美国密苏里大学堪萨斯城分校John A. Spertus课题组比较了冠状动脉疾病侵入或保守治疗的健康状况结果。这一研究成果于2020年3月30日发表在《新英格兰医学杂志》上。

在ISCHEMIA试验中，采用血管造影评估和血运重建的侵入性方案并未减少稳定型缺血性心脏病、中度或重度缺血患者的临床事件。该试验的次要目标是评估这些患者与心绞痛有关的健康状况。

研究组对此前2295名接受侵入性治疗的患者，以及2322名接受保守方案的患者进行了西雅图心绞痛问卷（SAQ）调查，分别于1.5、3和6个月进行，之后每6个月一次，对心绞痛相关症状、功能和生活质量进行评估。此健康分析的主要结果是SAQ得分，0-100，分数越高越健康。

基线时，有35%的患者报告前一个月没有心绞痛。两个治疗组的SAQ总分均增加，侵入性治疗组在3、12和36个月的得分分别比保守方案组高4.1分、4.2分和2.9分。基线时心绞痛发作频率更高的参与者之间差异更大。

总之，对于总体中度或重度缺血人群，接受侵入性治疗与保守方案相比，与心绞痛相关的健康状况有较大改善。无症状患者之间差异最小，基线时有心绞痛的患者之间差异较大。

附：英文原文

Title: Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease | NEJM

Author: John A. Spertus, M.D., M.P.H.,, Philip G. Jones, M.S.,, David J. Maron, M.D.,, Sean M. O’Brien, Ph.D.,, Harmony R. Reynolds, M.D.,, Yves Rosenberg, M.D., M.P.H.,, Gregg W. Stone, M.D.,, Frank E. Harrell, Jr., Ph.D.,, William E. Boden, M.D.,, William S. Weintraub, M.D.,, Khaula Baloch, M.P.H.,, Kreton Mavromatis, M.D.,, Ariel Diaz, M.D.,, Gilbert Gosselin, M.D.,, Jonathan D. Newman, M.D., M.P.H.,, Stavroula Mavromichalis, M.S.,, Karen P. Alexander, M.D.,, David J. Cohen, M.D.,, Sripal Bangalore, M.D., M.H.A.,, Judith S. Hochman, M.D.,, and Daniel B. Mark, M.D., M.P.H.

Issue&Volume: 2020-03-30

Abstract: Abstract

Background

In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.

Methods

We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.

Results

At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).

Conclusions

In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline.

DOI: 10.1056/NEJMoa1916370

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1916370