Pepine C J, Geller N L, Knatterud G L, Bourassa M G, Chaitman B R, Davies R F, Day P, Deanfield J E, Goldberg A D, McMahon R P
University of Florida College of Medicine, Division of Cardiovascular Medicine, Gainesville 32610-0277.
J Am Coll Cardiol. 1994 Jul;24(1):1-10. doi: 10.1016/0735-1097(94)90534-7.
The primary objectives of the Asymptomatic Cardiac Ischemia Pilot were 1) to compare the 12-week efficacy of three treatment strategies to suppress cardiac ischemia, and 2) to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia.
Cardiac ischemia has been associated with increased morbidity and mortality. However, most cardiac ischemia is asymptomatic, and although therapeutic strategies ranging from no medication to revascularization are being used to treat ischemia, no prospective study evaluating different treatment strategies has been reported.
Patients with angiographically documented coronary artery disease and ischemia on exercise and ambulatory electrocardiogram (ECG) in 11 clinical units were randomized to receive angina-guided medical therapy, angina-guided plus ambulatory ECG ischemia-guided medical therapy or revascularization (coronary angioplasty or bypass surgery). Patients were also randomized to receive either diltiazem plus isosorbide dinitrate or atenolol plus nifedipine when possible. After anti-ischemic medication adjustment to control angina, blinded medication was adjusted in the medical therapy groups to eliminate ischemia in the ischemia-guided group. The primary outcome was the absence of ischemia at 12 weeks. Follow-up was scheduled for 1 year.
A total of 1,959 patients were screened by ambulatory ECG monitoring; 982 (49%) had asymptomatic ischemia, and 618 (65%) were enrolled in the study. Most patients were men, were > 60 years old and had two or more ischemic episodes, early positive exercise tests and multivessel disease.
Design and baseline data for a pilot study of ischemia treatment strategies are described.
无症状性心肌缺血试验的主要目的为：1）比较三种治疗策略抑制心肌缺血的12周疗效；2）评估对无症状性心肌缺血患者进行预后试验的可行性。
心肌缺血与发病率和死亡率增加相关。然而，大多数心肌缺血是无症状的，尽管从不进行药物治疗到血运重建等各种治疗策略都被用于治疗缺血，但尚无评估不同治疗策略的前瞻性研究报告。
11个临床单位中经血管造影证实有冠状动脉疾病且运动及动态心电图（ECG）显示有缺血的患者被随机分组，分别接受心绞痛指导下的药物治疗、心绞痛指导加动态心电图缺血指导下的药物治疗或血运重建（冠状动脉成形术或搭桥手术）。患者还尽可能被随机分组，分别接受地尔硫䓬加硝酸异山梨酯或阿替洛尔加硝苯地平治疗。在调整抗缺血药物以控制心绞痛后，对药物治疗组进行盲法药物调整，以消除缺血指导组中的缺血情况。主要结局为12周时无缺血。计划随访1年。
通过动态心电图监测共筛查了1959例患者；982例（49%）有无症状性缺血，其中618例（65%）纳入研究。大多数患者为男性，年龄>60岁，有两次或更多次缺血发作、运动试验早期阳性及多支血管病变。
描述了一项缺血治疗策略初步研究的设计和基线数据。
