Department of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Section on Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
JAMA Cardiol. 2023 Apr 1;8(4):347-356. doi: 10.1001/jamacardio.2023.0031.
The European Society of Cardiology (ESC) 0/1-hour algorithm is a validated high-sensitivity cardiac troponin (hs-cTn) protocol for emergency department patients with possible acute coronary syndrome. However, limited data exist regarding its performance in patients with known coronary artery disease (CAD; prior myocardial infarction [MI], coronary revascularization, or ≥70% coronary stenosis).
To evaluate and compare the diagnostic performance of the ESC 0/1-hour algorithm for 30-day cardiac death or MI among patients with and without known CAD and determine if the algorithm could achieve the negative predictive value rule-out threshold of 99% or higher.
DESIGN, SETTING, AND PARTICIPANTS: This was a preplanned subgroup analysis of the STOP-CP prospective multisite cohort study, which was conducted from January 25, 2017, through September 6, 2018, at 8 emergency departments in the US. Patients 21 years or older with symptoms suggestive of acute coronary syndrome without ST-segment elevation on initial electrocardiogram were included. Analysis took place between February and December 2022.
INTERVENTIONS/EXPOSURES: Participants with 0- and 1-hour high-sensitivity cardiac troponin T (hs-cTnT) measures were stratified into rule-out, observation, and rule-in zones using the ESC 0/1-hour hs-cTnT algorithm.
Cardiac death or MI at 30 days determined by expert adjudicators.
During the study period, 1430 patients were accrued. In the cohort, 775 individuals (54.2%) were male, 826 (57.8%) were White, and the mean (SD) age was 57.6 (12.8) years. At 30 days, cardiac death or MI occurred in 183 participants (12.8%). Known CAD was present in 449 (31.4%). Among patients with known CAD, the ESC 0/1-hour algorithm classified 178 of 449 (39.6%) into the rule-out zone compared with 648 of 981 (66.1%) without CAD (P < .001). Among rule-out zone patients, 30-day cardiac death or MI occurred in 6 of 178 patients (3.4%) with known CAD and 7 of 648 (1.1%) without CAD (P < .001). The negative predictive value for 30-day cardiac death or MI was 96.6% (95% CI, 92.8-98.8) among patients with known CAD and 98.9% (95% CI, 97.8-99.6) in patients without known CAD (P = .04).
Among patients with known CAD, the ESC 0/1-hour hs-cTnT algorithm was unable to safely exclude 30-day cardiac death or MI. This suggests that clinicians should be cautious if using the algorithm in patients with known CAD. The negative predictive value was significantly higher in patients without a history of CAD but remained less than 99%.
欧洲心脏病学会（ESC）0/1 小时算法是一种经过验证的用于急诊科可能发生急性冠状动脉综合征的患者的高敏心肌肌钙蛋白（hs-cTn）方案。然而，关于该方案在已知冠心病（CAD；既往心肌梗死[MI]、冠状动脉血运重建或≥70%冠状动脉狭窄）患者中的表现，数据有限。
评估和比较 ESC 0/1 小时算法在有和无已知 CAD 的患者中用于 30 天心脏死亡或 MI 的诊断性能，并确定该算法是否可以达到 99%或更高的阴性预测值排除阈值。
设计、设置和参与者：这是 STOP-CP 前瞻性多地点队列研究的预先计划的亚组分析，该研究于 2017 年 1 月 25 日至 2018 年 9 月 6 日在美国 8 家急诊室进行。纳入有疑似急性冠状动脉综合征症状且初始心电图无 ST 段抬高的 21 岁及以上患者。分析于 2022 年 2 月至 12 月进行。
干预措施/暴露：使用 ESC 0/1 小时 hs-cTnT 算法，将 0 小时和 1 小时高敏心肌肌钙蛋白 T（hs-cTnT）测量值的患者分层为排除、观察和纳入区。
由专家裁决确定的 30 天内的心脏死亡或 MI。
在研究期间，共纳入了 1430 名患者。在队列中，775 名患者（54.2%）为男性，826 名患者（57.8%）为白人，平均（SD）年龄为 57.6（12.8）岁。在 30 天内，有 183 名患者（12.8%）发生心脏死亡或 MI。已知 CAD 存在于 449 名患者（31.4%）中。在已知 CAD 患者中，ESC 0/1 小时算法将 449 名患者中的 178 名（39.6%）分类为排除区，而 981 名患者中无 CAD 的患者为 648 名（66.1%）（P<.001）。在排除区患者中，6 名已知 CAD 患者（3.4%）和 7 名无 CAD 患者（1.1%）在 30 天内发生心脏死亡或 MI（P<.001）。已知 CAD 患者的 30 天心脏死亡或 MI 的阴性预测值为 96.6%（95%CI，92.8%-98.8%），无已知 CAD 患者为 98.9%（95%CI，97.8%-99.6%）（P=.04）。
在已知 CAD 患者中，ESC 0/1 小时 hs-cTnT 算法无法安全排除 30 天心脏死亡或 MI。这表明如果在已知 CAD 患者中使用该算法，临床医生应谨慎。无 CAD 患者的阴性预测值显著较高，但仍低于 99%。
