Ikemura Nobuhiro, Jones Philip G, Fu Zhuxuan, Chan Paul S, Sherrod Charles F, Arnold Suzanne V, Cohen David J, Mark Daniel B, Maron David J, Hochman Judith S, Spertus John A
Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA; University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality, Kansas City, Missouri, USA; Department of Cardiology, Keio University School of Medicine, Tokyo, Japan; Department of Internal Medicine, Tachikawa Hospital, Tachikawa, Japan.
Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA; University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality, Kansas City, Missouri, USA.
J Am Coll Cardiol. 2025 Sep 16;86(11):782-793. doi: 10.1016/j.jacc.2025.06.044.
Clinical trials typically report average health status outcomes by treatment at single points in time, as opposed to participants' trajectories (or journeys) over time. Although ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) demonstrated better mean health status at discrete times with an invasive treatment among those with baseline angina, the patterns of individual participants' angina over time are unknown.
The purpose of this study was to identify patterns of individual participants' angina over time after invasive or conservative management strategies for chronic coronary disease.
In this secondary analysis of the ISCHEMIA trial, which enrolled participants with chronic coronary disease and moderate to severe ischemia from July 2012 to January 2018, we used ordinal latent trajectory analysis to assess angina frequency over a 2-year period, separately for participants assigned to the initial invasive and initial conservative arms. Angina frequency was defined using the SAQ-AF (Seattle Angina Questionnaire Angina Frequency) score, recategorized as daily/weekly (0-60 points), monthly (61-99 points), and no angina (100 points). Participants without baseline angina were excluded.
Among 2,977 participants with baseline angina, 1,505 (50.6%) were randomized to initial invasive and 1,472 (49.4%) to initial conservative management; baseline characteristics were well balanced between groups. Six distinct patterns of angina trajectories were identified in each arm and were qualitatively similar: 1) rapid resolution; 2) gradual resolution; 3) early improvement with persistent infrequent angina; 4) severe angina with improvement; 5) modest angina with minimal change; and 6) severe angina without improvement. In the invasive group, the most common patterns included rapid resolution (27.1%) and early improvement with persistent infrequent angina (32.1%), whereas the conservative group more often showed modest angina with minimal change (42.1%) and fewer cases of rapid resolution (12.8%) or early improvement with persistent infrequent angina (10.2%).
Patients with chronic coronary disease and angina experienced diverse symptom trajectories, ranging from rapid resolution to severe or persistent angina. A greater proportion of conservatively managed patients experienced unfavorable angina patterns over 2 years compared with those treated invasively. When health status is monitored over time, such patterns may help identify patients with persistent symptoms who could benefit from additional therapy. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).
临床试验通常报告在单个时间点的治疗平均健康状况结果,而非参与者随时间的轨迹(或历程)。尽管缺血性心脏病比较医疗与侵入性治疗对健康影响的国际研究(ISCHEMIA)显示,在有基线心绞痛的患者中,侵入性治疗在离散时间点的平均健康状况更好,但个体参与者心绞痛随时间的模式尚不清楚。
本研究的目的是确定慢性冠状动脉疾病采用侵入性或保守管理策略后,个体参与者心绞痛随时间的模式。
在ISCHEMIA试验的这项二次分析中,该试验于2012年7月至2018年1月纳入了患有慢性冠状动脉疾病和中度至重度缺血的参与者,我们使用有序潜在轨迹分析来评估2年期间的心绞痛频率,分别针对分配到初始侵入性和初始保守治疗组的参与者。心绞痛频率使用西雅图心绞痛问卷心绞痛频率(SAQ - AF)评分定义,重新分类为每日/每周(0 - 60分)、每月(61 - 99分)和无心绞痛(100分)。排除无基线心绞痛的参与者。
在2977例有基线心绞痛的参与者中,1505例(50.6%)被随机分配至初始侵入性治疗组,1472例(49.4%)被随机分配至初始保守治疗组;两组基线特征均衡。在每组中均识别出六种不同的心绞痛轨迹模式,且在性质上相似:1)快速缓解;2)逐渐缓解;3)早期改善但仍有偶尔心绞痛;4)严重心绞痛且有改善;5)轻度心绞痛且变化极小;6)严重心绞痛且无改善。在侵入性治疗组中,最常见的模式包括快速缓解(27.1%)和早期改善但仍有偶尔心绞痛(32.1%),而保守治疗组更常表现为轻度心绞痛且变化极小(42.1%),快速缓解(12.8%)或早期改善但仍有偶尔心绞痛(10.2%)的病例较少。
患有慢性冠状动脉疾病和心绞痛的患者经历了从快速缓解到严重或持续性心绞痛的多种症状轨迹。与接受侵入性治疗的患者相比,更大比例的接受保守治疗的患者在2年期间经历了不良的心绞痛模式。当随时间监测健康状况时,这些模式可能有助于识别可能从额外治疗中获益的有持续症状的患者。(缺血性心脏病比较医疗与侵入性治疗对健康影响的国际研究[ISCHEMIA];NCT01471522)