University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality and Saint Luke's Mid America Heart Institute, (N.I., J.A.S., D.N., Z.F., P.G.J.).
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan (N.I., S.K.).
Circ Cardiovasc Qual Outcomes. 2024 Oct;17(10):e010534. doi: 10.1161/CIRCOUTCOMES.123.010534. Epub 2024 Sep 20.
The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) demonstrated greater health status benefits with an initial invasive strategy, as compared with a conservative one, for patients with chronic coronary disease and moderate or severe ischemia. Whether these benefits vary globally is important to understand to support global adoption of the results.
We analyzed participants' disease-specific health status using the validated 7-item Seattle Angina Questionnaire (SAQ: >5-point differences are clinically important) at baseline and over 1-year follow-up across 37 countries in 6 international regions. The average effect of initial invasive versus conservative strategies on 1-year SAQ scores was estimated using Bayesian proportional odds regression and compared across regions.
Considerable regional variation in baseline health status was observed among 4617 participants (mean age=64.4±9.5 years, 24% women), with the mean SAQ summary scores of 67.4±19.5 in Eastern Europe participants (17% of the total), 71.4±15.4 in Asia-Pacific (18%), 74.9±16.7 in Central and South America (10%), 75.5±19.5 in Western Europe (26%), and 78.6±19.2 in North America (28%). One-year improvements in SAQ scores were greater in regions with lower baseline scores with initial invasive management (17.7±20.9 in Eastern Europe and 11.4±19.3 in North America), but similar in the conservative arm. Adjusting for baseline SAQ scores, similar health status benefits of an initial invasive strategy on 1-year SAQ scores were observed (ranging from 2.38 points [95% CI, 0.04-4.50] in North America to 4.66 points [95% CI, 2.46-6.94] in Eastern Europe), with an 88.3% probability that the difference in benefit across regions was <5 points.
In patients with chronic coronary disease and moderate or severe ischemia, initial invasive management was associated with a consistent health status benefit across regions, with modest regional variability, supporting the international generalizability of health status benefits from invasive management of chronic coronary disease.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
ISCHEMIA 试验（国际比较健康效果研究，比较药物和介入治疗）表明，对于患有慢性冠状动脉疾病且存在中度或重度缺血的患者，初始采用侵入性策略比保守策略具有更大的健康状况获益。了解这些获益是否存在全球差异非常重要，这有助于支持全球采用该研究结果。
我们使用经过验证的 7 项西雅图心绞痛问卷（SAQ：>5 分的差异具有临床意义），分析了来自 6 个国际区域的 37 个国家的 4617 名参与者在基线和 1 年随访期间的疾病特异性健康状况。使用贝叶斯比例优势比回归估计初始侵入性与保守策略对 1 年 SAQ 评分的平均影响，并在各区域之间进行比较。
在 4617 名参与者（平均年龄 64.4±9.5 岁，24%为女性）中观察到基线健康状况存在明显的区域差异，东欧参与者的平均 SAQ 综合评分（占总数的 17%）为 67.4±19.5，亚太地区为 71.4±15.4，中美洲和南美洲为 74.9±16.7，西欧为 75.5±19.5，北美为 78.6±19.2。采用初始侵入性管理的地区，SAQ 评分的改善幅度更大，基线评分较低（东欧为 17.7±20.9，北美为 11.4±19.3），但在保守治疗组中相似。调整基线 SAQ 评分后，初始侵入性策略对 1 年 SAQ 评分的健康状况获益相似（范围从北美 2.38 分[95%CI，0.04-4.50]到东欧 4.66 分[95%CI，2.46-6.94]），区域间获益差异<5 分的概率为 88.3%。
对于患有慢性冠状动脉疾病且存在中度或重度缺血的患者，初始侵入性治疗与各区域的一致健康状况获益相关，具有适度的区域差异，支持慢性冠状动脉疾病侵入性治疗的健康状况获益具有国际普遍性。
