无症状性心肌缺血试点（ACIP）研究：随机接受药物治疗或血运重建的无症状性心肌缺血患者1年的结局。ACIP研究人员。

Asymptomatic Cardiac Ischemia Pilot (ACIP) study: outcome at 1 year for patients with asymptomatic cardiac ischemia randomized to medical therapy or revascularization. The ACIP Investigators.

作者信息

Rogers W J, Bourassa M G, Andrews T C, Bertolet B D, Blumenthal R S, Chaitman B R, Forman S A, Geller N L, Goldberg A D, Habib G B

机构信息

University of Alabama Medical Center, Department of Medicine, Birmingham 35294, USA.

出版信息

J Am Coll Cardiol. 1995 Sep;26(3):594-605. doi: 10.1016/0735-1097(95)00228-v.

DOI:10.1016/0735-1097(95)00228-v

PMID:7642848

Abstract

OBJECTIVES

This report discusses the outcome at 1 year in patients in the Asymptomatic Cardiac Ischemia Pilot (ACIP) study.

BACKGROUND

Comparative efficacy of medical therapy versus revascularization in treatment of asymptomatic ischemia is unknown. The ACIP study assessed the ability of three treatment strategies to suppress ambulatory electrocardiographic (ECG) ischemia to determine whether a large-scale trial studying the impact of these strategies on clinical outcomes was feasible.

METHODS

Five hundred fifty-eight patients with coronary anatomy amenable to revascularization, at least one episode of asymptomatic ischemia on the 48-h ambulatory ECG and ischemia on treadmill exercise testing were randomized to one of three treatment strategies: 1) medication to suppress angina (angina-guided strategy, n = 183); 2) medication to suppress both angina and ambulatory ECG ischemia (ischemia-guided strategy, n = 183); or 3) revascularization strategy (angioplasty or bypass surgery, n = 192). Medication was titrated atenolol-nifedipine or diltiazem-isosorbide dinitrate.

RESULTS

The revascularization group received less medication and had less ischemia on serial ambulatory ECG recordings and exercise testing than those assigned to the medical strategies. The ischemia-guided group received more medication but had suppression of ischemia similar to the angina-guided group. At 1 year, the mortality rate was 4.4% in the angina-guided group (8 of 183), 1.6% in the ischemia-guided group (3 of 183) and 0% in the revascularization group (overall, p = 0.004; angina-guided vs. revascularization, p = 0.003; other pairwise comparisons, p = NS). Frequency of myocardial infarction, unstable angina, stroke and congestive heart failure was not significantly different among the three strategies. The revascularization group had significantly fewer hospital admissions and nonprotocol revascularizations at 1 year. The incidence of death, myocardial infarction, nonprotocol revascularization or hospital admissions at 1 year was 32% with the angina-guided medical strategy, 31% with the ischemia-guided medical strategy and 18% with the revascularization strategy (p = 0.003).

CONCLUSIONS

After 1 year, revascularization was superior to both angina-guided and ischemia-guided medical strategies in suppressing asymptomatic ischemia and was associated with better outcome. These findings require confirmation by a larger scale trial.

摘要

目的

本报告讨论无症状性心脏缺血试点（ACIP）研究中患者1年时的结局。

背景

药物治疗与血运重建术在无症状性缺血治疗中的比较疗效尚不清楚。ACIP研究评估了三种治疗策略抑制动态心电图（ECG）缺血的能力，以确定一项研究这些策略对临床结局影响的大规模试验是否可行。

方法

558例冠状动脉解剖结构适合血运重建、48小时动态心电图至少有一次无症状性缺血发作且平板运动试验有缺血表现的患者被随机分配至三种治疗策略之一：1）抑制心绞痛的药物治疗（心绞痛导向策略，n = 183）；2）抑制心绞痛和动态心电图缺血的药物治疗（缺血导向策略，n = 183）；或3）血运重建策略（血管成形术或搭桥手术，n = 192）。药物滴定使用阿替洛尔-硝苯地平或地尔硫卓-硝酸异山梨酯。

结果

与采用药物策略的患者相比，血运重建组服用的药物更少，连续动态心电图记录和运动试验中的缺血也更少。缺血导向组服用的药物更多，但缺血抑制情况与心绞痛导向组相似。1年时，心绞痛导向组的死亡率为4.4%（183例中的8例），缺血导向组为1.6%（183例中的3例），血运重建组为0%（总体，p = 0.004；心绞痛导向组与血运重建组，p = 0.003；其他两两比较，p = 无显著差异）。三种策略中心肌梗死、不稳定型心绞痛、中风和充血性心力衰竭的发生率无显著差异。血运重建组1年时的住院次数和非方案血运重建显著更少。1年时，心绞痛导向药物策略的死亡、心肌梗死、非方案血运重建或住院发生率为32%，缺血导向药物策略为31%，血运重建策略为18%（p = 0.003）。