中國(guó)pci指南解讀課件

中國(guó)pci指南解讀中國(guó)PCI指南解讀中國(guó)pci指南解讀PCI的發(fā)展歷史1844Bernardcoinstheterm“cardiaccatheterization”1929Forssmannpeformsthe1sthumancardiaccatheterization1958Sonesdiscoversthediagnosticcoronaryangiogram1962RickettsandAbramsusethepercutaneousapproachincoronaryarteries1964Dotterintroducestransluminalangioplasty1977Gruentzigpeformsthe1stPTCA1967Judkinsperfectsthetransfemoralapproach1986SigwartandPuelimplantthe1stcoronarystent19941stcoronarystentapprovedbytheFDA2003FDAapprovalof1stDES2006FDApanelonthesafetyofDES2002CEMarkon1stDES中國(guó)pci指南解讀背景藥物洗脫支架（DES）的廣泛應(yīng)用，成為PCI技術(shù)發(fā)展的里程碑新技術(shù)的不斷涌現(xiàn)輔助藥物治療的發(fā)展大量循證醫(yī)學(xué)證據(jù)的出現(xiàn)規(guī)范化治療，保證醫(yī)療質(zhì)量和安全中國(guó)pci指南解讀對(duì)醫(yī)療機(jī)構(gòu)的要求應(yīng)為三級(jí)醫(yī)院，設(shè)有心內(nèi)科、心胸外科、血管造影室和重癥監(jiān)護(hù)室；每年完成診療病例＞200例，治療病例＞100例；術(shù)者需完成PCI每年＞50例；血管造影并發(fā)癥＜0.5%，介入治療死亡率＜0.5%；中國(guó)pci指南解讀血管重建策略的選擇

中國(guó)pci指南解讀藥物治療介入治療CABG中國(guó)pci指南解讀慢性穩(wěn)定性心絞痛的指征有較大范圍心肌缺血的客觀證據(jù)；Ⅰ/A自體冠狀動(dòng)脈的原發(fā)病變常規(guī)置入支架；Ⅰ/A靜脈旁路血管的原發(fā)病變常規(guī)置入支架；Ⅰ/A慢性完全閉塞病變；Ⅱa/C外科手術(shù)高風(fēng)險(xiǎn)患者；Ⅱa/B多支血管病變無(wú)糖尿病，病變適合PCI；Ⅱa/B多支病變合并糖尿病；Ⅱb/C經(jīng)選擇的無(wú)保護(hù)左主干病變；Ⅱb中國(guó)pci指南解讀PCI與藥物治療的比較中國(guó)pci指南解讀早期薈萃分析包括11個(gè)隨機(jī)試驗(yàn)的薈萃分析;N=2,950全因死亡心源性死亡非致死性心梗CABGKatritsisDGetal.Circulation.2005;111:2906-12.012P0.680.280.120.82RiskratioPCI優(yōu)勢(shì)藥物治療優(yōu)勢(shì)中國(guó)pci指南解讀COURAGE試驗(yàn)-設(shè)計(jì)多中心隨機(jī)對(duì)照臨床試驗(yàn)共篩選35,539個(gè)患者共2,287個(gè)患者完成隨機(jī)化有心肌缺血證據(jù)穩(wěn)定性心絞痛隨機(jī)分組PCI+規(guī)范藥物治療vs單純規(guī)范藥物治療隨訪(fǎng)2.5to7年(平均4.6年)BodenWE,NEJM2007;356:1503-16中國(guó)pci指南解讀COURAGE試驗(yàn)-結(jié)果No.atrisk 1,138 1,017 959 834 638 408 192 30 1,149 1,013 952 833 637 417 200 35年份單純藥物PCI+藥物HR1.0595%CI0.87-1.27P=0.62BodenWE,NEJM2007;356:1503-16Survivalfreeofdeathfromanycauseandnonfatalmyocardialinfarction中國(guó)pci指南解讀COURAGE試驗(yàn)-結(jié)果BodenWE,NEJM2007;356:1503-16NumberatRisk藥物治療組113810731029 917 717 468 302 38PCI+藥物組114910941051 929 733 488 312 44Years01234560.00.50.60.70.80.91.0PCI+藥物單純藥物7Hazardratio:0.8795%CI(0.65-1.16)P=0.38OverallSurvival中國(guó)pci指南解讀COURAGE試驗(yàn)-結(jié)果ThecomparisonbetweenthePCIgroupandthemedical-therapygroupwassignificantat1year(P<0.001)and3years(P=0.02)butnotatbaselineor5years.BodenWE,NEJM2007;356:1503-16心絞痛發(fā)生率2550751008887344228332826Baseline1Year3Year5YearP<0.001P=0.02pNSPCI+藥物組單純藥物組中國(guó)pci指南解讀COURAGE試驗(yàn)-結(jié)果LargepreponderenceofproceduralMIs–deathandspontaneousMIactuallylessafterPCI30%ofOMTpatients“crossedover”becauseoffailureofOMTaloneBodenWE,NEJM2007;356:1503-16中國(guó)pci指南解讀COURAGE核醫(yī)學(xué)亞組分析ShawLJetal:Circ117:283,2008PCI+藥物治療(n=159)單純藥物治療(n=155)33.3%with5%

ischemiareduction

(P=0.0004)18.9%with5%

ischemiareductionIndex6-18monthsMean=2.7%(95%CI=-1.7%to-3.8%)8.2%

(7.2-9.3%)

P=0.635.5%

(4.7-6.3%)Index6-18monthsMean=0.5%(95%CI=-1.6%to0.6%)8.6%

(7.5-9.8%)8.1%

(6.9-9.4%)

P<0.0001中國(guó)pci指南解讀近期薈萃分析Schomigetal:JACC52:894,2008中國(guó)pci指南解讀PCI與藥物治療–

指南推薦對(duì)多數(shù)輕度心絞痛（CCSⅠ-Ⅱ級(jí)）患者可先選擇藥物治療；對(duì)心絞痛癥狀較重或希望保持良好體能的患者可考慮PCI；有中、重度心肌缺血的穩(wěn)定性心絞痛患者PCI可改善長(zhǎng)期生存率；Bloodisbetterthandrugsfortheischemicmyocardium-DavidHolmes,MD,FACC中國(guó)pci指南解讀PCI與CABG的比較中國(guó)pci指南解讀緩解心絞痛不需要再次介入完全再血管化費(fèi)用高創(chuàng)傷大費(fèi)用相對(duì)低恢復(fù)快急性并發(fā)癥減少再狹窄問(wèn)題再次血管重建率高PCICABG裸支架時(shí)代CABG更占優(yōu)勢(shì)PCIvs.

CABG中國(guó)pci指南解讀Offpump技術(shù)微創(chuàng)手術(shù)動(dòng)脈橋血管使用圍手術(shù)期管理技術(shù)的進(jìn)步支架設(shè)計(jì)改進(jìn)DES的問(wèn)世PCICABG費(fèi)用高創(chuàng)傷大恢復(fù)時(shí)間長(zhǎng)再狹窄再次血管重建?近年來(lái)隨著介入技術(shù)的進(jìn)展，PCI與CABG差距逐漸縮小PCIvs.

CABG中國(guó)pci指南解讀Sirolimus-elutingstent3.7stentsperpatientAvgtotallength:73mmn=607ARTS-II研究HistoricalControlsfromARTSI:1202patientswithmultivesselcoronarylesions18.2%diabetic28%3vesseldisease7.5%typeClesions607patientswithmultivesselcoronarylesions26.2%diabetic54%3vesseldisease13.9%typeClesionsCABGn=602BareMetalStent2.8stentsperpatientAvgtotallength:48mm n=600Endpoints:Primary –Majoradversecardiacandcerebrovascularevents(MACCE),includingdeath,cerebrovascularevent,myocardialinfarction,andrevascularization,at1yearforthecomparisonofCABGtreatedpatientsintheARTSItrialwithsirolimus-elutingstentpatientsintheARTSIItrial Secondary

–MACCEat30days,6months,3and5years.

–Totalcostat30days

–Costeffectiveness,qualityoflifeat6mo,and1,3,and5years中國(guó)pci指南解讀ARTSII研究：存活率比較p=<0.001p=0.003p=0.46中國(guó)pci指南解讀1年不良事件比較隨訪(fǎng)1年時(shí)，ARTSIIDES組和ARTSICABG組間不良事件率無(wú)明顯差別；

ARTSIBMS組的不良事件率較其它兩組明顯升高。ARTSII研究：1年不良事件比較中國(guó)pci指南解讀p=NSp=NSp=NSp=NSARTSII研究：結(jié)論P(yáng)＜0.01中國(guó)pci指南解讀LeftMainDisease(isolated,+1,+2or+3vessels)3VesselDisease(revascall3vascularterritories)SYNTAX研究：入組條件DenovodiseaseLimitedExclusionCriteriaPreviousinterventionsAcuteMIwithCPK>2xConcomitantcardiacsurgery中國(guó)pci指南解讀71%enrolled

(N=3,075)AllPtswithdenovo3VDand/orLMdisease(N=4,337)Treatmentpreference(9.4%)ReferringMDorpts.refused

informedconsent(7.0%)Inclusion/exclusion(4.7%)Withdrewbeforeconsent(4.3%)Other(1.8%)Medicaltreatment(1.2%)TAXUSn=903PCIn=198CABGn=1077CABGn=897nof/un=4285yrf/un=649PCIallcapturedw/followupCABG2500750w/f/uvsTotalenrollmentN=3075Stratification:

LMandDiabetesTwoRegistryArmsRandomizedArmsn=1800TwoRegistryArmsN=1275RandomizedArmsN=1800HeartTeam(surgeon&interventionalist)PCIN=198CABGN=1077AmenableforonlyonetreatmentapproachTAXUS*N=903

CABGN=897vsAmenableforbothtreatmentoptionsStratification:

LMandDiabetesLM33.7%3VD66.3%LM34.6%3VD65.4%DM28.5%NonDM71.5%NonDM71.8%DM28.2%23USSites62EUSites+SYNTAX研究設(shè)計(jì)*TAXUSExpress中國(guó)pci指南解讀EventRate±1.5SE.*Fisher’sExactTestITTpopulationP=0.37*4.3%3.5%061210200月份CumulativeEventRate(%)TAXUS

(N=903)CABG

(N=897)1年后全因死亡比較中國(guó)pci指南解讀0.6%2.2%061210200月份CumulativeEventRate(%)ITTpopulationP=0.003*EventRate±1.5SE.*Fisher’sExactTestTAXUS

(N=903)CABG

(N=897)1年后腦血管事件比較中國(guó)pci指南解讀P=0.98*061210200月份CumulativeEventRate(%)ITTpopulation7.7%

7.6%EventRate±1.5SE.*Fisher’sExactTestTAXUS

(N=903)CABG

(N=897)1年后全部心腦血管事件比較中國(guó)pci指南解讀5.9%

13.7%061210200月份CumulativeEventRate(%)ITTpopulationP<0.0001*EventRate±1.5SE.*Fisher’sExactTestRepeatRevascCABGGroupPCIGroupPCI4.7%11.4%CABG1.3%2.8%TAXUS

(N=903)CABG

(N=897)1年后再次血管重建比較中國(guó)pci指南解讀糖尿病N=452非糖尿病N=1348TAXUSCABGDeath/CVA/MIMACCEDeath/CVA/MIMACCEP=0.96P=0.0025P=0.08P=0.97糖尿病亞組分析中國(guó)pci指南解讀中國(guó)pci指南解讀Patient1Patient1Patient2Patient2SYNTAXSCORE21SYNTAXSCORE52LCx70-90%LAD70-90%RCA270-90%RCA370-90%LM99%LCx100%LAD99%RCA100%Syntax積分法：三支病變比較中國(guó)pci指南解讀TAXUS(N=299)CABG(N=274)13.5%14.4%P=0.71*061220300月份事件發(fā)生率(%)10Syntax低分區(qū)亞組(0-22)中國(guó)pci指南解讀7.7%13.0%MeanbaselineSYNTAXScoreCABG 15.5±4.3TAXUS 15.7±4.4061220400月份事件發(fā)生率(%)TAXUS

(N=118)CABG

(N=103)P=0.19*1217.3%15.2%MeanbaselineSYNTAXScoreCABG 17.3±3.7TAXUS 17.3±3.8P=0.66*0620400月份事件發(fā)生率(%)12左主干病變?nèi)Р∽僒AXUS

(N=181)CABG

(N=171)Syntax低分區(qū)亞組(0-22)中國(guó)pci指南解讀TAXUS(N=310)CABG(N=300)16.6%11.7%P=0.10*061220300月份事件發(fā)生率(%)10Syntax中分區(qū)亞組(23-32)中國(guó)pci指南解讀P=0.02*MeanbaselineSYNTAXScoreCABG 27.5±2.7TAXUS 27.4±2.9061220400月份事件發(fā)生率(%)18.6%10.0%15.5%12.6%MeanbaselineSYNTAXScoreCABG 27.2±3.0TAXUS 27.0±2.7061220400月份事件發(fā)生率(%)左主干病變?nèi)Р∽僒AXUS

(N=195)CABG

(N=92)TAXUS

(N=207)CABG

(N=208)P=0.54*Syntax中分區(qū)亞組(23-32)中國(guó)pci指南解讀Syntax高分區(qū)亞組(

33)TAXUS(N=290)CABG(N=316)23.3%10.7%P<0.001*061220300MonthsSinceAllocationCumulativeEventRate(%)10中國(guó)pci指南解讀21.5%8.8%MeanbaselineSYNTAXScoreCABG 41.0±6.6TAXUS 39.8±6.0061220400月份CumulativeEventRate(%)P=0.002*P=0.008*25.3%12.9%MeanbaselineSYNTAXScoreCABG 42.1±7.6TAXUS 43.8±9.1061220400月份CumulativeEventRate(%)左主干病變?nèi)Р∽僒AXUS

(N=155)CABG

(N=166)TAXUS

(N=135)CABG

(N=150)Syntax高分區(qū)亞組(

33)中國(guó)pci指南解讀PCI與CABG–

指南推薦適合PCI中等范圍以上心肌缺血或有存活心肌，伴前降支受累的單支或雙支病變能夠進(jìn)行完全血管重建的病變有外科手術(shù)禁忌證、要接受非心臟手術(shù)者ACS，尤其是急性心肌梗死的患者適合CABG左主干病變多支血管病變伴EF＜50%伴有前降支近端明顯狹窄的雙支病變病變不適合PCI或其效果不理想者前降支閉塞而無(wú)前壁MI者PCI不成功或不能進(jìn)行完全血管重建的患者中國(guó)pci指南解讀慢性穩(wěn)定性心絞痛的指征有較大范圍心肌缺血的客觀證據(jù)；Ⅰ/A自體冠狀動(dòng)脈的原發(fā)病變常規(guī)置入支架；Ⅰ/A靜脈旁路血管的原發(fā)病變常規(guī)置入支架；Ⅰ/A慢性完全閉塞病變；Ⅱa/C外科手術(shù)高風(fēng)險(xiǎn)患者；Ⅱa/B多支血管病變無(wú)糖尿病，病變適合PCI；Ⅱa/B多支病變合并糖尿病；Ⅱb/C經(jīng)選擇的無(wú)保護(hù)左主干病變；Ⅱb中國(guó)pci指南解讀非ST抬高ACS的指征對(duì)不穩(wěn)定性心絞痛和非ST段抬高心梗應(yīng)進(jìn)行危險(xiǎn)分層（TIMI、GRACE）；對(duì)極高危患者行緊急P(pán)CI（2h內(nèi)）；Ⅱa/B對(duì)中高?；颊咝性缙赑CI（72h內(nèi)）；Ⅰ/A對(duì)低?；颊卟煌扑]常規(guī)PCI；Ⅲ/C對(duì)PCI患者常規(guī)支架置入；Ⅰ/C對(duì)中高?；颊邍中g(shù)期應(yīng)強(qiáng)化抗血小板、抗凝治療；中國(guó)pci指南解讀STEMI的處理流程中國(guó)pci指南解讀中國(guó)pci指南解讀PCI方法的選擇

中國(guó)pci指南解讀BMS晚期血栓事件極少不需長(zhǎng)期使用雙重抗血小板治療費(fèi)用相對(duì)較低支架內(nèi)再狹窄和再次血管重建問(wèn)題DES支架內(nèi)再狹窄率明顯降低再次血管重建率減少晚期血栓問(wèn)題需長(zhǎng)期使用雙重抗血小板治療費(fèi)用較高DESvsBMS中國(guó)pci指南解讀支架內(nèi)晚期血栓形成的原因抗血小板藥物強(qiáng)度和療程不足內(nèi)皮化延遲復(fù)雜PCI支架聚合物過(guò)敏/炎癥支架內(nèi)血栓中國(guó)pci指南解讀DES和BMS死亡率的比較IntheBASKETLATETrial,cardiacdeathtrendedhigherintheDESgroupthanintheBMSgroupduringtheyearfollowingclopidogreldiscontinuation(1.2%vs0%,P=.09).DatafromthePREMIERregistrylookedexclusivelyatAMIpatientswhoreceivedDESandsuggestedthatpatientswhodiscontinuedthienopyridinetherapyearly—within30daysinthisinstance—weresignificantlymorelik