Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Medical Faculty, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany.
Clinic for Cardiovascular Surgery, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
Clin Res Cardiol. 2020 Feb;109(2):235-245. doi: 10.1007/s00392-019-01506-x. Epub 2019 Jun 24.
The National Cardiovascular Data Registry (NCDR) risk scores for mortality, bleeding and acute kidney injury (AKI) are accurate outcome predictors of coronary catheterization procedures in North American populations. However, their application in German clinical practice remained elusive and we thus aimed to verify their use.
NCDR scores for mortality, bleeding and AKI and corresponding clinical outcomes were retrospectively assessed in patients undergoing catheterization for ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) or for elective coronary procedures at a German Heart Center from 2014 to 2017. Risk model performance was assessed using receiver-operating-characteristic curves (discrimination) and graphical analysis/logistic regression (calibration).
A total of 1637 patients were included, procedures were performed for STEMI (565 patients, 34.5%), NSTEMI (572 patients, 34.9%) and elective purposes (500 patients, 30.5%); 6% (13% of STEMI and 5% of NSTEMI patients) presented in cardiogenic shock and 3% with resuscitated cardiac arrest. Radial access was used in 38% of procedures and cross-over was necessary in 5%; PCI was performed in 60% of procedures. In-hospital mortality was 6.3% (STEMI 14.5%; NSTEMI 3.7%; elective 0%) and major bleedings occurred in 5.6% (STEMI 10.6%; NSTEMI 5.4%; elective 0.2%); AKI was detected in 18.1% of patients (STEMI 23.7%; NSTEMI 27.3%; elective 1.4%), amounting to KDIGO stage I/II/III in 11.5%/3.5%/3.2%. NCDR risk models discriminated very well for mortality [AUC 0.93 with 95% confidence interval (CI) 0.91-0.95] and well for major bleeding (AUC 0.82, CI 0.78-0.86) and any AKI (AUC 0.83, CI 0.81-0.86). Discrimination in the subgroup of patients with PCI was comparable (mortality: AUC 0.90; major bleeding: AUC 0.78; any AKI: AUC 0.79). However, calibration showed considerable underestimation of mortality and AKI in high-risk patients, while major bleeding was consistently overestimated (Hosmer-Lemeshow p < 0.02 for all outcomes).
The NCDR risk models showed excellent performance in discriminating high-risk from low-risk patients in contemporary German interventional cardiology. Model calibration for adverse event probability prediction, however, is limited and demands recalibration, especially in high-risk patients.
国家心血管数据登记处(NCDR)的死亡率、出血和急性肾损伤(AKI)风险评分是北美人群冠状动脉介入治疗的准确预后预测指标。然而,它们在德国临床实践中的应用仍不明确,因此我们旨在验证其使用。
回顾性评估了 2014 年至 2017 年期间在德国心脏中心接受经皮冠状动脉介入治疗(STEMI)、非 ST 段抬高型心肌梗死(NSTEMI)或择期冠状动脉介入治疗的患者的 NCDR 死亡率、出血和 AKI 风险评分以及相应的临床结局。使用接受者操作特征曲线(鉴别)和图形分析/逻辑回归(校准)评估风险模型性能。
共纳入 1637 例患者,其中行 STEMI 介入治疗(565 例,34.5%)、NSTEMI(572 例,34.9%)和择期介入治疗(500 例,30.5%);6%(STEMI 患者的 13%,NSTEMI 患者的 5%)出现心源性休克,3%出现复苏性心脏骤停。38%的患者采用桡动脉入路,5%的患者需要交叉;60%的患者接受了经皮冠状动脉介入治疗。院内死亡率为 6.3%(STEMI 患者为 14.5%,NSTEMI 患者为 3.7%,择期患者为 0%),大出血发生率为 5.6%(STEMI 患者为 10.6%,NSTEMI 患者为 5.4%,择期患者为 0.2%),18.1%的患者发生 AKI(STEMI 患者为 23.7%,NSTEMI 患者为 27.3%,择期患者为 1.4%),其中 KDIGO 分期 I/II/III 期分别为 11.5%、3.5%和 3.2%。NCDR 风险模型对死亡率的鉴别能力非常好[AUC 0.93,95%置信区间(CI)0.91-0.95],对大出血(AUC 0.82,CI 0.78-0.86)和任何 AKI(AUC 0.83,CI 0.81-0.86)的鉴别能力也较好。在接受经皮冠状动脉介入治疗的患者亚组中,鉴别能力相当(死亡率:AUC 0.90;大出血:AUC 0.78;任何 AKI:AUC 0.79)。然而,校准显示,在高危患者中,死亡率和 AKI 的预测值存在明显低估,而大出血的预测值则持续高估(所有结局的 Hosmer-Lemeshow p 值均<0.02)。
NCDR 风险模型在鉴别当代德国介入心脏病学中的高危和低危患者方面表现出优异的性能。然而,不良事件概率预测的模型校准存在局限性,需要重新校准,尤其是在高危患者中。