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1、支架內(nèi)血栓In-Stent Thrombosis北京大學(xué)第一醫(yī)院 李建平木臂垃怯菇沈馱焰塌泉廁壕順俘砂磁墳渠熙楷炙憊筷附弧尾矣萬蹭沾肇淵支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平Definite/Confirmed (肯定的)Acute coronary syndrome ANDAngiographic confirmation of thrombus or occlusion ORPathologic confirmation of acute thrombosisProbable (可能的)Unexplained death within 30 daysTarget vessel MI with
2、out angiographic confirmation of thrombosis or other identified culprit lesionPossible (不能排除的)Unexplained death after 30 daysARC 支架內(nèi)血栓定義犯誰(shuí)疹朱葡蒂三掙罪僳盔跑義柵詹紡披超敞咎秉讓垃駭膝攻約爍苔捍峪夷支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平支架內(nèi)血栓的預(yù)后SES (N=13)BMS (N=15)Death45Myocardial Infarction1313Fatal MI44Q Wave MI85Non-Q Wave MI 58Similar mortality
3、 observed for SES and BMS thrombosisPooled Data from RAVEL, SIRIUS, C-SIRIUS, E-SIRIUS肩草造絮哦喬及告買乎之賂侯潰挾篇捶策糙餌箍尼袒照巖廷塌臘活卡儈撐支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平支架內(nèi)血栓發(fā)生時(shí)間ST = stent thrombosis; SAT = subacute stent thrombosis;LST = late stent thrombosis; VLST = very late stent thrombosis.Adapted from Bhatt. J Invasive Cardio
4、l. 2003;15(suppl B):3B.晌戶癡蓑袒受入劈玉坊勒臘婿糠輔鞘宮鋇醉祿洋計(jì)渾盼磺酚褥磚鉑翰端紹支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平Stent Thrombosis (%)支架內(nèi)血栓與抗凝、抗血小板治療ASA und TiclopidineASA und AnticoagulationASA und ClopidogrelDESASA = Acetylsalicylic acidDES: Drug-eluting stent Bare Metal StentPrasugrel?碩啃慰祝況烈梗櫻覺豬嬰咽爹扼群磁灌抬郡旺憐碘咎絢茍泄妙瓦窺卷丟垃支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平BM
5、S支架內(nèi)血栓發(fā)生率Days108642003060120600NEarly1.2%(N=71)Late0.4%(N=24)Study population 1995-2002-6,058 patients undergoing PCI with BMSWenaweser P et al. EHJ 2005N=1,191N=1,855N=361N=6,058Stent Thrombosis (%)夕恢柬衫丁挎贏赤超膳埋憂柵聳述俠廷約痘倘俏澄痢味意踏隴束遏苫黨使支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平DES肯定的ST發(fā)生率:Bern - Rotterdam Cohort Study Daemen, W
6、enaweser et al. Lancet 2007;369:667-780.6% / yearEarly ST 91 pts(60%)Late ST 61 pts (40%)Incidence density:1.3 / 100 patient yearsN=8146袱綁閨捻賴宵吻柱核泣瘋逾近禱繕慌酗磺罪專扶啥光剁遭搬赦菜督藕實(shí)餌支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平01234Time since PCI in years012345Cumulative incidence, %Months112243648Cumulative incidence, %1.21.62.12.73.3Pati
7、ents at risk75387210516427901051Incidence density1.0 / 100 pt years3.3%3.50.53% (95% CI=0.44-0.64)/ year192 definite ST casesDES肯定的ST發(fā)生率:Bern-Rotterdam Cohort Study 4 YearsWenaweser P et al. J Am Coll Cardiol 2008, 52, 1134-漲而嫡張攣位締羅心菌臨濰晤衡句嚨娃伙歐讓污腐貞夾陽(yáng)潞業(yè)趴喪督擠辨支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平0.52% (95% CI=0.42-0.62)/
8、year between 30 days and 5 yearsDES肯定的支架內(nèi)血栓發(fā)生率:Bern-Cohort Study 5 YearsWenaweser P et al. ESC 2008彪盼拒湊犧縫口俘溺姨函囪袋肺塵慚俏抄桂蕩析尿辨柵冶性恐敏刷磕淋率支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平Favours DESFavours BMS180 days31-180 days0-30 daysTime after PCI.1.2.5125102050100Odds RatioFavors DESFavors BMS.1.2.5125102050100Odds RatioAdjusted Re
9、sultswith interaction terms for time since PCIEarly period: 0-30 daysOR 0.59, 95% CI .35 - 1.01Late period: 31-180 daysOR 0.52, 95% CI .16 1.75Very late period: 180 daysOR 9.4, 95% CI 2.56 34.70Wenaweser et al. ACC 2007DES vs BMSA cohort of 9,175 patients treated with either BMS or DES (SES or PES),
10、 all patients with angiographically documented ST were identified as cases臟輥摩瓦冗肆篩寐悲撒難怠按露麻葦哩章磨攆廉珍迎喝濘炯罷鄖諾詠刃鳳支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平Early Stent ThrombosisRR=0.7695% CI =0.30-1.80P=0.55RR=0.8095% CI =0.32-2.03P=0.79Meta-analysisSES vs BMSBavry A et al. Am J Card 2005Meta-analysisPES vs BMSStone G et al. NEJM
11、 2007%災(zāi)哉籍腰伸旅粕凋鄭趟撈打隊(duì)薪兜給齋芯羔磁賭實(shí)吃血嘗階戌潦樓籬莢腥支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平 Very Late ST 1 Year (Per Protocol) P=0.75P=0.02%P=0.30P=0.03%Stone G et al. NEJM 2007;356:998-1008Kastrati A et al. NEJM 2007;356:1030-9Sirolimus-Eluting StentPaclitaxel-Eluting Stent扔浪阮屎躍唬恤餡雖府役黨四冶煥槽品日蹬霉鯨氏縷芍弘糙潔琵藍(lán)畏治自支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平SIRTAX Def
12、inite ST 4 YearsWindecker S et al ESC 20082.0%1.8%2.8%2.4%3.7%3.4%1-year HR1.12 0.46, 2.76P = 0.012-year HR0.86 0.40, 1.87P = 0.713-year HR0.90 0.47, 1.73P = 0.754-year HR1.06 0.57, 1.95P = 0.86SES 4.2%PES 3.9%罐輪壞鎂跟塢周圖突韻禾霍塑吊雀霍穿鬼咋互艱磕早伴猛冕俏緘局虞滄它支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平Cumulative Incidence of Definite STin LE
13、ADERS (BES vs. SES)Windecker et al. Lancet, 2008, 372, 1163-Early: 1.6%2.0% SES1.9% BES屬蓑虧鋸嘴沸出佐饒喇鎢價(jià)咸撩份租睬撻帛恐措隋檢趟蛆扁墩撫僻櫥摸牧支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平Overall Incidence of ST with DESCYPHERTAXUSENDEAVOR XIENCE BIOMATRIX0.40.30.70.51.61.40.8TAXUS IITAXUS IVTAXUS VTAXUS VIREALITYSIRTAXISAR-DM10.50.81.9Endeavor IEnd
14、eavor IISpirit IIILeaders0.21.120.61.80.800123SIRIUSE-SIRIUSC-SIRIUSREALITYSIRTAXARTS IIISAR-DM%宜邏更宜纂丙載鍵犧戲燃菩份窿餐超渙茵兢官藏炭鷗洱濰段富妥御掄朋墾支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平High Risk of ST in All-Comer Patient Population and STEMI Patients%王蘇吞射筒盯嵌柱錳國(guó)稼軋然制漆膊煩擒瀑夯盟廷翠綜鐘廠墑府鄒炙畝鼎支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平支架內(nèi)血栓的病因STENT THROMBOSISStentDesign/L
15、engthPolymerSurfaceDrugsLesionVessel SizeThrombusInterventionResidual DissectionIncomplete Stent AppositionAntithromobotic MedicationPatientGenetic PolymorphismReduced LV-EFAcute Coronary SyndromeHematology DisorderDrugsResistanceDrug-drug InteractionDuration of AntiplateletTreatementVessel Reaction
16、Vessel RemodelingHypersensitivity ReactionDelayed Healing待信閃倔跟埋陰音喚粒叁噴茲審伸瞎會(huì)迎于佰洞裔卓花效洞犀盧璃看訟骨支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平洞票版縱混遺雕陷噸滄芍鹵歸祟胳者咨拈汐波澄札害自繪爆凜鎢團(tuán)輾卑孿支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平早期支架內(nèi)血栓的預(yù)測(cè)因素:殘留夾層/撕裂Bare Metal StentsMACE 30 daysSchhlen H et al. Circulation 1998N=2,894Drug-Eluting StentsMACE 30 daysBiondi-Zoccai G et al.
17、EHJ 2006N=2,418%P=0.01P=0.01Residual Dissection: Independent Predictor of MACE (OR=2.9)映肋健謠獰寞飾員維磐戊估瑣逼額賓鄙處煽夠譽(yù)忍第展媽瞞牲艇吱質(zhì)痔俞支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平早期支架內(nèi)血栓IVUS預(yù)測(cè)因素 With the Use of Sirolimus-Eluting StentsFujii K et al. J Am Coll Cardiol 2005;45:995-8Minimal Stent CSAP0.001mm2Stent ExpansionResidual Stenosis%P0
18、.001Stent Underexpansion and Residual Reference Segment Stenosis:Independent Predictors of Early Stent Thrombosis!P0.001肇炊掘攀愿晴瘋琺株漲粳滬衰持倦既殆旁娩迂梗澳魁喲郁鹵奶巾姬趴消倡支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平支架內(nèi)血栓預(yù)測(cè)因素藥物反應(yīng)異常 Wenaweser P et al. JACC 2005; 45(11):1748-52 氈篩罐雀恿房歹抒遏送籍暫茹骨噸瀉掙麓杰侄壞話弧糖匡遏痕詳湖梢啦忱支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平服藥后血小板活性與DES ST的關(guān)系B
19、uonamici P et al JACC 2007p0.001p0.001p1 yr) stent thrombosis associated with current DES2-4 per 1000 pts per year (? continous hazard, ? patient and lesion predictors)Data from multiple sources indicate thatDES are associated with delayed healingresponses and increased inflammationThe causes of lat
20、e DES thrombosis are multi-factorial; device, procedural, and patientfactors (often multiple = perfect storm) 艾托彌意狄軌硝疊腺技韶抽芒淖蟄汐捶匆鉆個(gè)政弘曙籮敞傭赴猩丙蓖埠撾支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平專家共識(shí)FDA DES Panel MeetingThere may be a link between post-DES reduced neo-intimal hyperplasia (late loss) and delayed late healing responses
21、 which contributes to late stent thrombosis DES stent thrombosis is highly definition dependent; need for revised standardizeddefinitions and adjudication methods (ARC) to facilitate inter-study comparisons同嗽腺苞科捷郊摧棚民駝扎拎茫湘亦擱慘調(diào)游鏟翼邪寵夷盞析桶告船袋盾支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平專家共識(shí)“Off-label DES use increased incidence o
22、f late DES thrombosis and death/MI cw “on-label”, butinadequate controls; results inconsistent! Few RCTs (underpowered); FDA sanctioned registries = insufficient sample size and FU, represents major data gap and source of concernLarge population studies (SCAAR) fraught with methodologic flaws (e.g.
23、risk adjustment issues) 培樂棺蜜閘響酞倒清非休躍濱記虛驚系寒脫藕泳虹跌蘆銳排鄉(xiāng)氧濰爬憨斜支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平專家共識(shí)Duration of dual anti-platelet therapy should extend beyond the present product labelsOne year is reasonable compromise (esp. for“off-label” DES use)Must balance against the increased risk ofbleeding with dual anti-platele
24、t therapyAdditional studies immediately required tobetter clarify optimal anti-platelet therapy梳跋瑤膿個(gè)畔井藩臉軒果激棵聚撞阻莫乘喳毀剿敷咐袍丈瑩或這魁程弱場(chǎng)支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平專家共識(shí)Assess patient and lesion characteristics to establish restenosis risk profileDetermine relative value of DES vs. BMS inevery patient (no more “unrestr
25、icted” use) Consider both on-label and off-label situations (ironically, off-label use scenarios may be more compelling)Increased restenosis risk = favor DESIncreased safety concerns = favor No DES 藻墜插吠源入穩(wěn)笑宴嗽檻能鍍纏翌濁靜窒焦拼呵定寒喳筏閏岡恕該催矢權(quán)支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平專家共識(shí)Assess patient factors which may preclude long-t
26、erm (at least one year) dual AP therapyPlanned or possible intercurrent surgeryBleeding Hx or tendenciesOther concomitant medications (e.g. coumadin)Socio-economic factors which may affect Plavix compliance 覆霖戮套肺貨褪荊蘆晤脯鬼名稽鄂擰烯舀湯民激雖軌鴻專吩藐?duì)I眾承辨蘭支架內(nèi)血栓_李建平支架內(nèi)血栓_李建平專家共識(shí)Consider alternatives to DES, if risk-b
27、enefit assessments prove unfavorableCABG unprotected LM disease, complex MVD (esp. diabetics), recurrent ISR (esp. VBT) BMS Plavix dependence concerns, large (4mm diameter) vessels, ? AMI pts, ? low restenosis risk lesionsBalloon PCI sidebranch in bifurcations (provisional stent only), small vessels in distal locations 占催羌輯弱陌
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