Numasawa Yohei, Kohsaka Shun, Ueda Ikuko, Miyata Hiroaki, Sawano Mitsuaki, Kawamura Akio, Noma Shigetaka, Suzuki Masahiro, Nakagawa Susumu, Momiyama Yukihiko, Fukuda Keiichi
Department of Cardiology, Ashikaga Red Cross Hospital, Tochigi, Japan.
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
J Cardiol. 2017 Jan;69(1):272-279. doi: 10.1016/j.jjcc.2016.05.003. Epub 2016 Jun 4.
Bleeding complications remain one of the most important challenges in percutaneous coronary intervention (PCI), particularly in Asians who are known to be vulnerable to the use of antiplatelets or anticoagulants. However, the incidence and predictors of bleeding complications after PCI have not been thoroughly investigated in Japan.
We studied 13,075 consecutive patients in a Japanese multicenter PCI registry (Japan Cardiovascular Database - Keio interhospital Cardiovascular Study: JCD-KiCS) from September 2008 to March 2014. Multivariate logistic regression analysis was performed to investigate independent predictors of bleeding complications, and to create three risk prediction models for bleeding events. Model 1 included patients' characteristics alone. In model 2, we added patients' clinical presentation. Model 3 included covariates in model 2 along with angiographic and technical factors. Model discrimination was assessed using the area under the receiver operating curve (AUC).
Overall, bleeding complications, according to the pre-specified US National Cardiovascular Data Registry criteria, were observed in 402 patients (3.1%). Independent predictors of bleeding complications included age, female gender, previous PCI, previous heart failure, hemodialysis (variables included in model 1), ST-elevation and non-ST-elevation myocardial infarction, cardiogenic shock (added in model 2), transradial intervention, use of intra-aortic balloon pumping or a rotablator, and PCI for chronic total occlusion (added in model 3). Above all, previous PCI and transradial intervention were inverse predictors of bleeding. The predictability of the risk models improved as the number of variables increased, with AUC of 0.667, 0.747, and 0.791 for models 1, 2, and 3, respectively.
The incidence of bleeding complications among Japanese PCI patients was approximately 3% in standard nomenclature, which is equivalent to that of other international registries. Patients' characteristics, clinical presentation, and angiographic and technical factors all independently contributed to its prediction.
出血并发症仍然是经皮冠状动脉介入治疗(PCI)中最重要的挑战之一,尤其是在已知易受抗血小板或抗凝药物影响的亚洲人群中。然而,在日本,PCI术后出血并发症的发生率和预测因素尚未得到充分研究。
我们研究了2008年9月至2014年3月在日本多中心PCI注册研究(日本心血管数据库 - 庆应义塾大学医院间心血管研究:JCD - KiCS)中连续入选的13075例患者。进行多因素逻辑回归分析以研究出血并发症的独立预测因素,并创建三个出血事件风险预测模型。模型1仅包括患者特征。在模型2中,我们增加了患者的临床表现。模型3在模型2的基础上纳入了血管造影和技术因素。使用受试者工作特征曲线下面积(AUC)评估模型判别能力。
总体而言,根据预先指定的美国国家心血管数据注册研究标准,402例患者(3.1%)出现出血并发症。出血并发症的独立预测因素包括年龄、女性、既往PCI史(PCI)、既往心力衰竭、血液透析(模型1中的变量)、ST段抬高型和非ST段抬高型心肌梗死、心源性休克(模型2中新增)、经桡动脉介入治疗、使用主动脉内球囊反搏或旋磨术,以及慢性完全闭塞病变的PCI治疗(模型3中新增)。最重要的是,既往PCI史和经桡动脉介入治疗是出血的反向预测因素。随着变量数量的增加,风险模型的预测能力提高,模型1、2和3的AUC分别为0.667、0.747和0.791。
按照标准命名法,日本PCI患者出血并发症的发生率约为3%,与其他国际注册研究相当。患者特征、临床表现以及血管造影和技术因素均独立地有助于对其进行预测。