超过再灌注治疗时间窗的STEMI患者的介入治疗策略选择.ppt

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,*,超过再灌注治疗时间窗的,STEMI,患者的介入治疗策略选择,浙江大学医学院附属第一医院,朱建华,2011.11.20 2011ACS,研讨会 北京亮马河大厦,Circulation.2003;108:III-14-III-21,Data from TETAMI Study,12,小时,STEMI,的特点,以高龄患者为多；,多合并其它疾病（糖尿病、高血压、慢性肾病、脑血管疾病、肿瘤等）；,更倾向于保守治疗；,当地医疗条件相对不足，依从性差；,Circulation.1977;56:786-794,40min,3 hours,24 hours,96 hours,Time Is Muscle,Muscle Is Life,JAMA.2005;293(8):979-986,OAT,试验,:,研究设计,一级终点,:,死亡，心梗，或,NYHA IV,心衰,PCI,n=1082,药物治疗,n=1084,2166 patients with angiography on day 3-28 post-MI with evidence of total occlusion of the infarct-related artery with poor or absent antegrade flow(TIMI flow grade 0 or 1);and met a criterion for increased risk,defined as ejection fraction 2.5 mg/dl,angiographically significant left main or three-vessel coronary artery disease,angina at rest,or severe ischemia on stress testing.,Randomized.,22%female,mean age 59 years,mean follow-up 3 years,mean EF 48%at baseline,Concomitant medications:Aspirin,anticoagulation if indicated,ACE inhibitors,beta-blockers,and lipid-lowering therapy,unless contraindicated,N Engl J Med 2006;355:23952407.,OAT,试验,:,一级终点,N Engl J Med 2006;355:23952407.,Primary Endpoint of death,reinfarction,NYHA class IV heart failure(patients),Hazard Ratio 1.16,p=0.20,OAT Trial:,Primary Component Endpoints,N Engl J Med 2006;355:23952407.,Primary Component Endpoints(%patients),Total,Reinfarction,%patients,Nonfatal,Reinfarction,Death,Repeated,of Cardiac,Biomarkers,NYHA Class IV Heart,Failure,p=0.13,p=0.08,p0.001,p=0.83,p=0.92,OAT试验,:,小结,N Engl J Med 2006;355:23952407.,对心肌梗死后,3-28,天梗死相关血管全闭的稳定的高危病人行,PCI,治疗与药物治疗相比，,3,年随访发现，死亡，再梗或心衰复合终点无显著差异。,尽管复合终点无差异，但是，,PCI,与药物治疗相比再梗的发生率有增加的趋势。,对,PCI,再梗率有增加的趋势的一个解释是，可能是栓塞造成心肌损害和损害了侧枝血流所致。,12,小时,STEMI,的指南建议,临床表现,ESC 2008,ACC/AHA/SCAI 2009,12,小时就诊，同时伴有：,再发心梗,N/A,急诊,PCI(Class I,LOE:C),心源性休克,or,血流动力学不稳定,急症,PCI(Class I,LOE:C),急诊,PCI(Class I,LOE:B),恶性心律失常,or,心衰,N/A,急诊,PCI(Class,IIa,LOE:C),12,小时就诊，同时伴有持续性心绞痛,急诊,PCI(Class,IIa,LOE:C),急诊,PCI(Class I,LOE:B),12-24,小时就诊，无症状,急诊,PCI(Class,IIb,LOE:B),N/A,24,小时就诊，无症状,不推荐急诊,PCI,(Class III,LOE:B),不推荐急诊,PCI,(Class III,LOE:B),对于,12-24,小时无症状,STEMI,患者是否要行急诊,PCI,存在争议,将,12,小时,作为分界点过于武断（主要来源于溶栓时代的研究），,PCI,相较于溶栓有许多不同点；,血栓抽吸装置的出现为,PCI,治疗提供了更多优势；,自然状态的,AMI,不同于动物实验的单纯阻断血管（残余前向血流、缺血预适应、侧支循环等机制可能保留了更多的存活心肌）；,即使无缺血症状也不能说明一定不存在存活心肌；,BRAVE-2,试验,:,研究设计,一级终点,:Final left ventricular infarct size according SPECT with,Tc,99m,sestamibi,performed between 5 and 10 days after randomization,二级终点,：,Composite of death,recurrent MI,or stroke at 30 days.,介入治疗组,n=182,保守治疗组,n=183,目标,:,To assess whether an immediate invasive treatment strategy is associated with a reduction of infarct size in patients with acute STEMI,presenting between,12 and 48,hours after symptom onset,vs,a conventional conservative strategy.,设计,:,International,multicenter,open-label,randomized controlled trial conducted from May 23,2001,to December 15,2004.,365,patients aged 18 to 80 years without persistent symptoms admitted with the diagnosis of acute STEMI between 12 and 48 hours after symptom onset were randomized.,JAMA.2005;293:2865-2872.,BRAVE-2,试验,:,一级终点,JAMA.2005;293:2865-2872.,BRAVE-2,试验,:,二级终点,JAMA.2005;293:2865-2872.,BRAVE-2,试验,:,总结,对于心梗,12-48,小时,的无症状患者，急诊,PCI,手术相较于药物保守治疗能明显减少梗死心肌范围；,在,30,天临床终点事件方面（死亡、再发心梗、卒中），急诊,PCI,手术与药物保守治疗相比无差别；,造影发现，这些患者中,TIMI 0,血流仅占,27%,，其余,73%,存在前向血流或侧支循环。JAMA.2005;293:2865-2872.,Danish,研究,Myocardial perfusion imaging(MPI)was performed acutely to assess area at risk(AAR)before angioplasty and repeated after 30 days to assess FIS(%of LV myocardium),salvage index(%non-infarcted AAR),and left ventricular ejection fraction(LVEF).,Early presenters,(n=341),PCI 12 hours,after symptom onset,late presenters,(n=55),PCI between 12 and 72 hours,after symptom onset,396,例,STEMI,病人,European Heart Journal(2009)30,13221330,Danish Study,European Heart Journal(2009)30,13221330,Early,(N=341),Late,(N=55),P Value,AAR(%),28(18-40),31(22-45),0.04,Salvage Index(%),69(45-91),53(27-89),0.05,LVEF(%),52(47-59),48(44-58),0.04,LVEDV(ml),115(92-138),121(99-146),0.27,LVESV(ml),53(39-70),57(45-80),0.10,1-year Mortality,0.9,3.6,0.05,Eur,Heart J 2006;27:19001907,Primary PCI is recommended for the treatment of STEMI in patients presenting with symptoms for less than 12 hours,Antman EM et al.,AHA/ACC STEMI guidelines 2007:,Circulation,2008;117:296-329.,Background,Primary PCI is recommended for the treatment of STEMI in patients presenting with symptoms for less than 12 hours,Antman EM et al.,AHA/ACC STEMI guidelines 2007:,Circulation,2008;117:296-329.,However,8.5-40%of STEMI-patients are ”late presenters”with symptoms for more than 12 hours on admission,Schomig A et al.,Eur Heart J,2006;27:1900-1907,Background,BRAVE-2 is the only trial on,primary,angioplasty vs.medical therapy in STEMI-patients with symptoms for 12-48 hours on admission,Schomig A et al.,JAMA,2005293:2865-2872,Parodi G et al.,Am Heart J,2006;152:1133-1139,Background,BRAVE-2 is the only trial on,primary,angioplasty vs.medical therapy in STEMI-patients with symptoms for 12-48 hours on admission,Schomig A et al.,JAMA,2005;293:2865-2872,Parodi G et al.,Am Heart J,2006;152:1133-1139,Final infarct size:,Primary PCI vs.Medical therapy:p0.001,Background,8%,13%,BRAVE-2 is the only trial on,primary,angioplasty vs.medical therapy in STEMI-patients with symptoms for 12-48 hours on admission,Schomig A et al.,JAMA,2005;293:2865-2872,Parodi G et al.,Am Heart J,2006;152:1133-1139,Salvage index(%of risk area salvaged):,Primary PCI vs.Medical therapy:p0.001,Background,44%,23%,To evaluate if the 12-hour limit is a relevant cut-off point for offering primary angioplasty,Aim,Late presenters(12-72 h)do,not,achieve myocardial salvage after primary angioplasty and therefore develop larger final infarct sizes than early presenters(12 h),Hypothesis,Symptom duration was defined as time from onset of symptoms to first balloon inflation=,pain-to-balloon interval,Definition of symptom duration,Myocardial scintigraphy,before primary PCI:,Myocardial scintigraphy,30 days later:,Salvage=46-5 =41%of LV myocardium,Salvage index,=41/46=,89%of area at risk,Area at risk=46%,Infarct size=5%,Method:Myocardial scintigraphy,1),Ndrepepa,G,J,Nucl,Med 2004;45:725-729;,2)Burns RJ,JACC 2002;39:30-6,Primary outcome:Infarct size(%of LV),Power calculation,*,:,12 h:,Infarct size=15,10%:,n=200,12-72 h:,Infarct size,=2010%:,n=60,(Clinicaltrials.gov,study no.NTC00260416),*,2,=0.05,=0.20(power=0.80),Study design,From May 1,2005 to April 26,2007 we used a,uniform treatment protocol,for all STEMI-patients presenting between 30 minutes and 72 hours after onset of symptoms:,Aspirin,clopidogrel,heparin,immediate transfer to the cath.lab.,primary angioplasty with stent implantation,and infusion of abciximab,Study design,Pain-to-balloon interval 2 mV(ECG-12),or,New Q-waves&TnT 0.1,g/l,Inclusion criteria,PCI within previous 30 days,Previous CABG,Left main stenosis,Peak troponin T 0.1,g/l,Risk area 5%of LV,Re-infarction,re-PCI or CABG during follow-up,Thrombectomy,Exclusion criteria,Consent,n=619,Inclusion,n=415,Exclusion,n=204,By criteria,n=152,No final scintigraphy,n=52,(6 deaths),12 hours,n=360,12-72 hours,n=55,Patient inclusion,12 h(n=360),12-72 h(n=55),p,Women(%),25,33,0.24,Age(y),62,12,63,10,0.84,Diabetes(%),9,4,0.18,Hypertension(%),32,31,0.84,Hypercholesterolaemia(%),19,9,0.19,Previous AMI(%),7,0,0.04*,Median BMI(kg/m),26(IQR 24-29),26(IQR 24-29),0.67,Smoker(%),56,50,0.39,Anterior STEMI(%),43,55,0.11,Multi vessel disease(%),41,49,0.23,Pre-PCI TIMI 0(%),60,56,0.76,Pre-PCI TIMI 1(%),6,9,Pre-PCI TIMI 2(),11,13,Pre-PCI TIMI 3(%),23,22,Post-PCI TIMI 3(%),91,87,0.45,Filter wire protection(%),36,5,0.001*,Abciximab(Reopro)(%),96,98,0.44,Baseline characteristics,*,No impact on primary endpoint,Primary outcome:Infarct size,Linear regression:,p0.001,R,=0.05,6%14%p=0.002,(1-17)(3-30),(n=415),Symptom duration(h),Infarct size(%of LV),Area at risk,25%31%p=0.005,(15-39)(22-45),Linear regression:,p=0.008,R,=0.03,(n=262),Symptomvarighed(t),Area at risk(%af LV),Symptom duration(h),Area at risk(%of LV),Salvage index,69%53%p=0.06,(45-92)(27-89),Linear regression:,p=0.02,R,=0.02,(n=262),Salvage/AAR(%),Symptomvarighed(t),Symptom duration(h),Symptomvarighed(t),Infarkt-strrelse(%af LV),Linear regression:,p0.001,R,=0.07,11%20%p=0.009,(3-21)(7-35),(n=248),Symptom duration(h),Total occlusion subgroup:,Infarct size,Infarct size(%of LV),Symptomvarighed(t),Salvage/AAR(%),57%44%p=0.03,(42-86)(23-73),Linear regression:,p=0.01,R,=0.05,Total occlusion subgroup:,Salvage index,(n=154),Symptom duration(h),Time-to-treatment in primary PCI,does,matter:Infarct size increases and salvage index decreases(”time is muscle”)in the interval 0-72 hours,Conclusions,Time-to-treatment in primary PCI,does,matter:Infarct size increases and salvage index decreases(”time is muscle”)in the interval 0-72 hours,Substantial salvage is observed despite symptom durations of 12-72 hours,even when the infarct-related artery is totally occluded,Conclusions,Time-to-treatment in primary PCI,does,matter:Infarct size increases and salvage index decreases(”time is muscle”)in the interval 0-72 hours,Substantial salvage is observed despite symptom durations of 12-72 hours,even when the infarct-related artery is totally occluded,Latecomers should be considered for primary PCI,Conclusions,对乡村地区预期由于长距离转运而造成时间延误的,STEMI,病人采用药物,-,介入治疗策略的安全性和有效性研究,结论,:,For STEMI pts facing long delays to a PCI center,half-dose,lytic,therapy plus immediate transfer for PCI is a safe alternative to primary PCI.,2,634 pts received either primary PCI or half-dose,fibrinolytic,plus immediate transfer for PCI,depending on distance from PCI center.,Larson DMet al.,Eur,Heart J,.,2011;Epub ahead of print.,30-Day Outcomes,Primary PCI,(n=1,763),Pharmaco-,Invasive,(n=692),P,Value,Mortality,5.6%,5.8%,0.87,Recurrent Ischemia/MI,1.5%,1.3%,0.67,TIMI Major Bleeding,1.4%,1.6%,0.76,European Heart Journal(2010)31,25012555,从症状开始起,12-24,小时，甚至可能至,60,小时的病人，即使疼痛缓解，血流动力学稳定，也有可能从早期冠脉造影及可能的,PCI,中获益。,总 结,重视心梗后,12-72,小时就诊的患者，即使没有症状，不说明没有存活心肌，,急诊,PCI,治疗可能获益；,尽可能应用血栓抽吸、,IIb/IIIa,拮抗剂等手段，减少无复流现象，挽救更多心肌；,如果由于转运造成时间延误，可以采用药物,-,介入治疗策略以挽救心肌；,急诊,PCI,队伍可能面临更大的压力；,Thank You!,