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1、支架内血栓支架内血栓In-Stent ThrombosisDefinite/Confirmed （肯定的）（肯定的）Acute coronary syndrome ANDAngiographic confirmation of thrombus or occlusion ORPathologic confirmation of acute thrombosisProbable （可能的）（可能的）Unexplained death within 30 daysTarget vessel MI without angiographic confirmation of thrombosis or
2、other identified culprit lesionPossible （不能排除的）（不能排除的）Unexplained death after 30 daysARC 支架内血栓定义支架内血栓定义支架内血栓的预后支架内血栓的预后SES (N=13)BMS (N=15)Death45Myocardial Infarction1313Fatal MI44Q Wave MI85Non-Q Wave MI 58Similar mortality observed for SES and BMS thrombosisSimilar mortality observed for SES and
3、BMS thrombosisPooled Data from RAVEL, SIRIUS, C-SIRIUS, E-SIRIUSPooled Data from RAVEL, SIRIUS, C-SIRIUS, E-SIRIUS支架内血栓发生时间支架内血栓发生时间ST = stent thrombosis; SAT = subacute stent thrombosis;LST = late stent thrombosis; VLST = very late stent thrombosis.Adapted from Bhatt. J Invasive Cardiol. 2003;15(su
4、ppl B):3B.Stent Thrombosis (%)支架内血栓与抗凝、抗血小板治疗支架内血栓与抗凝、抗血小板治疗ASA und TiclopidineASA und AnticoagulationASA und ClopidogrelDESASA = Acetylsalicylic acidDES: Drug-eluting stent Bare Metal StentPrasugrel?BMS支架内血栓发生率支架内血栓发生率Days108642003060120 600NEarly1.2%(N=71)Late0.4%(N=24)Study population 1995-2002-6
5、,058 patients undergoing PCI with BMSWenaweser P et al. EHJ 2005N=1,191N=1,855N=361N=6,058Stent Thrombosis (%)DES肯定的肯定的ST发生率发生率:Bern - Rotterdam Cohort Study Daemen, Wenaweser 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=8
6、14601234Time since PCI in years012345Cumulative incidence, %Months112243648Cumulative incidence, %1.21.62.12.73.3Patients at risk75387210516427901051Incidence density1.0 / 100 pt years3.3%3.50.53% (95% CI=0.44-0.64)/ year192 definite ST casesDES肯定的肯定的ST发生率发生率:Bern-Rotterdam Cohort Study 4 YearsWenaw
7、eser P et al. J Am Coll Cardiol 2008, 52, 1134-0.52% (95% CI=0.42-0.62)/ year between 30 days and 5 yearsDES肯定的支架内血栓发生率肯定的支架内血栓发生率:Bern-Cohort Study 5 YearsWenaweser P et al. ESC 2008Favours DESFavours BMS180 days31-180 days 0-30 daysTime after PCI.1.2.512510 2050 100Odds RatioFavors DESFavors BMS.1
8、.2.5125102050 100Odds RatioAdjusted Resultswith 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 treate
9、d with either BMS or DES (SES or PES), all patients with angiographically documented ST were identified as cases 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 StentSIRT
10、AX Definite 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%Overall Incidence of ST with DESCYPHERTAXUSENDEAVOR XIENCE BIOMATRIX0.40.30.70.51.61
11、.40.8TAXUS IITAXUS IVTAXUS VTAXUS VIREALITYSIRTAXISAR-DM10.50.81.9Endeavor IEndeavor IISpirit IIILeaders0.21.120.61.80.800123SIRIUSE-SIRIUSC-SIRIUSREALITYSIRTAXARTS IIISAR-DM%High Risk of ST in All-Comer Patient Population and STEMI Patients%支架内血栓的病因支架内血栓的病因STENT THROMBOSISStentDesign/LengthPolymerS
12、urfaceDrugsLesionVessel SizeThrombusInterventionResidual DissectionIncomplete Stent AppositionAntithromobotic MedicationPatientGenetic PolymorphismReduced LV-EFAcute Coronary SyndromeHematology DisorderDrugsResistanceDrug-drug InteractionDuration of AntiplateletTreatementVessel ReactionVessel Remode
13、lingHypersensitivity ReactionDelayed Healing早期支架内血栓的预测因素早期支架内血栓的预测因素:残留夹层残留夹层/撕裂撕裂Bare Metal StentsMACE 30 daysSchhlen H et al. Circulation 1998N=2,894Drug-Eluting StentsMACE 30 daysBiondi-Zoccai G et al. EHJ 2006N=2,418%P=0.01P=0.01Residual Dissection: Independent Predictor of MACE (OR=2.9)早期支架内血栓早
14、期支架内血栓IVUS预测因素预测因素 With the Use of Sirolimus-Eluting StentsFujii K et al. J Am Coll Cardiol 2005;45:995-8Minimal Stent CSAP0.001mm2Stent ExpansionResidual Stenosis%P0.001Stent Underexpansion and Residual Reference Segment Stenosis:Independent Predictors of Early Stent Thrombosis!P0.001支架内血栓预测因素支架内血栓
15、预测因素药物反应异常药物反应异常 Wenaweser P et al. JACC 2005; 45(11):1748-52 服药后血小板活性与服药后血小板活性与DES ST的关系的关系Buonamici P et al JACC 2007p0.001p0.001p1 yr) stent There is an increase in “very late” (1 yr) stent thrombosis associated with current DESthrombosis associated with current DES2-4 per 1000 pts per year (? co
16、ntinous hazard, 2-4 per 1000 pts per year (? continous hazard, ? patient and lesion predictors) ? patient and lesion predictors)Data from multiple sources indicate thatData from multiple sources indicate thatDES are associated with delayed healingDES are associated with delayed healingresponses and
17、increased inflammationresponses and increased inflammationThe causes of late DES thrombosis are multi-The causes of late DES thrombosis are multi-factorial; device, procedural, and patientfactorial; device, procedural, and patientfactors (often multiple = perfect storm) factors (often multiple = per
18、fect storm) 专家共识专家共识FDA DES Panel Meeting There may be a link between post-DES reduced There may be a link between post-DES reduced neo-intimal hyperplasia (late loss) and delayed neo-intimal hyperplasia (late loss) and delayed late healing responses which contributes to late late healing responses
19、which contributes to late stent thrombosisstent thrombosis DES stent thrombosis is highly definition DES stent thrombosis is highly definition dependent; need for revised standardizeddependent; need for revised standardizeddefinitions and adjudication methods (ARC) definitions and adjudication metho
20、ds (ARC) to facilitate inter-study comparisonsto facilitate inter-study comparisons专家共识专家共识“Off-label DES use increased incidence of late “Off-label DES use increased incidence of late DES thrombosis and death/MI cw “on-label”, butDES thrombosis and death/MI cw “on-label”, butinadequate controls; re
21、sults inconsistent!inadequate controls; results inconsistent! Few RCTs (underpowered); FDA sanctioned Few RCTs (underpowered); FDA sanctioned registries = insufficient sample size and FU, registries = insufficient sample size and FU, represents major data gap and source of represents major data gap
22、and source of concernconcernLarge population studies (SCAAR) fraught Large population studies (SCAAR) fraught with methodologic flaws (e.g. risk adjustment with methodologic flaws (e.g. risk adjustment issues) issues) 专家共识专家共识Duration of dual anti-platelet therapy should Duration of dual anti-platel
23、et therapy should extend beyond the present product labelsextend beyond the present product labelsOOne year is reasonable compromise (esp. forne year is reasonable compromise (esp. for“off-label” DES use)“off-label” DES use)Must balance against the increased risk ofMust balance against the increased
24、 risk ofbleeding with dual anti-platelet therapybleeding with dual anti-platelet therapyAdditional studies immediately required toAdditional studies immediately required tobetter clarify optimal anti-platelet therapybetter clarify optimal anti-platelet therapy专家共识专家共识Assess patient and lesion charac
25、teristics to Assess patient and lesion characteristics to establish restenosis risk profileestablish restenosis risk profileDetermine relative value of DES vs. BMS inDetermine relative value of DES vs. BMS inevery patient (no more “unrestricted” use) every patient (no more “unrestricted” use) Consid
26、er both on-label and off-label Consider both on-label and off-label situations (ironically, off-label use scenarios situations (ironically, off-label use scenarios may be more compelling)may be more compelling)Increased restenosis risk = favor DESIncreased restenosis risk = favor DESIncreased safety
27、 concerns = favor No DES Increased safety concerns = favor No DES 专家共识专家共识Assess patient factors which may preclude long-Assess patient factors which may preclude long-term (at least one year) dual AP therapyterm (at least one year) dual AP therapyPlanned or possible intercurrent surgeryPlanned or p
28、ossible intercurrent surgeryBleeding Hx or tendenciesBleeding Hx or tendenciesOther concomitant medications (e.g. Other concomitant medications (e.g. coumadin)coumadin)Socio-economic factors which may affect Socio-economic factors which may affect Plavix compliance Plavix compliance 专家共识专家共识Consider
29、 alternatives to DES, if risk-benefit Consider alternatives to DES, if risk-benefit assessments prove unfavorableassessments prove unfavorableCABG unprotected LM disease, complex CABG unprotected LM disease, complex MVD (esp. diabetics), recurrent ISR (esp. VBT) MVD (esp. diabetics), recurrent ISR (
30、esp. VBT) BMS Plavix dependence concerns, large BMS Plavix dependence concerns, large (4mm diameter) vessels, ? AMI pts, ? low (4mm diameter) vessels, ? AMI pts, ? low restenosis risk lesionsrestenosis risk lesionsBalloon PCI sidebranch in bifurcations Balloon PCI sidebranch in bifurcations (provisi
31、onal stent only), small vessels in distal (provisional stent only), small vessels in distal locations locations 专家共识专家共识Optimize DES implantation techniquesOptimize DES implantation techniquesAdequate lesion preparation (pre-dilatation)Adequate lesion preparation (pre-dilatation)High pressure implan
32、tation methodologies High pressure implantation methodologies (like previous BMS strategies)(like previous BMS strategies)Avoid undersizing and inflow/outflow Avoid undersizing and inflow/outflow obstruction (mod stenoses or dissections)obstruction (mod stenoses or dissections)Implant stent edges in
33、to normal references Implant stent edges into normal references segmentssegmentsConsider IVUS guidance (esp. LAD) Consider IVUS guidance (esp. LAD) 专家共识专家共识Careful explanations and open communication Careful explanations and open communication with patients and familieswith patients and familiesCare
34、ful pre-treatment historyCareful pre-treatment historyDiscussion with EVERY pt re: risks and Discussion with EVERY pt re: risks and benefits of DES vs. alternative therapiesbenefits of DES vs. alternative therapiesOngoing (post-Rx) communication and careful Ongoing (post-Rx) communication and carefu
35、l FU re: dual AP compliance (instructions = NO FU re: dual AP compliance (instructions = NO PlavixPlavix discontinuation without MD approval)! discontinuation without MD approval)! DES 风险风险 & 获益获益治疗治疗1000个病人可以预防个病人可以预防100个再狭窄个再狭窄同时可以预防同时可以预防10个再狭窄相关的心肌梗个再狭窄相关的心肌梗死死可能会因为晚期支架内血栓增加可能会因为晚期支架内血栓增加5个心肌个心肌梗死梗死获益获益风险风险
