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，旨在检验经皮冠状动脉介入治疗联合最佳药物治疗在减少稳定但高危心肌梗死后患者临床事件方面上级单纯最佳药物治疗的假设。OAT患者在心肌梗死（MI）后3-28天具有完全闭塞的梗死相关动脉和至少一个额外的高风险特征，即左心室功能降低（射血分数< 50%）或近端冠状动脉闭塞。患者在2000年至2005年期间被随机分配到药物治疗组或药物治疗加经皮冠状动脉介入和支架植入组。主要终点是死亡、IV级充血性心力衰竭（CHF）和MI复发的复合终点。在对2，166名入组患者平均随访3年后，治疗组之间的主要终点无显著差异。本竞争性再注册申请建议：A）将随访时间额外延长3年，以实现对OAT队列的平均随访时间约为6年，以检查事件和生活质量的晚期趋势，以及B）对原始OAT队列进行额外的深入分析，随访3年。延长随访也将增加检查预先指定亚组的把握度。延长OAT随访旨在为医学界提供关于MI后最后一次稳定患者中持续闭塞梗死相关动脉的常规PCI策略的风险和获益的明确数据。 OAT有200多个参与临床研究中心，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，马里兰州医学研究所的数据协调中心（DCC）以及杜克临床研究所的经济学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.