CABG PATCH TRIAL--DATA COORDINATING CENTER

冠状动脉搭桥术贴片试验是一项多中心、随机对照的临床试验 试验验证植入型心律转复除颤器的假设 (ICD)治疗将提高冠心病患者的存活率 死亡风险高，特别是心律失常死亡，即 严重的左心功能不全，同时也有心律失常的标志 风险(阳性信号平均心电图)。为了解决这个问题，病人们 如果患有冠状动脉疾病，将被登记为冠心病患者 动脉搭桥手术，年龄都不到80岁，都离开了 心室射血分数小于0.36，并有积极的信号 平均心电图。这一群体与已经接受治疗的患者相似 持续性室性心律失常，因此有迹象表明 在当前指南下进行ICD治疗。此外，这组人有很高的 随诊期间发生死亡的概率。治疗和治疗 对照组在慢性病的另一个重要方面表现得很好 冠心病--发生缺血性事件的风险。两组都有 在试验开始时重新血运重建具有潜在的优势 锐化终点，即所有死亡的较小比例是 预计是缺血的，预计更大比例的是 心律失常，一种通过治疗得到极佳治疗的病理生理学 正在研究中。入选的患者将在手术期间随机进行 是否收到ICD。我们计划对800名患者进行随机抽样，其中一半是 对照组，一半给ICD组。将对患者进行跟踪治疗 随机化后平均三年。冠状动脉旁路移植术贴片试验 在40个月内检测到假设减少40%的能力为80%-85% ICD治疗组全因死亡率的风险率。在……里面 此外，CABG贴片试验将：记录ICD的任何发病率 评估ICD治疗对生活质量的影响；以及 ICD治疗与对照组的医疗费用比较 一群人。在最狭义的解释中，结果将适用于高 接受冠脉搭桥术的冠心病高危患者。另外， 结果应实质上适用于符合当前标准的患者 ICD治疗和其他一些高危冠心病的适应症 尚未发生心律失常事件的疾病患者。

The CABG Patch Trial is a multicenter, randomized controlled clinical trial to test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve survival in coronary heart disease patients at high risk of death, especially arrhythmic death, i.e., patients with severe left ventricular dysfunction who also have a marker of arrhythmic risk (positive signal averaged ECG). To address this question, patients with coronary heart disease will be enrolled if they are having coronary artery bypass graft surgery, are less than 80 years of age, have left ventricular ejection fraction less than 0.36, and have a positive signal averaged ECG. This group is similar to the patients who already have had a sustained ventricular arrhythmia and therefore have an indication for ICD treatment under current guidelines. Also, the group has a high probability of experiencing death during follow-up. The treatment and control groups are well matched for another important aspect of chronic coronary heart disease - risk for ischemic events. Having both groups revascularized at the beginning of the trial has the potential advantage of sharpening the endpoint, i.e., a smaller proportion of all deaths are expected to be ischemic, and a larger proportion are expected to be arrhythmic, a pathophysiology that is addressed superbly by the treatment under study. Enrolled patients will be randomized during surgery to receive an ICD or not. We plan to randomize 800 patients, half to the control group and half to the ICD group. Patients will be followed for an average of three years after randomization. The CABG Patch Trial has 80%-85% power to detect a hypothesized 40% reduction in the 40-month hazard rate for all-cause mortality in the ICD treated group. In addition, The CABG Patch Trial will: document any morbidity of ICD treatment; evaluate the effects of ICD therapy on quality of life; and compare the health care costs of ICD treatment with those in the control group. In the narrowest interpretation, the results will apply to high risk coronary heart disease patients undergoing CABG surgery. Also, the results should apply substantially to patients who satisfy the current indications for ICD treatment and to some other high risk coronary heart disease patients who have not yet had an arrhythmic event.