Franco Laura, Becattini Cecilia, Beyer-Westendorf Jan, Vanni Simone, Nitti Cinzia, Re Roberta, Manina Giorgia, Pomero Fulvio, Cappelli Roberto, Conti Alberto, Agnelli Giancarlo
Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia, Italy.
University Hospital, Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
J Thromb Haemost. 2020 Nov;18(11):2852-2860. doi: 10.1111/jth.15048. Epub 2020 Sep 11.
In patients on anticoagulant treatment, the major bleeding (MB) definition released by the International Society of Thrombosis and Haemostasis (ISTH) is widely accepted. However, this definition identifies MBs with highly variable short-term risk of death.
The study aims were to derive and validate a classification of ISTH-defined MBs for the risk of short-term death.
Consecutive patients admitted for ISTH-defined MB occurring while on treatment with oral anticoagulants were included in the study and divided into a derivation and a validation cohort. Death within 30 days was the primary study outcome.
Among 1077 patients with MB, 64/517 and 63/560 patients in the derivation and validation cohort died, respectively. In the derivation cohort, Glasgow coma scale (GCS) <14 and shock were predictors of death; critical site bleeding and hemoglobin decrease ≥2 g/dL, or transfusion ≥ 2 units were not. GCS <14 (hazard ratio [HR], 8.67; 95% confidence interval [CI], 3.93-19.13) was predictor of death in intracranial hemorrhage (ICH) and shock at admission (HR, 4.84; 95% CI, 2.01-11.70) and pericardial bleeding (HR, 11.37; 95% CI, 1.33-97.31) in non-ICH MBs. The predictive value of GCS <14 in ICH and shock and pericardial bleeding in non-ICH MBs was confirmed in the validation cohort. None of the patients with isolated ocular or articular bleeding died. A prognostic classification of ISTH-defined MBs for the risk of short-term death is proposed as "serious," "severe," and "life-threatening" (ICH with GCS <14 or non-ICH with shock) MBs.
According to our study, ISTH-defined MBs can be stratified for the risk of death within 30 days.
在接受抗凝治疗的患者中，国际血栓与止血学会（ISTH）发布的大出血（MB）定义被广泛接受。然而，该定义所确定的大出血患者短期死亡风险差异很大。
本研究旨在推导并验证一种针对ISTH定义的大出血患者短期死亡风险的分类方法。
本研究纳入了在接受口服抗凝治疗期间发生ISTH定义的大出血的连续入院患者，并将其分为推导队列和验证队列。30天内死亡是主要研究结局。
在1077例大出血患者中，推导队列和验证队列分别有64/517例和63/560例患者死亡。在推导队列中，格拉斯哥昏迷量表（GCS）<14分和休克是死亡的预测因素；关键部位出血、血红蛋白下降≥2g/dL或输血≥2单位则不是。GCS<14分（风险比[HR]，8.67；95%置信区间[CI]，3.93 - 19.13）是颅内出血（ICH）患者死亡的预测因素，入院时休克（HR，4.84；95%CI，2.01 - 11.70）和非ICH大出血患者心包出血（HR，11.37；95%CI，1.33 - 97.31）时也是死亡的预测因素。GCS<14分在ICH患者以及非ICH大出血患者休克和心包出血时的预测价值在验证队列中得到了证实。单纯眼部或关节出血的患者均未死亡。针对ISTH定义的大出血患者短期死亡风险，提出了一种预后分类，即“严重”、“重度”和“危及生命”（GCS<14分的ICH或伴有休克的非ICH）大出血。
根据我们的研究，ISTH定义的大出血患者可根据30天内的死亡风险进行分层。
