Boerhout Coen K M, Namba Hanae F, Liu Tommy, Beijk Marcel A M, Damman Peter, Meuwissen Martijn, Ong Peter, Sechtem Udo, Appelman Yolande, Berry Colin, Escaned Javier, Lerman Amir, Henry Timothy D, van der Harst Pim, Delewi Ronak, Piek Jan J, van de Hoef Tim P
Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.
Department of Cardiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
Eur Heart J. 2025 Aug 12. doi: 10.1093/eurheartj/ehaf580.
Invasive coronary function testing (CFT) identifies coronary vasomotor disorders in up to 90% of patients with angina with non-obstructive coronary arteries (ANOCA). The ILIAS ANOCA trial hypothesized that routine ad hoc CFT would be feasible, safe, and effective in providing an early, comprehensive diagnosis. Additionally, it was anticipated that combining CFT with a disease-specific treatment protocol would significantly improve quality of life in ANOCA patients compared with standard care.
After excluding patients with obstructive coronary artery disease (CAD) during clinically indicated invasive coronary angiography (ICA), eligible patients underwent CFT and were randomized to either the standard care group, where CFT results remained blinded, or the intervention group, where CFT results were disclosed along with a tailored medical therapy protocol. The primary outcome was the mean difference in the within-subject change in Seattle Angina Questionnaire summary score (SAQSS) between groups from baseline to a follow-up of 6 months. The trial is registered with the International Clinical Trials Registry Platform (NL-OMON20739).
A total of 255 patients consented, of whom 153 patients (60%) without CAD underwent CFT and were randomized 1:1 to the standard care (n = 76) or intervention group (n = 77). All CFT procedures were successful without adverse events. A vasomotor disorder was identified in 120 patients (78%). At 6-month follow-up, the SAQSS improved significantly in the intervention group compared with the control group, with an intervention effect of 9.4 units (95% confidence interval 3.9-14.9, P = .001). There were no major adverse cardiac events at the 6-month follow-up.
Routine CFT during the initial ICA was feasible, safe, and had high diagnostic yield. Implementing a pragmatic CFT protocol combined with a disease-specific treatment protocol significantly improved disease-related quality of life in patients with ANOCA compared with standard care.
侵入性冠状动脉功能测试（CFT）可在高达90%的非阻塞性冠状动脉性心绞痛（ANOCA）患者中识别出冠状动脉血管舒缩功能障碍。ILIAS ANOCA试验假设，常规的临时CFT在提供早期全面诊断方面将是可行、安全且有效的。此外，预计将CFT与特定疾病治疗方案相结合，与标准治疗相比，将显著改善ANOCA患者的生活质量。
在临床指征的侵入性冠状动脉造影（ICA）过程中排除阻塞性冠状动脉疾病（CAD）患者后，符合条件的患者接受CFT，并随机分为标准治疗组（CFT结果保密）或干预组（CFT结果与定制的药物治疗方案一同披露）。主要结局是两组从基线到6个月随访期间西雅图心绞痛问卷总结评分（SAQSS）的受试者内变化的平均差异。该试验已在国际临床试验注册平台注册（NL-OMON20739）。
共有255名患者同意参与，其中153名无CAD的患者接受了CFT，并按1:1随机分为标准治疗组（n = 76）或干预组（n = 77）。所有CFT操作均成功，无不良事件发生。120名患者（78%）被识别出存在血管舒缩功能障碍。在6个月随访时，与对照组相比，干预组的SAQSS显著改善，干预效果为9.4分（95%置信区间3.9 - 14.9，P = .001）。6个月随访时无重大不良心脏事件发生。
初始ICA期间进行常规CFT是可行、安全的，且诊断率高。与标准治疗相比，实施实用的CFT方案并结合特定疾病治疗方案可显著改善ANOCA患者的疾病相关生活质量。
