Fresenius Medical Care Deutschland GmbH, Else-Kroener-Str. 1, 61352, Bad Homburg, Germany.
Fresenius Medical Care España, S.A, Tres Cantos, Madrid, Spain.
BMC Nephrol. 2023 Feb 15;24(1):35. doi: 10.1186/s12882-023-03069-6.
Vascular calcification is a major contributor to the high cardiac burden among hemodialysis patients. A novel in vitro T50-test, which determines calcification propensity of human serum, may identify patients at high risk for cardiovascular (CV) disease and mortality. We evaluated whether T50 predicts mortality and hospitalizations among an unselected cohort of hemodialysis patients.
This prospective clinical study included 776 incident and prevalent hemodialysis patients from 8 dialysis centers in Spain. T50 and fetuin-A were determined at Calciscon AG, all other clinical data were retrieved from the European Clinical Database. After their baseline T50 measurement, patients were followed for two years for the occurrence of all-cause mortality, CV-related mortality, all-cause and CV-related hospitalizations. Outcome assessment was performed with proportional subdistribution hazards regression modelling.
Patients who died during follow-up had a significantly lower T50 at baseline as compared to those who survived (269.6 vs. 287.7 min, p = 0.001). A cross-validated model (mean c statistic: 0.5767) identified T50 as a linear predictor of all-cause-mortality (subdistribution hazard ratio (per min): 0.9957, 95% CI [0.9933;0.9981]). T50 remained significant after inclusion of known predictors. There was no evidence for prediction of CV-related outcomes, but for all-cause hospitalizations (mean c statistic: 0.5284).
T50 was identified as an independent predictor of all-cause mortality among an unselected cohort of hemodialysis patients. However, the additional predictive value of T50 added to known mortality predictors was limited. Future studies are needed to assess the predictive value of T50 for CV-related events in unselected hemodialysis patients.
血管钙化是血液透析患者心脏负担高的主要原因之一。一种新的体外 T50 测试可以确定人血清的钙化倾向，从而识别出心血管疾病和死亡率高风险的患者。我们评估了 T50 是否可以预测未选择的血液透析患者的死亡率和住院率。
这是一项前瞻性临床研究，纳入了来自西班牙 8 家透析中心的 776 名新发病例和持续性血液透析患者。Calciscon AG 公司测定 T50 和胎球蛋白 A，所有其他临床数据均从欧洲临床数据库中检索。在基线 T50 测量后，对患者进行了两年的随访，以评估全因死亡率、心血管相关死亡率、全因和心血管相关住院率。使用比例亚分布风险回归模型进行结果评估。
随访期间死亡的患者与存活的患者相比，基线 T50 显著降低（269.6 分钟比 287.7 分钟，p=0.001）。经交叉验证的模型（平均 c 统计量：0.5767）确定 T50 是全因死亡率的线性预测因子（亚分布风险比（每增加 1 分钟）：0.9957，95%置信区间 [0.9933；0.9981]）。纳入已知预测因子后，T50 仍具有显著意义。没有证据表明 T50 可以预测心血管相关结局，但可以预测全因住院率（平均 c 统计量：0.5284）。
T50 是未选择的血液透析患者全因死亡率的独立预测因子。然而，T50 增加了已知的死亡率预测因子的预测价值有限。未来需要研究 T50 对未选择的血液透析患者心血管相关事件的预测价值。
