Background and Aims Overtesting of low-risk patients with suspect chronic coronary syndrome (CCS) is widespread. The acoustic-based coronary artery disease (CAD)-score has superior rule-out capabilities when added to pre-test probability (PTP). FILTER-SCAD tested whether providing a CAD-score and PTP to cardiologists was superior to PTP alone in limiting testing. Methods At six Danish and Swedish outpatient clinics, patients with suspected new-onset CCS were randomized to either standard diagnostic examination (SDE) with PTP, or SDE plus CAD-score, and cardiologists provided with corresponding recommended diagnostic flowcharts. The primary endpoint was cumulative number of diagnostic tests at one year and key safety endpoint major adverse cardiac events (MACE). Results In total, 2008 patients (46% male, median age 63 years) were randomized from October 2019 to September 2022. When randomized to CAD-score (n = 1002), it was successfully measured in 94.5%. Overall, 13.5% had PTP ≤ 5%, and 39.5% had CAD-score ≤ 20. Testing was deferred in 22% with no differences in diagnostic tests between groups (P for superiority = .56). In the PTP ≤ 5% subgroup, the proportion with deferred testing increased from 28% to 52% (P < .001). Overall MACE was 2.4 per 100 person-years. Non-inferiority regarding safety was established, absolute risk difference 0.49% (95% confidence interval −1.96–0.97) (P for non-inferiority = .003). No differences were seen in angina-related health status or quality of life. Conclusions The implementation strategy of providing cardiologists with a CAD-score alongside SDE did not reduce testing overall but indicated a possible role in patients with low CCS likelihood. Further strategies are warranted to address resistance to modifying diagnostic pathways in this patient population.

中文翻译：

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基于声学排除稳定型冠状动脉疾病：FILTER-SCAD 试验


背景和目标 对疑似慢性冠脉综合征 （CCS） 的低风险患者进行过度检测是普遍存在的。基于声学的冠状动脉疾病 （CAD） 评分在添加到验前概率 （PTP） 时具有卓越的排除能力。FILTER-SCAD 测试了在限制测试方面，向心脏病专家提供 CAD 评分和 PTP 是否优于单独使用 PTP。方法 在 6 个丹麦和瑞典门诊，疑似新发 CCS 患者被随机分配到 PTP 标准诊断检查 （SDE） 或 SDE 加 CAD 评分组，心脏病专家提供相应的推荐诊断流程图。主要终点是一年诊断测试的累积次数和关键安全终点主要不良心脏事件 （MACE）。结果 2019 年 10 月至 2022 年 9 月，共有 2008 例患者 （46% 为男性，中位年龄 63 岁） 被随机分组。当随机分配到 CAD 评分 （n = 1002） 时，成功测量了 94.5%。总体而言，13.5% 的 PTP ≤ 5%，39.5% 的 CAD 评分≤ 20。22% 的患者推迟了检测，组间诊断检测没有差异 （优效性 P = .56）。在 PTP ≤ 5% 亚组中，延迟检测的比例从 28% 增加到 52% （P < .001）。总体 MACE 为 2.4/100 人年。建立了安全性的非劣效性，绝对风险差 0.49% （95% 置信区间 -1.96-0.97） （非劣效性的 P = .003）。在心绞痛相关健康状况或生活质量方面未见差异。结论 为心脏病专家提供 CAD 评分和 SDE 的实施策略并没有减少总体检测，但表明在 CCS 可能性低的患者中可能起作用。 需要进一步的策略来解决该患者群体对修改诊断途径的抵抗。