急性冠状动脉综合征患者经皮冠状动脉介入术后出血情况分析

Bleeding complications after percutaneous coronary intervention in patients with acute coronary syndrome

目的分析急性冠状动脉综合征（ACS）经皮冠状动脉介入（PCI）术后出血情况。方法回顾性分析2003年1月至2014年12月来自11个国家16个临床中心的18077例行PCI的ACS患者的临床资料。根据是否出现出血事件，将患者分为出血组（558例）和非出血组（17519例），比较2组患者的基本临床特征、手术情况及生化指标。分析ACS患者PCI术后出血相关情况。结果马其顿中心数据因关键变量缺失过多而被排除患者2676例，故最终纳入10个国家15个中心15401例ACS患者。排除缺失数据，本研究共有12910例患者收集到出血部位的数据，409例患者存在出血事件。胃肠道是最常见出血部位，占48．7％（199／409），颅内出血占7．6％（31／409）。Logistic逐步回归方法多因素分析显示，既往出血病史、高血压病史是术后1年内消化道出血的危险因素。排除马其顿中心数据（2676例）与Cox回归模型和倾向性评分调整再排除5972例，剩余9429例作分层分析。根据是否联用质子泵抑制剂（PPI），将出院应用氯吡格雷生存患者8942例分为氯吡格雷联合应用PPI组（4814例）和氯吡格雷未联合应用PPI组（4126例）；将出院应用替格瑞洛生存患者489例分为替格瑞洛联合应用PPI组（351例）和替格瑞洛未联合应用PPI组（138例）。Kaplan-Meier法分析显示氯吡格雷联合应用PPI组1年出血事件发生率明显高于氯吡格雷未联合应用PPI组，差异有统计学意义（P=0．004）；替格瑞洛联合应用PPI组1年出血事件发生率与替格瑞洛未联合应用PPI组比较，差异无统计学意义（P=0．573）。结论ACS患者PCI术后最常见的出血部位为消化道，PPI与替格瑞洛联合应用在胃肠道出血风险较高患者中适用。

Objective To analyze the occurrence of bleeding complications after percutaneous coronal7 intervention（PCI） in patients with acute coronary syndrome（ACS）. Methods Totally 18 077 patients with ACS who had PCI from January 2003 to December 2014 in 16 clinical centers fronl 11 countries were retrospectively analyzed; 558 patients had bleeding complications （bleeding group）and 17 519 cases without bleeding were included in non-bleeding group. Clinical features, operative notes and biochemical indicators were analyzed. Results Totally 15 401 cases in 15 centers from 10 countries were finally included（2 676 cases from Macedonia center were excluded due to lack of key variables） ; 12 910 cases had complete follow-up data; bleeding events occurred in 409 cases; gastrointestinal tract bleeding accounted for 48.7% （199/409） and intracranial bleeding accounted for 7.6% （31/409）. Multivariate logistic regression analysis showed that previous bleeding history and hypertension history are risk factors of 1 year gastrointestinal tract bleeding. Based on Cox regression model and propensity score, 9 429 cases were included for stratified analysis. After discharge, 4 126 patients had elopidogrel and 4 814 patients had clopidogrel combined with proton pump inhibitors （PPI） ; 138 patients had ticagrelor and 351 patients had ticagrelor combined with PPI. Kaplan-Meier analysis showed that the 1 year incidence of bleeding in clopidogrel combined with PPI group was significantly higher than that in clopidogrel group （ P = 0. 004 ） ; there was no significant difference of incidence of bleeding between ticagrelor combined with PPI group and ticagrelor group（P = 0. 573）. Conclusion The most common bleeding complication is gastrointestinal bleeding in ACS patient after PCI; ticagrelor combined with PPI is reasonable for patients with high risk of gastrointestinal bleeding.