学术研究联盟针对高出血风险所提出的高出血风险标准及定义的验证
Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk.
作者信息
Corpataux Noé, Spirito Alessandro, Gragnano Felice, Vaisnora Lukas, Galea Roberto, Svab Stefano, Gargiulo Giuseppe, Zanchin Thomas, Zanchin Christian, Siontis George C M, Praz Fabien, Lanz Jonas, Hunziker Lukas, Stortecky Stefan, Pilgrim Thomas, Räber Lorenz, Capodanno Davide, Urban Philip, Pocock Stuart, Heg Dik, Windecker Stephan, Valgimigli Marco
机构信息
Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy.
出版信息
Eur Heart J. 2020 Oct 7;41(38):3743-3749. doi: 10.1093/eurheartj/ehaa671.
AIMS
To validate the set of clinical and biochemical criteria proposed by consensus by the Academic Research Consortium (ARC) for High Bleeding Risk (HBR) for the identification of HBR patients. These criteria were categorized into major and minor, if expected to carry in isolation, respectively, ≥4% and <4% Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding risk within 1-year after percutaneous coronary intervention (PCI). High bleeding risk patients are those meeting at least 1 major or 2 minor criteria.
METHODS AND RESULTS
All patients undergoing PCI at Bern University Hospital, between February 2009 and September 2018 were prospectively entered into the Bern PCI Registry (NCT02241291). Age, haemoglobin, platelet count, creatinine, and use of oral anticoagulation were prospectively collected, while the remaining HBR criteria except for planned surgery were retrospectively adjudicated. A total of 16 580 participants with complete ARC-HBR criteria were included. After assigning 1 point to each major and 0.5 point to each minor criterion, we observed for every 0.5 score increase a step-wise augmentation of BARC 3 or 5 bleeding rates at 1 year ranging from 1.90% among patients fulfilling no criterion, through 4.01%, 5.98%, 7.42%, 8.60%, 12.21%, 12.29%, and 17.64%. All major and five out of six minor criteria, conferred in isolation a risk for BARC 3 or 5 bleeding at 1 year exceeding 4% at the upper limit of the 95% confidence intervals.
CONCLUSION
All major and the majority of minor ARC-HBR criteria identify in isolation patients at HBR.
目的
验证学术研究联盟（ARC）就高出血风险（HBR）达成共识所提出的临床和生化标准集，以识别HBR患者。这些标准分为主要标准和次要标准，若单独存在，预计在经皮冠状动脉介入治疗（PCI）后1年内分别具有≥4%和<4%的出血学术研究联盟（BARC）3型或5型出血风险。高出血风险患者是指符合至少1项主要标准或2项次要标准的患者。
方法与结果
2009年2月至2018年9月在伯尔尼大学医院接受PCI的所有患者均前瞻性纳入伯尔尼PCI注册研究（NCT02241291）。前瞻性收集年龄、血红蛋白、血小板计数、肌酐和口服抗凝药的使用情况，而除计划手术外的其余HBR标准则进行回顾性判定。共纳入16580名具有完整ARC-HBR标准的参与者。在给每个主要标准赋1分、每个次要标准赋0.5分后，我们观察到每增加0.5分，1年时BARC 3型或5型出血率呈逐步上升，从无标准符合的患者中的1.90%，依次为4.01%、5.98%、7.42%、8.60%、12.21%、12.29%和17.64%。所有主要标准和六项次要标准中的五项，单独存在时在1年时导致BARC 3型或5型出血的风险在95%置信区间上限超过4%。
结论
所有主要ARC-HBR标准和大多数次要ARC-HBR标准单独存在时均可识别HBR患者。
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