routine PCI of persistently occluded infarct-related arteries in stable patients last post-Mi. OAT has over 200 participating clinical sites, a Clinical Coordinating Center (CCC) at New York University Medical School, a Co-CCC at Mount Sinai Medical Center (Miami), a Data Coordinating Center (DCC) at Maryland Medical Research Institute and an Economics and Quality of Life Coordinating Center at Duke Clinical Research Institute.