Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital, P.-List-Str. 13, 04103 Leipzig, Germany.
Institute of Medical Informatics, Statistics and Epidemiology, University Leipzig, Germany.
Eur Heart J. 2021 Jun 21;42(24):2344-2352. doi: 10.1093/eurheartj/ehab110.
Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) still reaches excessively high mortality rates. This analysis is aimed to develop a new easily applicable biomarker-based risk score.
A biomarker-based risk score for 30-day mortality was developed from 458 patients with CS complicating AMI included in the randomized CULPRIT-SHOCK trial. The selection of relevant predictors and the coefficient estimation for the prognostic model were performed by a penalized multivariate logistic regression analysis. Validation was performed internally, internally externally as well as externally in 163 patients with CS included in the randomized IABP-SHOCK II trial. Blood samples were obtained at randomization. The two trials are registered with ClinicalTrials.gov (NCT01927549 and NCT00491036), are closed to new participants, and follow-up is completed. Out of 58 candidate variables, the four strongest predictors for 30-day mortality were included in the CLIP score (cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide). The score was well calibrated and yielded high c-statistics of 0.82 [95% confidence interval (CI) 0.78-0.86] in internal validation, 0.82 (95% CI 0.75-0.89) in internal-external (temporal) validation, and 0.73 (95% CI 0.65-0.81) in external validation. Notably, it outperformed the Simplified Acute Physiology Score II and IABP-SHOCK II risk score in prognostication (0.83 vs 0.62; P < 0.001 and 0.83 vs. 0.76; P = 0.03, respectively).
A biomarker-only score for 30-day mortality risk stratification in infarct-related CS was developed, extensively validated and calibrated in a prospective cohort of contemporary patients with CS after AMI. The CLIP score outperformed other clinical scores and may be useful as an early decision tool in CS.
急性心肌梗死（AMI）并发心源性休克（CS）的死亡率仍然过高。本分析旨在开发一种新的易于应用的基于生物标志物的风险评分。
从随机 CULPRIT-SHOCK 试验中纳入的 458 例 CS 合并 AMI 患者中，建立了 30 天死亡率的基于生物标志物的风险评分。通过惩罚性多变量逻辑回归分析选择相关预测因子并估算预测模型的系数。在随机 IABP-SHOCK II 试验中纳入的 163 例 CS 患者中进行了内部、内部外部和外部验证。在随机分组时采集血样。这两项试验均在 ClinicalTrials.gov 注册（NCT01927549 和 NCT00491036），已不再招募新的参与者，且随访已完成。在 58 个候选变量中，对 30 天死亡率有最强预测作用的四个指标被纳入 CLIP 评分（胱抑素 C、乳酸、白细胞介素-6 和 N 末端 B 型利钠肽前体）。该评分具有良好的校准度，内部验证的 C 统计量为 0.82[95%置信区间（CI）0.78-0.86]，内部-外部（时间）验证为 0.82（95%CI 0.75-0.89），外部验证为 0.73（95%CI 0.65-0.81）。值得注意的是，它在预后方面优于简化急性生理学评分 II 和 IABP-SHOCK II 风险评分（0.83 比 0.62；P<0.001 和 0.83 比 0.76；P=0.03）。
在 AMI 后 CS 患者的前瞻性队列中，我们开发了一种新的基于生物标志物的 30 天死亡率风险分层评分，进行了广泛的验证和校准。CLIP 评分优于其他临床评分，可能作为 CS 的早期决策工具有用。
