ISCHEMIA trial update.
ISCHEMIA trial update.
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ISCHEMIA 试验更新。
DOI：
10.1016/j.ahj.2019.09.001
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发表时间：
2019
影响因子：
4.8
通讯作者：
Mark,Daniel
中科院分区：
文献类型：
--
作者：
Spertus,John;Mark,Daniel
正如《美国心脏杂志》最初描述的那样，1 国际医疗和侵入性方法的健康有效性比较研究 (ISCHEMIA) 试验将中度或重度缺血的患者随机分配到早期侵入性或保守治疗策略。治疗稳定型缺血性心脏病患者的主要目标是避免疾病进展并改善他们的健康状况：症状、功能和生活质量。因此，主要疾病进展结局是由5个组成部分组成的复合临床结局（心血管死亡、心肌梗死或因不稳定心绞痛住院、心脏骤停复苏或心力衰竭），关键的次要结局是患者自我报告的健康状况。在最初的研究方案和《美国心脏杂志》的研究描述中，健康状况分析计划重点关注心绞痛症状和心绞痛相关的生活质量，通过心绞痛频率和生活质量来衡量西雅图心绞痛问卷 (SAQ) 的量表。 2 ISCHEMIA 试验资助后，推出了包含 7 项的缩短版 SAQ，不仅减少了 SAQ 的反应负担，还引入了汇总评分，将患者的症状、功能和生活质量整合为一个评分，评分范围从 0（最差的健康状况）到 100（无心绞痛、无身体限制，且对患者的生活质量没有心绞痛相关影响）。 3 由于 SAQ 总结评分整合了冠状动脉疾病对患者健康状况的所有疾病特异性影响，因此我们正在改变原来的分析计划，将 SAQ 总结评分（通过整个研究随访过程中收集的简短症状调查（7 项 SAQ）获得）作为主要健康状况结果和 ISCHEMIA 试验的关键次要终点。
As originally described in the American Heart Journal, 1 the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial has randomized patients with moderate or severe ischemia to an early invasive or conservative treatment strategy. The primary goals of treating patients with stable ischemic heart disease are to avoid disease progression and to improve their health status: their symptoms, function and quality of life. Accordingly, the primary disease progression outcome is a 5-component composite clinical outcome (cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure) and the key secondary outcome is patients’ self-reported health status.In the original study protocol and in the description of the study in the American Heart Journal, the health status analysis plan was to focus on angina symptoms and angina-related quality of life, as measured by the Angina Frequency and Quality of Life Scales from the Seattle Angina Questionnaire (SAQ). 2 Subsequent to funding of the ISCHEMIA trial, a shortened, 7-item, version of the SAQ was introduced that not only reduced the response burden of the SAQ, but also introduced a Summary Score that integrates patients’ symptoms, function and quality of life into a single score that ranges from 0 (the worst health status) to 100 (no angina, no physical limitations and no angina-related impacts on patients’ quality of life). 3 Because the SAQ Summary Score integrates all of the disease-specific impacts of coronary artery disease on patients’ health status, we are altering the original analytic plan to have the SAQ Summary Score, as acquired by the Brief Symptom Survey (7-item SAQ) collected throughout study follow-up, serve as the primary health status outcome and the key secondary endpoint of the ISCHEMIA trial.