Department of Cardiology, Klinikum Worms, Germany
Department of Cardiology, St. Marien-Hospital Oberhausen, Oberhausen, Germany
J Cardiovasc Pharmacol. 2013 Dec;62(6):507-11. doi: 10.1097/FJC.0000000000000005.
Bleeding complications are associated with an adverse outcome after a percutaneous coronary intervention (PCI) is performed. Traditional risk factors for bleeding complications are age, gender, underweight, hypertension, and renal impairment. The aim of our study was to identify the independent predictors of bleeding complications in patients undergoing a PCI with concomitant treatment with bivalirudin.
Between January 2005 and June 2006, a total of 3799 patients, undergoing a planned or urgent PCI with concomitant bivalirudin treatment, were prospectively enrolled in the ImproveR registry. One hundred two centers out of 12 European countries participated in the ImproveR registry. In this analysis, we report the incidence of bleeding complications in subgroups to be at a high risk for developing bleeding complications. A multivariate logistic regression model was performed to identify the independent predictors of bleeding complications.
Major bleeding complications occurred in 1.7% of the patients. The highest incidence of major bleeding complications was observed in the subgroup with a sheath size ≥7F (4.3%), heparin use after the PCI (3.5%), and additional use of GP IIb/IIIa inhibitors (3.3%). The multivariate regression analysis revealed female gender [odds ratio (OR), 2.3; 95% confidence interval (CI), 1.4-3.8], heparin after the PCI (OR, 3.1; 95% CI, 1.9-5.1), and sheath size ≥7F (OR, 3.1; 95% CI, 1.8-5.4) as the independent predictors of bleeding.
The rate of occurrence of bleeding complications in patients undergoing a PCI with concomitant use of bivalirudin is low in clinical practice. Female gender and procedural factors, such as sheath size and heparin after PCI, were associated with an increase in bleeding complications, whereas other traditional risk factors associated with bleeding, such as age, diabetes mellitus, and renal impairment, had no impact.
经皮冠状动脉介入治疗（PCI）后出血并发症与不良预后相关。出血并发症的传统危险因素包括年龄、性别、体重不足、高血压和肾功能不全。本研究旨在确定同时接受比伐卢定治疗的 PCI 患者出血并发症的独立预测因素。
2005 年 1 月至 2006 年 6 月，共前瞻性纳入 3799 例计划或紧急行 PCI 且同时接受比伐卢定治疗的患者入组 ImproveR 登记研究。来自 12 个欧洲国家的 102 个中心参与了 ImproveR 登记研究。在本分析中，我们报告了出血并发症发生率较高的亚组患者的出血并发症发生率。采用多变量逻辑回归模型确定出血并发症的独立预测因素。
1.7%的患者发生主要出血并发症。鞘管大小≥7F（4.3%）、PCI 后使用肝素（3.5%）和额外使用 GP IIb/IIIa 抑制剂（3.3%）的患者亚组出血并发症发生率最高。多变量回归分析显示，女性（比值比 [OR]，2.3；95%置信区间 [CI]，1.4-3.8）、PCI 后使用肝素（OR，3.1；95% CI，1.9-5.1）和鞘管大小≥7F（OR，3.1；95% CI，1.8-5.4）是出血的独立预测因素。
在临床实践中，同时使用比伐卢定的 PCI 患者出血并发症发生率较低。女性性别和手术相关因素（如鞘管大小和 PCI 后肝素的使用）与出血并发症增加相关，而与出血相关的其他传统危险因素（如年龄、糖尿病和肾功能不全）则无影响。
