李潔,張梅
SYNTAX評分對接受PCI治療的無保護左主干病變患者的預(yù)測價值
李潔1,2,張梅3
目的 研究SYNTAX評分(SxScore)和SYNTAXⅡ評分(SxScoreⅡ)對無保護左主干(ULMCA)冠心病患者接受經(jīng)皮冠狀動脈介入治療(PCI)術(shù)后30個月的主要不良心腦血管事件(MACCE)的預(yù)測能力。方法 回顧性分析武警后勤學(xué)院附屬醫(yī)院心內(nèi)科接受PCI治療的209例ULMCA冠心病患者,通過電話、門診和(或)再次入院隨訪患者PCI術(shù)后的MACCE,包括全因死亡、非致命性心肌梗死、靶血管血運重建、卒中及次要終點事件包括心源性死亡、支架內(nèi)血栓。根據(jù)冠狀動脈造影結(jié)果及臨床特征計算SxScore和SxScoreⅡ,根據(jù)SxScore標準分為低分組≤22分,中分組23~32分,高分組≥33分,比較3組的臨床資料,Cox回歸評價兩種評分系統(tǒng)對PCI術(shù)后MACCE的預(yù)測能力。結(jié)果 209例患者中,失訪12例(5.7%),中位隨訪時間為30.2個月,56例(28.4%)觀察到MACCE。SxScore低、中、高分組的MACCE發(fā)生率分別為19.0%,28.6%和44.4%。SxScoreⅡ低、中、高分組的MACCE發(fā)生率分別為12.8%、23.8%和45.5%。單因素分析結(jié)果顯示SxScore、SxScoreⅡ高分值、高齡、合并糖尿病和低左室射血分數(shù)(LVEF)為MACCE的危險因子,多因素分析結(jié)果顯示SxScore、SxScoreⅡ高分值仍為MACCE的獨立危險因子。結(jié)論 SxScore 和SxScoreⅡ?qū)跔顒用}ULMCA病變患者行PCI治療后的MACCE均有預(yù)測作用。
血管成形術(shù),經(jīng)腔,經(jīng)皮冠狀動脈;冠狀動脈疾病;無保護左主干;SxScore;SxScoreⅡ;主要不良心腦血管事件
2009年歐洲心血管病會議(European Society Congress,ESC)上公布了SYNTAX研究并提出了SYNTAX評分(SxScore)[1],即以冠狀動脈病變的嚴重程度來進行危險分層以指導(dǎo)患者血運重建策略的選擇。目前大量的國外相關(guān)研究已證實SxScore對于無保護左主干(unprotected left main coronary artery,ULMCA)患者經(jīng)皮冠狀動脈介入治療(percutaneous coronary intervention,PCI)術(shù)后遠期效果有預(yù)測價值并被國內(nèi)指南采納[2]。2013年Farooq等[3]公布了SYNTAX研究5年結(jié)果并提出了一個新的評分方法——SYNTAXⅡ評分(SxScoreⅡ)。SxScoreⅡ由原來的1個解剖變量增加為2個解剖變量和6個臨床變量。國外有研究認為其預(yù)測作用優(yōu)于SxScore,但相關(guān)研究較少[4]。本研究旨在探討SxScore和 SxScoreⅡ?qū)?ULMCA患者 PCI術(shù)后主要不良心腦血管事件(major adverse cardiac and cerebrovasculur events,MACCE)的預(yù)測能力。
1.1 研究對象 回顧性分析2009年6月—2012年1月在天津武警后勤學(xué)院附屬醫(yī)院心內(nèi)科接受PCI治療的ULMCA的冠心病患者。全部病例均符合ULMCA病變定義,同時不存在通暢的血管橋或自身右向左良好側(cè)支循環(huán)。納入標準:(1)心肌缺血導(dǎo)致的穩(wěn)定型心絞痛、不穩(wěn)定型心絞痛、非ST段抬高型心肌梗死、不典型胸痛或者無癥狀但有客觀缺血證據(jù)者。(2)未經(jīng)干預(yù)的原位病變。(3)冠脈造影左主干狹窄程度≥50%,無通暢的血管橋或側(cè)支循環(huán),可伴有其他血管的顯著狹窄。排除標準:(1)急性ST段抬高型心肌梗死。(2)既往有 PCI或冠狀動脈旁路移植術(shù)(coronary artery bypass grafting,CABG)史。(3)冠狀動脈粥樣硬化之外的其他原因引起ULMCA病變者。(4)不能耐受雙聯(lián)抗血小板聚集治療(dual antiplatelet therapy,DAPT)者。
1.2 隨訪及研究終點 主要通過電話、門診和(或)再次入院進行隨訪。MACCE包括全因死亡、非致命性心肌梗死、靶血管血運重建(TVR)、卒中,次要終點為心源性死亡、支架內(nèi)血栓。
1.3 評分及分組方法 (1)SxScore的計算:使用SxScore的網(wǎng)頁(www.syntaxscore.com)。(2)SxScoreⅡ的計算:采用bedside application方法[5]。(3)分組方法:≤22分為低分組,23~32分為中分組,≥33分為高分組。
1.4 統(tǒng)計學(xué)方法 所有數(shù)據(jù)采用SPSS 18.0進行統(tǒng)計分析。服從正態(tài)分布的連續(xù)變量用均數(shù)±標準差(±s)表示,不服從正態(tài)分布的數(shù)據(jù)以M(P25,P75)表示,分類變量用例(%)描述,組間比較采用χ2檢驗。Kaplan-Meier法用以計算生存率,Log-rank χ2檢驗生存率差異有無統(tǒng)計學(xué)意義。采用Cox比例風(fēng)險模型分析用以計算各因素預(yù)測MACCE的HR及其95%CI。以P<0.05為差異有統(tǒng)計學(xué)意義。
2.1 患者基線特征 共入選患者209例,完成隨訪197例(94.3%),失訪12例。隨訪時間30.2(25.6,35.8)個月。197例中男 127例,女 70例,年齡(65.8±12.6)歲。吸煙109例(55.3%),高血壓129例(65.5%),糖尿病62例(31.5%),冠心病家族史51例(25.9%),高脂血癥62例(31.5%),陳舊性心肌梗死16例(8.1%),慢性阻塞性肺疾病(COPD)8例(4.1%),外周血管?。≒VD)36例(18.3%),肌酐清除率92.8%±25.2%,患者左室射血分數(shù)(LVEF)為0.68±0.09,穩(wěn)定型心絞痛130例(66.0%),左主干遠端分叉病變69例(35.0%),左主干合并3支病變的患者35例(17.8%),SxScore(25.6±7.8)分,SxScoreⅡ(28.6±10.4)分。
2.2 臨床事件發(fā)生情況 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,支架內(nèi)血栓4例。SxScore低、中、高分組MACCE發(fā)生率差異有統(tǒng)計學(xué)意義,SxScoreⅡ低、中、高分組MACCE發(fā)生率、全因死亡和TVR發(fā)生率差異均有統(tǒng)計學(xué)意義(均P<0.05),見表1、2。以SxScore和SxScoreⅡ,年齡,性別(男= 0,女=1),PVD、吸煙、糖尿病、冠心病家族史(否=0,是=1),LVEF(LVEF≤0.40=0,LVEF>0.40=1)為自變量,以MACCE為因變量,單因素分析結(jié)果顯示SxScore、SxScoreⅡ、年齡、糖尿病和LVEF為MACCE的影響因素,見表3。多因素分析結(jié)果顯示SxScore、SxScoreⅡ仍為MACCE的獨立影響因素,見表4。
Tab.1 Clinical results of tertile groups of SxScore after PCI表1 SxScore 3組PCI術(shù)后的臨床結(jié)果 例(%)
Tab.2 Clinical results of tertile groups of SxScoreⅡafter PCI表2 SxScoreⅡ3組PCI術(shù)后的臨床結(jié)果 例(%)
Tab.3 Single-factor analysis of MACCE risk factors表3MACCE危險因子的單因素分析
Tab.4 Multivariable analysis of MACCE risk factors表4MACCE危險因子的多因素分析
ULMCA冠心病患者血運重建策略的選擇一直困擾著臨床醫(yī)生,SxScore的出現(xiàn)為臨床醫(yī)生選擇血運重建方式提供了可靠依據(jù)并為國內(nèi)指南所采用[2]。在臨床實際應(yīng)用中EUROII評分、ACEF評分這些只包含臨床特征未包含解剖變量的評分也能很好地評估患者術(shù)后風(fēng)險[6-7]。到底應(yīng)該根據(jù)患者冠脈解剖情況還是臨床情況評估術(shù)后風(fēng)險選擇血運重建方式,給患者和臨床醫(yī)生帶來了困惑。一些聯(lián)合解剖和臨床變量的評分如GRC、CSS評分相比SxScore有更好的評估作用[8-9]。隨著SxScore研究的深入,SxScoreⅡ應(yīng)運而生,在原有解剖評分的基礎(chǔ)上增加了年齡、性別、COPD、PVD、肌酐清除率、LVEF這6個臨床變量和1個左主干解剖變量。SxScoreⅡ的改變在于:第一,SxScore分值由原來的0~60分下降為8~25分。第二,增大了臨床變量的決定作用。第三,由原來的按SxScore對患者進行低、中、高分組,來決定相應(yīng)的血運重建方案改為預(yù)測患者4年的病死率,讓患者及臨床醫(yī)生可以量化地預(yù)測兩種手術(shù)方案的遠期效果,來選擇血運重建方式。
本研究選擇SxScore標準作為分組的指標,主要依據(jù)為SxScore已經(jīng)經(jīng)受了國內(nèi)外大量的臨床研究考驗,證明了其分組標準的預(yù)測能力并為國內(nèi)外指南所推薦使用[2,10]。SxScore研究回顧了5年的研究結(jié)果提出了SxScoreⅡ,雖然SxScoreⅡ與SxScore有很大的差異,但SxScoreⅡ的研究結(jié)果并沒有推翻原有SxScore的危險分層系統(tǒng),而是對原有系統(tǒng)的補充與發(fā)展。所以本研究仍以SxScore標準作為危險分層依據(jù)。
本研究顯示SxScore和SxScoreⅡ均對ULMCA患者PCI術(shù)后的MACCE有預(yù)測作用,可作為術(shù)前風(fēng)險評估工具。該研究結(jié)果與以往的研究結(jié)果相一致[11-12]。但在心源性死亡及支架內(nèi)血栓方面沒有預(yù)測價值,不符合相關(guān)研究的結(jié)論[12-13]。SxScoreⅡ增加了6個臨床因素更全面地評估患者情況,理論上完善了SxScore單純解剖評分的局限性,能更準確地對患者PCI術(shù)后的臨床結(jié)果進行預(yù)測。但本研究結(jié)果顯示SxScoreⅡ積分僅在全因死亡及TVR方面優(yōu)于SxScore積分,這一結(jié)果與國外研究相一致[3,14]。SxScore研究中發(fā)現(xiàn)年齡、女性、LVEF、COPD、PVD、肌酐清除率這6個臨床變量和左主干1個解剖變量與MACCE相關(guān)[5]。本研究僅發(fā)現(xiàn)年齡是MACCE的危險因素,性別、PVD等臨床其他變量均非MACCE的危險因素。SxScoreⅡ只增加了臨床和解剖因素,忽視了術(shù)者經(jīng)驗、手術(shù)策略、完全血運重建等這些對患者臨床預(yù)后至關(guān)重要的人為和操作因素。SxScoreⅡ是否對SxScore有優(yōu)化作用,是否仍需不斷的完善仍有待大量臨床研究驗證。
本研究為單中心回顧性分析且樣本量小,研究的隨訪時間及支架選擇方面與SxScore研究不同。所得結(jié)果仍需要多中心、隨機對照研究加以證實。
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(2015-12-07收稿 2016-04-02修回)
(本文編輯 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天津醫(yī)科大學(xué)(郵編300070);2天津市天津醫(yī)院心內(nèi)科;3武警后勤學(xué)院附屬心臟醫(yī)院
李潔(1978),男,主治醫(yī)師,本科,主要從事臨床心血管疾病診治方面研究