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?

IF 2.8 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Open Heart Pub Date : 2025-01-28 DOI:10.1136/openhrt-2024-003083
Eva Christine Ida Woelders, Yoshinobu Onuma, Kai Ninomiya, Neil O'Leary, Peter Damman, Denise Adriana Maria Peeters, Arnoud Willem Johannes van 't Hof, Marco Valgimigli, Pascal Vranckx, Stephan Windecker, Patrick Washington J C Serruys, Robert-Jan Matthijs van Geuns
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Abstract

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.

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简约性与广泛性出血评分:我们能否简化经皮冠状动脉介入治疗后的风险分层,并通过降低抗血小板策略来减少出血事件?
背景和目的:由于指南中列出的多种危险因素,经皮冠状动脉介入治疗(PCI)后的个体化双重抗血小板治疗(DAPT)指导是复杂的。为了便于使用风险分层,建立了一种简化的方法。我们的目的是比较“Zuidoost Nederland Hart Registratie”(ZON-HR)分类对出血风险的预测和预后价值,以及预测支架植入术患者的出血并发症和随后的DAPT (precision -DAPT)评分,并确定替格瑞洛单药治疗与DAPT在有或没有高出血风险(HBR)患者中的效果。方法:对GLOBAL LEADERS试验进行事后分析,比较ZON-HR分类与precision - dapt评分的预测价值。此外,比较两种方法的分层结果,并确定HBR对治疗效果的相互作用。结果:99.9%和93%的患者分别满足ZON-HR分级(3.7% HBR)和precision - dapt评分(16.6% HBR)所需参数。ZON-HR分类具有较低的敏感性(0.09 vs 0.26)和较高的特异性(0.97 vs 0.84)、阳性预测值(0.13 vs 0.08)和准确性(0.92 vs 0.82)。回归分析显示,两种方法预测出血风险的hr分别为1.87 (95% CI: 1.59 ~ 2.18)和2.67 (95% CI: 2.10 ~ 3.41), precision - dapt评分和ZON-HR分类。仅在没有HBR的急性冠脉综合征(ACS)患者中,不使用阿司匹林可减少出血事件(HR: 0.74, 95% CI: 0.61 ~ 0.90, HBR相互作用的p值:0.04)。结论:根据ZON-HR分级对出血风险进行分层在几乎所有患者中都是可行的,并且比precision - dapt评分更保守,预后准确性一致。在没有HBR的ACS患者中,省略阿司匹林的获益最大。试验注册号:NCT01813435。
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来源期刊
Open Heart
Open Heart CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
4.60
自引率
3.70%
发文量
145
审稿时长
20 weeks
期刊介绍: Open Heart is an online-only, open access cardiology journal that aims to be “open” in many ways: open access (free access for all readers), open peer review (unblinded peer review) and open data (data sharing is encouraged). The goal is to ensure maximum transparency and maximum impact on research progress and patient care. The journal is dedicated to publishing high quality, peer reviewed medical research in all disciplines and therapeutic areas of cardiovascular medicine. Research is published across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Opinionated discussions on controversial topics are welcomed. Open Heart aims to operate a fast submission and review process with continuous publication online, to ensure timely, up-to-date research is available worldwide. The journal adheres to a rigorous and transparent peer review process, and all articles go through a statistical assessment to ensure robustness of the analyses. Open Heart is an official journal of the British Cardiovascular Society.
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