近日，美国密苏里大学堪萨斯城分校John A. Spertus小组分析了冠脉疾病晚期肾病患者在侵入或保守治疗后的健康状况。相关论文发表在2020年3月30日出版的《新英格兰医学杂志》上。

在ISCHEMIA-CKD试验中，主要分析显示，对于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患者，与单纯的药物治疗（保守方案）相比，初次血管造影和血运重建联合药物治疗（侵入性治疗）在死亡或心肌梗塞的风险上并无显著差异。该试验的次要目标是评估与心绞痛有关的健康状况。

研究组采用西雅图心绞痛问卷（SAQ）分别在1.5、3和6个月以及之后每6个月对两组患者的健康状况进行评分。主要结果是SAQ得分，0-100，分数越高证明心绞痛发生率越低，功能和生活质量越好。

777名参与者中有705名进行了健康状况评估。在随机分组前的一个月中，将近一半的参与者（49%）没有心绞痛。 在3个月时，侵入性治疗组的SAQ评分和保守方案组之间的估计平均差异为2.1分，该结果支持侵入性治疗。

基线时每日或每周心绞痛发作的参与者在3个月时的平均得分差异最大，为10.1分；基线时每月心绞痛发作的参与者平均得分差异为2.2分；基线时无心绞痛的参与者几乎不存在差异，仅为0.6分。到6个月时，总体试验人群的组间差异已大幅减弱，仅为0.5分。

总之，对于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患者，采用初始侵入性治疗与保守方案相比，在心绞痛相关的健康状况方面并未获得实质性或持续性的益处。

附：英文原文

Title: Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease | NEJM

Author: John A. Spertus, M.D., M.P.H.,, Philip G. Jones, M.S.,, David J. Maron, M.D.,, Daniel B. Mark, M.D., M.P.H.,, Sean M. O’Brien, Ph.D.,, Jerome L. Fleg, M.D.,, Harmony R. Reynolds, M.D.,, Gregg W. Stone, M.D.,, Mandeep S. Sidhu, M.D.,, Bernard R. Chaitman, M.D.,, Glenn M. Chertow, M.D.,, Judith S. Hochman, M.D.,, and Sripal Bangalore, M.D., M.H.A.

Issue&Volume: 2020-03-30

Abstract: Abstract

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.

DOI: 10.1056/NEJMoa1916374

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1916374