Objective: To compare the clinical characteristics and long-term prognosis between male and female patients with premature coronary artery disease (PCAD) post coronary intervention, and analyse the risk factors of major adverse cardio-cerebrovascular events (MACCE) and bleeding events. Methods: This was a prospective single-center observational study. From January 2013 to December 2013, 4 744 patients diagnosed as PCAD and treated with percutaneous coronary intervention (PCI) in Fuwai Hospital were enrolled. The general clinical data, laboratory results and interventional treatment data of all patients were collected, and patients were followed up for 2 years after PCI and the incidence of events including MACCE and bleeding was analyzed. The baseline data and clinical events of PCAD patients of different genders were compared. Survival curves were estimated by Kaplan-Meier method. Univariate and multivariate Cox regression were used to analyze whether gender was an influencing factor of different clinical events of PCAD patients within 2 years after PCI, and other relevant influencing factors of MACCE and bleeding events. Results: Among the 4 744 PCAD patients included, there were 3 390 (71.5%) male aged (47.0±5.4) years old and 1 354 (28.5%) female aged (57.0±5.8) years old. Compared with female patients, male patients had higher body mass index, higher proportion of hyperlipidemia, smoking, myocardial infarction, previous PCI, preoperative estimated glomerular filtration rate, ST-segment elevation myocardial infarction, radial artery approach, intravenous ultrasound use and chronic occlusive lesions (all P<0.05). Age, left ventricular ejection fraction, prevalence of hypertension, diabetes mellitus, past stroke history, non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and the use of calcium channel blockers were lower in male patients than in female patients (all P<0.05). The 2-year follow-up results showed that the incidence of BARC type 1 hemorrhage was significantly higher in female patients than in male patients (6.9%(92/1 343) vs. 3.7%(126/3 378), P<0.001); however, the incidence of MACCE, all-cause death, cardiac death, recurrent myocardial infarction, revascularization (target vessel revascularization and target lesion revascularization), stent thrombosis, stroke and BARC type 2-5 hemorrhage were similar between the two groups (all P>0.05). Multivariate Cox regression analysis showed that gender was an independent risk factor for BARC type 1 bleeding in PCAD patients (HR=2.180, 95%CI 1.392-3.416, P<0.001), but it was not an independent risk factor for MACCE and BARC type 2-5 bleeding(all P>0.05). Hyperlipidemia, preoperative SYNTAX score, multivessel lesions and NSTE-ACS were the independent risk factors for MACCE in PCAD patients with PCI (the HRs(95%CI) were 1.289(1.052-1.580), 1.030(1.019-1.042), 1.758(1.365-2.264), 1.264(1.040-1.537), respectively); gender (HR=1.579, 95%CI 1.085-2.297, P=0.017), hyperlipidemia (HR=1.305, 95%CI 1.005-1.695, P=0.046), anticoagulant drugs including low molecular weight heparin (HR=1.321, 95%CI 1.002-1.741, P=0.048) or sulfonate(HR=1.659, 95%CI 1.198-2.298, P=0.002) were the independent risk factors for bleeding events. Conclusions: There are differences in clinical and coronary artery lesion characteristics between different genders in patients with PCAD. The incidence of minor bleeding is significantly higher in female PCAD patients than in male PCAD patients. Hyperlipidemia, preoperative SYNTAX score, multivessel lesions and NSTE-ACS are the independent risk factors for MACCE, and gender, hyperlipidemia, anticoagulant drugs including low molecular weight heparin or sulfonate are the independent risk factors for bleeding events in patients with PCAD.
目的: 探讨经皮冠状动脉介入治疗(PCI)术后不同性别早发冠心病(PCAD)患者的临床特点及远期预后,并分析PCAD患者2年主要不良心脑血管事件(MACCE)和出血事件的危险因素。 方法: 该研究为前瞻性单中心观察性研究,连续纳入2013年1月至12月在阜外医院诊断为PCAD并行PCI的患者4 744例。收集所有患者的一般临床资料、实验室检查结果和介入治疗资料,并随访术后2年内MACCE、出血等临床事件的发生情况。对比不同性别PCAD患者的基线资料及临床事件发生情况,采用Kaplan-Meier生存分析比较各临床事件发生率在两性间的差别,采用单因素及多因素Cox回归分析性别是否为PCAD患者PCI术后2年临床事件的影响因素,并进一步探讨MACCE及出血事件的影响因素。 结果: 纳入研究的4 744例患者中,男性3 390例(71.5%),年龄(47.0±5.4)岁;女性1 354例(28.5%),年龄(57.0±5.8)岁。与女性患者比较,男性患者的体重指数、高脂血症比例、吸烟比例、心肌梗死比例、既往PCI比例、术前肾小球滤过率、ST段抬高型心肌梗死比例以及采用桡动脉途径、使用血管内超声、慢性闭塞病变的比例均较高(P均<0.05),而年龄、左心室射血分数、高血压比例、糖尿病比例、既往卒中史比例、非ST段抬高型急性冠状动脉综合征(NSTE-ACS)以及使用钙通道阻滞剂的比例均较低(P均<0.05)。2年随访结果显示,女性患者BARC 1型出血的发生率明显高于男性[6.9%(92/1 343)比3.7%(126/3 378),P<0.001],而MACCE、全因死亡、心原性死亡、再发心肌梗死、血运重建(靶血管血运重建和靶病变血运重建)、支架内血栓、卒中以及BARC 2~5型出血的发生率两组间差异无统计学意义(P均>0.05)。多因素Cox回归分析显示,性别是PCAD患者PCI术后2年随访期间BARC 1型小出血事件的独立危险因素(HR=2.180,95%CI 1.392~3.416,P<0.001),但不是MACCE和BARC 2~5型出血的独立危险因素(P均>0.05)。PCAD患者PCI术后2年随访期间MACCE的独立危险因素为高脂血症(HR=1.289,95%CI 1.052~1.580,P=0.014)、术前SYNTAX评分(HR=1.030,95%CI 1.019~1.042,P<0.001)、多支病变(HR=1.758,95%CI 1.365~2.264,P<0.001)、NSTE-ACS(HR=1.264,95%CI 1.040~1.537,P=0.019);出血事件的独立危险因素有性别(HR=1.579,95%CI 1.085~2.297,P=0.017)、高脂血症(HR=1.305,95%CI 1.005~1.695,P=0.046)及使用低分子肝素(HR=1.321,95%CI 1.002~1.741,P=0.048)或磺达肝癸钠(HR=1.659,95%CI 1.198~2.298,P=0.002)等抗凝药物。 结论: 不同性别PCAD患者有各自的临床特点,女性PCAD患者PCI术后2年小出血的发生率高于男性患者。高脂血症、术前SYNTAX评分、多支病变、NSTE-ACS是PCAD患者PCI术后2年MACCE的独立危险因素,性别、高脂血症、使用低分子肝素或磺达肝癸钠是PCAD患者PCI术后2年出血事件的独立危险因素。.
Keywords: Coronary artery disease; Gender; Prognosis.