OCCLUDED ARTERY TRIAL--CLINICAL COORDINATING CENTER

背景资料。在急性心肌梗死(MI)中建立早期冠脉再通的益处现在已被明确证实。然而，目前的药物治疗策略未能在30%或更多的患者中实现有效的再通，而且许多动脉闭塞的患者不符合目前使用这些药物的标准。早期血管成形术是一种有效的再灌注方法，适用于一小部分可能符合条件的美国急性心肌梗死患者。因此，相当数量的急性心肌梗死患者在持续闭合的梗塞血管再灌注治疗有任何证明的益处时(12-24小时)会消磨时间。一些实验和临床证据表明，这些患者的晚期再灌注可以在临床上显著降低死亡率和发病率。假设：开放动脉试验的中心假设是，在无症状的高危患者(射血分数低于50%或大冠状动脉近端闭塞)急性心肌梗死后3-21天开放闭塞的脑梗塞动脉，将在平均三年的随访中降低死亡率、复发心肌梗死和NYHA IV级充血性心力衰竭(CHF)住院的综合终点。明确的目标。这项研究将是一项前瞻性临床试验，3200名患者在两年内随机等比例分配到两个治疗组。一种治疗将包括传统的医疗管理(包括阿司匹林、β受体阻滞剂、血管紧张素转换酶抑制剂和风险因素修改)。试验性治疗将包括常规药物治疗加上经皮冠状动脉介入治疗和冠状动脉支架置入术。临床结果将使用意向治疗分析进行比较。我们有一个主要的具体目标：1)根据分配到这两种治疗方法的患者平均三年的随访，比较NYHA IV级充血性心力衰竭患者全因死亡率、非胎儿心肌梗死和住院的综合结果。我们有三个次要的具体目标：1)比较两个治疗组中研究复合主要终点的单独组成部分。2)比较两种治疗方法的医疗成本，评估经皮血管重建术在研究人群中的成本效益。3)比较两组患者的健康相关生活质量。行动。纽约市的卢克-罗斯福医院。数据协调中心(DCC)设在马里兰医学研究所。经济和生活质量协调中心设在杜克大学。血管造影术核心实验室位于不列颠哥伦比亚大学。

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.