BACKGROUND In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status. METHODS We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy. RESULTS Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4). CONCLUSIONS Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).

中文翻译：

---

冠心病和晚期肾脏疾病侵入性或保守治疗后的健康状况。

背景 在 ISCHEMIA-CKD 试验中，初步分析显示，初始血管造影和血运重建加基于指南的药物治疗（侵入性策略）与单独基于指南的药物治疗（保守策略）相比，死亡或心肌梗死的风险没有显着差异。 ）患有稳定型缺血性心脏病、中度或重度缺血和晚期慢性肾病（估计肾小球滤过率每分钟每 1.73 平方米<30 毫升或接受透析）的参与者。该试验的第二个目标是评估与心绞痛相关的健康状况。方法 我们在随机分组前、1.5、3、6 个月以及此后每 6 个月使用西雅图心绞痛问卷 (SAQ) 评估健康状况。该分析的主要结果是 SAQ 总结评分（范围从 0 到 100，分数越高表明心绞痛频率越低，功能和生活质量越好）。贝叶斯框架内的混合效应累积概率模型用于估计侵入性策略的治疗效果。结果 对 777 名参与者中的 705 名进行了健康状况评估。近一半的参与者（49%）在随机分组前一个月内没有出现心绞痛。3 个月时，侵入性策略组和保守性策略组之间 SAQ 总结评分的估计平均差异为 2.1 分（95% 可信区间，-0.4 至 4.6），这一结果有利于侵入性策略。基线时每天或每周心绞痛的参与者中 3 个月时的平均评分差异最大（10.1 分；95% 可信区间，0.0 至 19.9），基线时每月心绞痛的参与者较小（2.2 分；95% 可信区间， -2.0 至 6.2），而在基线时无心绞痛的患者中几乎不存在（0.6 分；95% 可信区间，-1.9 至 3.3）。到 6 个月时，整个试验人群的组间差异减弱（0.5 分；95% 可信区间，-2.2 至 3.4）。结论 与保守策略相比，患有稳定型缺血性心脏病、中度或重度缺血以及晚期慢性肾病的参与者在心绞痛相关的健康状况方面并未获得实质性或持续的益处。（由国家心肺血液研究所资助；ISCHEMIA-CKD ClinicalTrials.gov 编号，NCT01985360。）。