简约型与广泛型出血评分：经皮冠状动脉介入治疗后我们能否简化风险分层并通过降低抗血小板策略强度来减少出血事件？
Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy?
作者信息
Woelders Eva Christine Ida, Onuma Yoshinobu, Ninomiya Kai, O'Leary Neil, Damman Peter, Peeters Denise Adriana Maria, Hof Arnoud Willem Johannes van 't, Valgimigli Marco, Vranckx Pascal, Windecker Stephan, Serruys Patrick Washington J C, van Geuns Robert-Jan Matthijs
机构信息
Cardiology, Radboudumc, Nijmegen, The Netherlands.
Department of Cardiology, University of Galway, Galway, Ireland.
出版信息
Open Heart. 2025 Jan 28;12(1):e003083. doi: 10.1136/openhrt-2024-003083.
BACKGROUND AND AIMS
Due to the multitude of risk factors outlined in the guidelines, personalised dual antiplatelet therapy (DAPT) guidance after percutaneous coronary intervention (PCI) is complex. A simplified method was created to facilitate the use of risk stratification. We aimed to compare the predictive and prognostic value of the 'Zuidoost Nederland Hart Registratie' (ZON-HR) classification for bleeding risk with the PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent DAPT (PRECISE-DAPT) score and to determine the effect of ticagrelor monotherapy versus DAPT in patients with or without high bleeding risk (HBR).
METHODS
A post hoc analysis of the GLOBAL LEADERS trial was performed to compare the predictive value of the ZON-HR classification with the PRECISE-DAPT score. Also, the outcomes stratified by either method were compared and the interaction of HBR on the treatment effect was determined.
RESULTS
The required parameters for the ZON-HR classification (3.7% HBR) and PRECISE-DAPT score (16.6% HBR) were available in 99.9% and 93% of the patients, respectively. The ZON-HR classification had a lower sensitivity (0.09 vs 0.26) and a higher specificity (0.97 vs 0.84), positive predictive value (0.13 vs 0.08) and accuracy (0.92 vs 0.82). Regression analysis showed that both methods predicted hazard for bleeding risk with HRs of 1.87 (95% CI: 1.59 to 2.18) and 2.67 (95% CI: 2.10 to 3.41) for the PRECISE-DAPT score and ZON-HR classification, respectively. The omission of aspirin reduced bleeding events only in acute coronary syndrome (ACS) patients without HBR (HR: 0.74, 95% CI: 0.61 to 0.90, p value for interaction of HBR: 0.04).
CONCLUSIONS
Stratification for bleeding risk according to the ZON-HR classification was feasible in almost all patients and showed to be more conservative than the PRECISE-DAPT score with a consistent prognostic accuracy. The benefit of aspirin omission was the largest in ACS patients without HBR.
TRIAL REGISTRATION NUMBER
NCT01813435.
背景与目的
由于指南中列出的众多风险因素，经皮冠状动脉介入治疗（PCI）后个性化双联抗血小板治疗（DAPT）的指导较为复杂。创建了一种简化方法以促进风险分层的应用。我们旨在比较“荷兰东南部心脏注册研究”（ZON-HR）出血风险分类与预测支架植入及后续DAPT患者出血并发症（PRECISE-DAPT）评分的预测价值和预后价值，并确定替格瑞洛单药治疗与DAPT在有或无高出血风险（HBR）患者中的效果。
方法
对GLOBAL LEADERS试验进行事后分析，以比较ZON-HR分类与PRECISE-DAPT评分的预测价值。此外，比较两种方法分层后的结果，并确定HBR对治疗效果的相互作用。
结果
分别有99.9%和93%的患者可获得ZON-HR分类（HBR为3.7%）和PRECISE-DAPT评分（HBR为16.6%）所需的参数。ZON-HR分类的敏感性较低（0.09对0.26），特异性较高（0.97对0.84），阳性预测值（0.13对0.08）和准确性（0.92对0.82）。回归分析显示，两种方法均能预测出血风险，PRECISE-DAPT评分和ZON-HR分类的风险比分别为1.87（95%CI：1.59至2.18）和2.67（95%CI：2.10至3.41）。仅在无HBR的急性冠状动脉综合征（ACS）患者中，停用阿司匹林可减少出血事件（风险比：0.74，95%CI：0.61至0.90，HBR相互作用的p值为0.04）。
结论
根据ZON-HR分类进行出血风险分层在几乎所有患者中都是可行的，并且显示出比PRECISE-DAPT评分更保守，且预后准确性一致。在无HBR的ACS患者中，停用阿司匹林的获益最大。
试验注册号
NCT01813435。
Zotero 插件