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Diagnostic Performance of Novel Troponin Algorithms for the Rule-Out of Non-ST-Elevation Acute Coronary Syndrome
Clinical Chemistry ( IF 9.3 ) Pub Date : 2021-09-30 , DOI: 10.1093/clinchem/hvab225
Hilde L Tjora 1 , Ole-Thomas Steiro 2 , Jørund Langørgen 2 , Rune O Bjørneklett 1, 3 , Øyvind Skadberg 4 , Vernon V S Bonarjee 5 , Øistein R Mjelva 5 , Paul Collinson 6 , Torbjørn Omland 7, 8 , Kjell Vikenes 2, 9 , Kristin M Aakre 2, 9, 10
Affiliation  

Background The European Society of Cardiology (ESC) rule-out algorithms use cutoffs optimized for exclusion of non-ST elevation myocardial infarction (NSTEMI). We investigated these and several novel algorithms for the rule-out of non-ST elevation acute coronary syndrome (NSTE-ACS) including less urgent coronary ischemia. Method A total of 1504 unselected patients with suspected NSTE-ACS were included and divided into a derivation cohort (n = 988) and validation cohort (n = 516). The primary endpoint was the diagnostic performance to rule-out NSTEMI and unstable angina pectoris during index hospitalization. The secondary endpoint was combined MI, all-cause mortality (within 30 days) and urgent (24 h) revascularization. The ESC algorithms for high-sensitivity cardiac troponin T (hs-cTnT) and I (hs-cTnI) were compared to different novel low-baseline (limit of detection), low-delta (based on the assay analytical and biological variation), and 0–1-h and 0–3-h algorithms. Results The prevalence of NSTE-ACS was 24.8%, 60.0% had noncardiac chest pain, and 15.2% other diseases. The 0–1/0–3-h algorithms had superior clinical sensitivity for the primary endpoint compared to the ESC algorithm (validation cohort); hs-cTnT: 95% vs 63%, and hs-cTnI: 87% vs 64%, respectively. Regarding the secondary endpoint, the algorithms had similar clinical sensitivity (100% vs 94%–96%) but lower clinical specificity (41%–19%) compared to the ESC algorithms (77%–74%). The rule-out rates decreased by a factor of 2–4. Conclusion Low concentration/low-delta troponin algorithms improve the clinical sensitivity for a combined endpoint of NSTEMI and unstable angina pectoris, with the cost of a substantial reduction in total rule-out rate. There was no clear benefit compared to ESC for diagnosing high-risk events.

中文翻译:

新型肌钙蛋白算法排除非 ST 段抬高急性冠状动脉综合征的诊断性能

背景 欧洲心脏病学会 (ESC) 排除算法使用为排除非 ST 段抬高心肌梗死 (NSTEMI) 而优化的截止值。我们研究了这些和几种新的排除非 ST 段抬高急性冠状动脉综合征 (NSTE-ACS) 的算法,包括不太紧急的冠状动脉缺血。方法 共纳入 1504 例未选择的疑似 NSTE-ACS 患者,并分为推导队列(n = 988)和验证队列(n = 516)。主要终点是在住院期间排除 NSTEMI 和不稳定型心绞痛的诊断性能。次要终点是心肌梗死、全因死亡率(30 天内)和紧急(24 小时)血运重建。将高灵敏度心肌肌钙蛋白 T (hs-cTnT) 和 I (hs-cTnI) 的 ESC 算法与不同的新型低基线(检测限)、低增量(基于测定分析和生物学变异)进行比较,和 0-1-h 和 0-3-h 算法。结果NSTE-ACS的患病率为24.8%,60.0%为非心源性胸痛,15.2%为其他疾病。与 ESC 算法(验证队列)相比,0-1/0-3-h 算法对主要终点具有更高的临床敏感性;hs-cTnT:95% 对 63%,hs-cTnI:87% 对 64%。关于次要终点,与 ESC 算法 (77%-74%) 相比,算法具有相似的临床敏感性 (100% 对 94%–96%),但临床特异性较低 (41%–19%)。排除率下降了 2-4 倍。结论 低浓度/低 delta 肌钙蛋白算法提高了 NSTEMI 和不稳定型心绞痛联合终点的临床敏感性,但总排除率显着降低。与 ESC 相比,在诊断高危事件方面没有明显的优势。
更新日期:2021-09-30
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