OCCLUDED ARTERY TRIAL--CLINICAL COORDINATING CENTER

背景 在急性心肌梗死（MI）中建立早期冠状动脉再灌注的益处现已明确确立。然而，目前的药理学策略未能在30%或更多的患者中实现有效的再灌注，并且许多患有闭塞的梗死动脉的患者不符合使用这些药物的当前标准。早期血管成形术是一种有效的再灌注方法，可供一小部分可能符合条件的美国急性心肌梗死患者使用。 因此，大量急性心肌梗死患者在再灌注治疗具有任何记录的益处时（12-24小时），梗死血管持续闭合。 一些实验和临床证据表明，这些患者的晚期再灌注可以提供临床上显著的死亡率和发病率降低。 假设：开放动脉试验的中心假设是，在高风险无症状患者（射血分数小于50%或大冠状动脉近端闭塞）中，在急性MI后3-21天开放闭塞的梗死动脉将减少平均3年随访期间的死亡率、复发性MI和因NYHA IV级充血性心力衰竭（CHF）住院治疗的复合终点。具体目标。 该研究将是一项前瞻性临床试验，3，200名患者在两年内按相等比例随机分配到两个治疗组。 一种治疗将包括常规药物管理（包括阿司匹林、β受体阻滞剂、ACE抑制剂和风险因素调整）。 实验治疗将包括常规药物治疗加经皮冠状动脉介入治疗和冠状动脉支架植入术。 将使用意向治疗分析比较临床结局。 我们有一个主要的具体目标：1）根据分配到两种治疗的患者的平均3年随访，比较全因死亡率、非胎儿MI和NYHA IV级CHF住院治疗的复合结局。 我们有三个次要具体目标：1）比较两个治疗组中研究复合主要终点的单个组分。 2)比较两种治疗的医疗费用，并评估研究人群中经皮血运重建术的成本效益。 3)比较两个治疗组的健康相关生活质量。 运营纽约市的卢克-罗斯福医院。 数据协调中心（DCC）位于马里兰州医学研究所。 经济学和生活质量协调中心位于杜克大学。 血管造影核心实验室位于不列颠哥伦比亚省大学。

Background. The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacological strategies fail to achieve effective reperfusion in 30% or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence, a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12-24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. Hypothesis: The central hypothesis of the Open Artery Trial is that opening an occluded infarct artery 3-21 days after an acute MI in high-risk asymptomatic patients (ejection fraction less than 50% or proximal occlusion of a large coronary artery) will reduce the composite endpoint of mortality, recurrent MI, and hospitalization for NYHA class IV congestive hear failure (CHF) over an average three year follow-up. Specific aims. The study will be a prospective clinical trial with 3,200 patients randomly allocated in equal proportions to two tretments arms over two years. One treatment will consist of conventional medical management (including aspirin, beta blockers, ACE inhibitors, and risk factor modification). The experimental treatment will consist of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. We have one primary specific aim: 1) To compare the composite outcome of all-cause mortality, non-fetal MI and hospitalization of NYHA class IV CHF based on an average three year follow-up among patients assigned to the two treatments. We have three secondary specific aims: 1) To compare the individual components of the study composite primary endpoint in the two treatment arms. 2) To compare the medical costs of the two treatments and assess the cost effectiveness of percutaneous revascularization in the study population. 3) To compare health-related quality of life in the two treatment groups. Operations. The Luke's-Roosevelt Hospital in New York City. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute. The Economics and Quality of Life Coordinating Center is at Duke University. The Angiographic Core Laboratory is at the University of British Columbia.