Coronary function testing vs angiography alone to guide treatment of angina with non-obstructive coronary arteries: the ILIAS ANOCA trial.

The ILIAS ANOCA trial hypothesized that routine ad hoc CFT would be feasible, safe, and effective in providing an early, comprehensive diagnosis.

ILIAS ANOCA试验假设，常规的即兴CFT在提供早期、全面诊断方面是可行的、安全的和有效的。

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.

此外，预计结合冠状动脉功能测试（CFT）与特定疾病的治疗方案将显著改善无阻塞性冠状动脉疾病（ANOCA）患者的生存质量，与标准护理相比。

Methods

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.

在排除了在临床指示下进行侵入性冠状动脉造影（ICA）时发现有阻塞性冠状动脉疾病（CAD）的患者后，符合条件的患者接受了冠状动脉功能测试（CFT），并被随机分配到标准护理组，其中CFT结果保持盲法，或干预组，其中CFT结果被披露，并配合定制的药物治疗方案。

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.

主要结果是两组受试者在基线至随访6个月期间，西雅图心绞痛问卷总分（SAQSS）组内变化的平均差异。

The trial is registered with the International Clinical Trials Registry Platform (NL-OMON20739).

该试验已在国际临床试验注册平台注册（NL-OMON20739）。

Results

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).

共有255名患者同意参与，其中153名（60%）无冠状动脉疾病（CAD）的患者接受了冠状动脉功能测试（CFT），并按1:1的比例随机分为标准治疗组（n = 76）和干预组（n = 77）。

All CFT procedures were successful without adverse events.

所有CFT程序均成功完成，未发生不良事件。

A vasomotor disorder was identified in 120 patients (78%).

在120名患者中，有92名（78%）被诊断出血管运动功能障碍。

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 interval3.9-14.9, P = .001).

在6个月的随访中，干预组的SAQSS评分与对照组相比显著提高，干预效果为9.4个单位（95%置信区间3.9-14.9，P = .001）。

There were no major adverse cardiac events at the 6-month follow-up.

在6个月的随访中没有发生主要不良心脏事件。

Conclusions

Routine CFT during the initial ICA was feasible, safe, and had high diagnostic yield.

在初次冠状动脉造影（ICA）期间进行常规冠状动脉功能测试（CFT）是可行的、安全的，并且具有高诊断价值。

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.

实施一种实用的CFT协议，结合特定疾病的治疗方案，显著提高了ANOCA患者的疾病相关生活质量，与标准护理相比。