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. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

中文翻译：

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冠心病侵入性或保守治疗的健康状况结果。


背景 在 ISCHEMIA 试验中，血管造影评估和血运重建的侵入性策略并没有减少患有稳定型缺血性心脏病和中度或重度缺血的患者的临床事件。该试验的第二个目标是评估这些患者与心绞痛相关的健康状况。方法 我们在第 1.5、3 和 6 个月以及此后每 6 个月使用西雅图心绞痛问卷 (SAQ) 随机评估被随机分配接受侵入性治疗的参与者的心绞痛相关症状、功能和生活质量策略（2295 名参与者）或保守策略（2322 名）。贝叶斯框架内的混合效应累积概率模型用于估计治疗组之间的差异。该健康状况分析的主要结果是 SAQ 总结分数（分数范围从 0 到 100，分数越高表明健康状况越好）。所有分析均根据基线心绞痛频率在总体人群中进行。结果 在基线时，35% 的患者报告上个月没有出现心绞痛。两个治疗组的 SAQ 总分均有所增加，在第 3、12 和 36 个月时分别增加了 4.1 分（95% 可信区间，3.2 至 5.0）、4.2 分（95% 可信区间，3.3 至 5.1）和 2.9 分（95% 可信区间，2.2 至 3.7）侵入性策略比保守性策略更高。基线时心绞痛更频繁的参与者之间的差异更大（与没有心绞痛的参与者相比，每天或每周心绞痛的参与者在 3 个月时为 8.5 分与 0.1 分，在 36 个月时为 5.3 分与 1.2 分）。 结论 在患有中度或重度缺血的总体试验人群中，其中包括 35% 基线时没有心绞痛的参与者，随机分配到侵入性策略的患者比分配到保守策略的患者在心绞痛相关健康状况方面有更大的改善。整个组中有利于侵入性策略的适度平均差异反映了无症状患者之间的最小差异以及基线时患有心绞痛的患者之间的较大差异。 （由国家心肺血液研究所等资助；ISCHEMIA ClinicalTrials.gov 编号，NCT01471522。）。