李洁,张梅

SYNTAX评分对接受PCI治疗的无保护左主干病变患者的预测价值

李洁1,2,张梅3

目的 研究SYNTAX评分(SxScore)和SYNTAXⅡ评分(SxScoreⅡ)对无保护左主干(ULMCA)冠心病患者接受经皮冠状动脉介入治疗(PCI)术后30个月的主要不良心脑血管事件(MACCE)的预测能力。方法 回顾性分析武警后勤学院附属医院心内科接受PCI治疗的209例ULMCA冠心病患者,通过电话、门诊和(或)再次入院随访患者PCI术后的MACCE,包括全因死亡、非致命性心肌梗死、靶血管血运重建、卒中及次要终点事件包括心源性死亡、支架内血栓。根据冠状动脉造影结果及临床特征计算SxScore和SxScoreⅡ,根据SxScore标准分为低分组≤22分,中分组23~32分,高分组≥33分,比较3组的临床资料,Cox回归评价两种评分系统对PCI术后MACCE的预测能力。结果 209例患者中,失访12例(5.7%),中位随访时间为30.2个月,56例(28.4%)观察到MACCE。SxScore低、中、高分组的MACCE发生率分别为19.0%,28.6%和44.4%。SxScoreⅡ低、中、高分组的MACCE发生率分别为12.8%、23.8%和45.5%。单因素分析结果显示SxScore、SxScoreⅡ高分值、高龄、合并糖尿病和低左室射血分数(LVEF)为MACCE的危险因子,多因素分析结果显示SxScore、SxScoreⅡ高分值仍为MACCE的独立危险因子。结论 SxScore 和SxScoreⅡ对冠状动脉ULMCA病变患者行PCI治疗后的MACCE均有预测作用。

血管成形术,经腔,经皮冠状动脉;冠状动脉疾病;无保护左主干;SxScore;SxScoreⅡ;主要不良心脑血管事件

2009年欧洲心血管病会议(European Society Congress,ESC)上公布了SYNTAX研究并提出了SYNTAX评分(SxScore)[1],即以冠状动脉病变的严重程度来进行危险分层以指导患者血运重建策略的选择。目前大量的国外相关研究已证实SxScore对于无保护左主干(unprotected left main coronary artery,ULMCA)患者经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)术后远期效果有预测价值并被国内指南采纳[2]。2013年Farooq等[3]公布了SYNTAX研究5年结果并提出了一个新的评分方法——SYNTAXⅡ评分(SxScoreⅡ)。SxScoreⅡ由原来的1个解剖变量增加为2个解剖变量和6个临床变量。国外有研究认为其预测作用优于SxScore,但相关研究较少[4]。本研究旨在探讨SxScore和 SxScoreⅡ对 ULMCA患者 PCI术后主要不良心脑血管事件(major adverse cardiac and cerebrovasculur events,MACCE)的预测能力。

1 对象与方法

1.1 研究对象 回顾性分析2009年6月—2012年1月在天津武警后勤学院附属医院心内科接受PCI治疗的ULMCA的冠心病患者。全部病例均符合ULMCA病变定义,同时不存在通畅的血管桥或自身右向左良好侧支循环。纳入标准:(1)心肌缺血导致的稳定型心绞痛、不稳定型心绞痛、非ST段抬高型心肌梗死、不典型胸痛或者无症状但有客观缺血证据者。(2)未经干预的原位病变。(3)冠脉造影左主干狭窄程度≥50%,无通畅的血管桥或侧支循环,可伴有其他血管的显着狭窄。排除标准:(1)急性ST段抬高型心肌梗死。(2)既往有 PCI或冠状动脉旁路移植术(coronary artery bypass grafting,CABG)史。(3)冠状动脉粥样硬化之外的其他原因引起ULMCA病变者。(4)不能耐受双联抗血小板聚集治疗(dual antiplatelet therapy,DAPT)者。

1.2 随访及研究终点 主要通过电话、门诊和(或)再次入院进行随访。MACCE包括全因死亡、非致命性心肌梗死、靶血管血运重建(TVR)、卒中,次要终点为心源性死亡、支架内血栓。

1.3 评分及分组方法 (1)SxScore的计算:使用SxScore的网页(www.syntaxscore.com)。(2)SxScoreⅡ的计算:采用bedside application方法[5]。(3)分组方法:≤22分为低分组,23~32分为中分组,≥33分为高分组。

1.4 统计学方法 所有数据采用SPSS 18.0进行统计分析。服从正态分布的连续变量用均数±标准差(±s)表示,不服从正态分布的数据以M(P25,P75)表示,分类变量用例(%)描述,组间比较采用χ2检验。Kaplan-Meier法用以计算生存率,Log-rank χ2检验生存率差异有无统计学意义。采用Cox比例风险模型分析用以计算各因素预测MACCE的HR及其95%CI。以P<0.05为差异有统计学意义。

2 结果

2.1 患者基线特征 共入选患者209例,完成随访197例(94.3%),失访12例。随访时间30.2(25.6,35.8)个月。197例中男 127例,女 70例,年龄(65.8±12.6)岁。吸烟109例(55.3%),高血压129例(65.5%),糖尿病62例(31.5%),冠心病家族史51例(25.9%),高脂血症62例(31.5%),陈旧性心肌梗死16例(8.1%),慢性阻塞性肺疾病(COPD)8例(4.1%),外周血管病(PVD)36例(18.3%),肌酐清除率92.8%±25.2%,患者左室射血分数(LVEF)为0.68±0.09,稳定型心绞痛130例(66.0%),左主干远端分叉病变69例(35.0%),左主干合并3支病变的患者35例(17.8%),SxScore(25.6±7.8)分,SxScoreⅡ(28.6±10.4)分。

2.2 临床事件发生情况 197例患者中全因死亡16例。非致命性心肌梗死11例,TVR 21例,卒中8例,心源性死亡9例,支架内血栓4例。SxScore低、中、高分组MACCE发生率差异有统计学意义,SxScoreⅡ低、中、高分组MACCE发生率、全因死亡和TVR发生率差异均有统计学意义(均P<0.05),见表1、2。以SxScore和SxScoreⅡ,年龄,性别(男= 0,女=1),PVD、吸烟、糖尿病、冠心病家族史(否=0,是=1),LVEF(LVEF≤0.40=0,LVEF>0.40=1)为自变量,以MACCE为因变量,单因素分析结果显示SxScore、SxScoreⅡ、年龄、糖尿病和LVEF为MACCE的影响因素,见表3。多因素分析结果显示SxScore、SxScoreⅡ仍为MACCE的独立影响因素,见表4。

Tab.1 Clinical results of tertile groups of SxScore after PCI表1 SxScore 3组PCI术后的临床结果 例(%)

Tab.2 Clinical results of tertile groups of SxScoreⅡafter PCI表2 SxScoreⅡ3组PCI术后的临床结果 例(%)

Tab.3 Single-factor analysis of MACCE risk factors表3MACCE危险因子的单因素分析

Tab.4 Multivariable analysis of MACCE risk factors表4MACCE危险因子的多因素分析

3 讨论

ULMCA冠心病患者血运重建策略的选择一直困扰着临床医生,SxScore的出现为临床医生选择血运重建方式提供了可靠依据并为国内指南所采用[2]。在临床实际应用中EUROII评分、ACEF评分这些只包含临床特征未包含解剖变量的评分也能很好地评估患者术后风险[6-7]。到底应该根据患者冠脉解剖情况还是临床情况评估术后风险选择血运重建方式,给患者和临床医生带来了困惑。一些联合解剖和临床变量的评分如GRC、CSS评分相比SxScore有更好的评估作用[8-9]。随着SxScore研究的深入,SxScoreⅡ应运而生,在原有解剖评分的基础上增加了年龄、性别、COPD、PVD、肌酐清除率、LVEF这6个临床变量和1个左主干解剖变量。SxScoreⅡ的改变在于:第一,SxScore分值由原来的0~60分下降为8~25分。第二,增大了临床变量的决定作用。第三,由原来的按SxScore对患者进行低、中、高分组,来决定相应的血运重建方案改为预测患者4年的病死率,让患者及临床医生可以量化地预测两种手术方案的远期效果,来选择血运重建方式。

本研究选择SxScore标准作为分组的指标,主要依据为SxScore已经经受了国内外大量的临床研究考验,证明了其分组标准的预测能力并为国内外指南所推荐使用[2,10]。SxScore研究回顾了5年的研究结果提出了SxScoreⅡ,虽然SxScoreⅡ与SxScore有很大的差异,但SxScoreⅡ的研究结果并没有推翻原有SxScore的危险分层系统,而是对原有系统的补充与发展。所以本研究仍以SxScore标准作为危险分层依据。

本研究显示SxScore和SxScoreⅡ均对ULMCA患者PCI术后的MACCE有预测作用,可作为术前风险评估工具。该研究结果与以往的研究结果相一致[11-12]。但在心源性死亡及支架内血栓方面没有预测价值,不符合相关研究的结论[12-13]。SxScoreⅡ增加了6个临床因素更全面地评估患者情况,理论上完善了SxScore单纯解剖评分的局限性,能更准确地对患者PCI术后的临床结果进行预测。但本研究结果显示SxScoreⅡ积分仅在全因死亡及TVR方面优于SxScore积分,这一结果与国外研究相一致[3,14]。SxScore研究中发现年龄、女性、LVEF、COPD、PVD、肌酐清除率这6个临床变量和左主干1个解剖变量与MACCE相关[5]。本研究仅发现年龄是MACCE的危险因素,性别、PVD等临床其他变量均非MACCE的危险因素。SxScoreⅡ只增加了临床和解剖因素,忽视了术者经验、手术策略、完全血运重建等这些对患者临床预后至关重要的人为和操作因素。SxScoreⅡ是否对SxScore有优化作用,是否仍需不断的完善仍有待大量临床研究验证。

本研究为单中心回顾性分析且样本量小,研究的随访时间及支架选择方面与SxScore研究不同。所得结果仍需要多中心、随机对照研究加以证实。

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(2015-12-07收稿 2016-04-02修回)

(本文编辑 魏杰)

Evaluation of SYNTAX score in predicting prognosis of patients with unprotected left main coronary artery disease undergoing percutaneous coronary intervention

LI Jie1,2,ZHANG Mei3
1 Tianjin Medical University,Tianjin 300070,China;2 Department of Cardiology,Tianjin Hospital;3 Department of Cardiology,the Affiliated Hospital of PAP of Logistic College

Objective To evaluate the long-term prognostic capacity of the SYNTAX scoreⅡ(SxScoreⅡ)and SYNTAX score(SxScore)in patients undergoing left main percutaneous coronary intervention(LM-PCI).Methods A total of 209 patients undergoing unprotected LM-PCI in the Cardiology Department of the Affiliated Hospital of PAP of Logistic College were prospectively collected.Follow up was carried out by telephone or outpatient or rehospitalization.The clinical endpoint focused on MACCE after PCI including composite death,nonfatal myocardial infarction,target vessel revascularization and stroke.The secondary endpoint included cardiac death and stent thrombosis.The SxScore and SxScore Ⅱwere retrospectively calculated according to results of coronary angiography and clinical features of patients.Patients were stratified according to tertiles of low(≤22),intermediate(23-32),and high(≥33).The clinical data were comparedbetween three groups.The predictive ability of two scoring systems to MACCE after PCI was compared by COX regression evaluation.Results In 209 patients,12 patients were lost to follow-up(5.7%),and the median follow-up was 30.2 months,56 cases(28.4%)were observed to suffer from MACCE.The incidence rates of MACCE were 19.0%,28.6%and 44.4%in SxScore low,intermediate and high groups respectively.The incidence rates of MACCE were 12.8%,23.8%and 45.5%in SxScoreⅡlow,intermediate and high groups respectively.Single factor analysis showed that SxScore,SxScoreⅡ,age,diabetes and left ventricular ejection fraction(LVEF)were the independent predictors of MACCE.Multivariate analysis showed that SxScore and SxScoreⅡwere still risk independent predictors for MACCE.Conclusion Both SxScore and SxScoreⅡare independent risk predictors for MACCE in patients with unprotected left main coronary artery disease undergoing PCI treatment.

angioplasty,transluminal,percutaneous coronary;coronary artery disease;unprotected left main coronary artery;SxScore;SxScoreⅡ;major adverse cardiac and cerebrovasculur events

R541.4

A

10.11958/20150375

1天津医科大学(邮编300070);2天津市天津医院心内科;3武警后勤学院附属心脏医院

李洁(1978),男,主治医师,本科,主要从事临床心血管疾病诊治方面研究