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1、,Keith A A Fox心脏病学教授英国心脏病学会主席,英国爱丁堡大学心血管病研究中心,遵循指南、提高ACS诊治水准:GRACE注册研究的启示,关于GRACE?,迄今最大的多国、多中心、前瞻性、观察性队列研究来自14个国家、113家医院 不同医院能反映ACS的整个疾病谱病人入选避免偏倚因素培训、质量控制、监察102,341例ACS患者 18 岁ACS不受非心脏性共患因素影响出院后随访至6个月(有随访2年的临床亚研究)随访一直持续到2009年12月31号,www.outcomes.org/grace,主要的临床结局,院内主要临床结局 死亡 再发心梗 卒中 充血性心力衰竭 肺水肿 心源性休克
2、随访6个月临床结局 死亡 心梗 卒中,Fox KAA,et al.JAMA.2007;297:1892-1900.,GRACE回答了哪些特殊问题？,ACS患者在随访期间临床终点事件的发生率和发生时间?旨在提高临床诊治水平的措施是否改变了患者治疗和临床结局?强化治疗措施是否增加了出血风险?危险分层评估能否最大程度地使患者获益?,ST 段抬高,ST 段压低,无ST段改变,Kaplan Meier累计死亡曲线:按照ST段改变分组,ACS患者临床事件的发生时间:从入院到15天,Fox KAA et al Nature clin practice 2008;5:580-9,ST 段抬高,ST段压低,无S
3、T段变化,HR 0.85,95%CI 0.750.97 P=0.02ST段抬高 vs ST段压低,Fox KAA et al Nature clin practice 2008,5;580-9,Kaplan Meier累计死亡曲线:按照ST段改变分组,ACS患者临床事件的发生时间:15天(Landmark分析),重要结果:无论ST段抬高或是非抬高的ACS患者，GRACE评分最高者较评分最低者死亡率升高1040倍(P 0.0001).多数死亡发生在最初4天:ST段抬高，57%ST段压低，74%无ST段变化，78%,Fox KAA et al Nature clin practice 2008,5
4、;580-9,ACS患者治疗和临床结局变化的时间倾向,GRACE注册研究中采用的提高诊治水准措施当地人员培训质量控制和审计监察当地数据的反馈，并作国内和国际间的比较衡量临床实践和临床结局改善的措施介入治疗比例的增加双重或三重抗血小板治疗抗凝治疗,GRACE季度报告的摘取,至关重要的问题,临床实践是如何改变的?对于死亡、心梗（再发心梗）的影响如何?对于心衰的影响如何?获益是否以带来更高出血风险为代价？,STEMI治疗模式的改变,Fox KAA,et al.JAMA.2007;297:1892-1900.,GRACE data(N=44,372),P 0.001,P 0.001,P 0.001,P
5、 0.001,P 0.001,P 0.001,P=NS,ST段抬高型或非ST段抬高型ACS患者接受PCI和CABG治疗,住院期间使用肝素STEMI,非ST段抬高型ACS的治疗模式改变,Fox KAA,et al.JAMA.2007;297:1892-1900.,GRACE data(N=44,372),P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,住院期间使用肝素NSTE ACS,GRACE危险评分：STEMI/左束支传导阻滞（LBBB）,Fox KAA,et al.JAMA.2007;297:1892-1900.,死亡、再发心
6、梗：STEMI,P for trend=0.019,P for trend=0.001,死亡,再发心梗,出血：STEMI,P for trend=0.029,死亡：NSTE ACS,P for trend=0.033,死亡,再发心梗：NSTE ACS,P for trend=0.001,P for trend=0.033,死亡,再发心梗,大出血：NSTE ACS,P for trend=0.0004,住院期间临床结局的改变,*呈线性趋势 P 0.001：死亡、充血性心力衰竭/肺水肿;*P 0.01：心梗,*,*,*,*,*,Fox KAA,et al.JAMA.2007;297:1892-19
7、00.,大出血的影响：有 vs 无死亡和再发心梗的危险比(OR),大出血的影响：有 vs 无死亡和再发心梗的危险比(OR),对ACS患者你是否应当用危险分层评估?,Guidelines for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes.European Heart Journal(2007)28,15981660.doi:10.1093/eurheartj/ehm161,www.nice.org.uk,Acute Coronary Syndromes(in consultat
8、ion),ESC Guideline 2007,GRACE发现与问题：讨论,自1999至2009年以来，STEMI和非ST段抬高型ACS的临床诊治发生了实质性的改变；这些变化与临床研究证据和指南推荐相一致；已观察到：新发的心衰、死亡率以及出院后卒中和心梗的发生率有了显著的下降；与指南相违背的是，现实临床实践中病人仍未按危险分层评估给予相应诊治措施，这一问题是国际普遍化的。,出血风险有何影响?,尽管血管造影和PCI日渐普及、更多强有力的抗栓治疗药物应用，大出血的发生率还是呈下降趋势的；大出血的影响：使院内死亡率增加35倍，再发心梗的发生率增加23倍,科学指导委员会,Argentina Enriq
9、ue GurfinkelAustralia/New ZealandDavid BriegerAustria Werner KleinBelgium Frans J Van de WerfBrazil lvaro AvezumCanada Shaun Goodman,Germany Dietrich C GulbaItalyGiancarlo AgnelliFranceGilles MontalescotPh Gabriel StegPolandAndrzej BudajSpain Jos Lpez-Sendn,United KingdomKeith AA FoxMarcus FlatherUn
10、ited StatesFrederick A AndersonKim A EagleRobert J GoldbergMichael E HowardJoel M GoreChristopher B GrangerBrian M Kennelly,ChairsKeith AA Fox,UKJoel M Gore,USA,Publications Kim A Eagle,USACo-Chairs Ph Gabriel Steg,France,Study Co-ordination Fred Anderson,University of Massachusetts,Keith A A FoxPro
11、fessor of CardiologyPresident:British Cardiovascular Society,Edinburgh Centre for Cardiovascular Science,Potential Implications of Quality Improvement in Guideline Therapy for ACS:What have we learnt from GRACE?,What is GRACE?,Largest multinational observational prospective cohort study113 hospitals
12、 in 14 countries Clusters of hospitals reflecting full spectrum of ACSUnbiased patient inclusionTraining,quality control and audit102,341 ACS patients 18 years oldACS not precipitated by a noncardiovascular comorbidityFollow-up at 6 months post discharge(subset at 2 years)Follow-up to December 31,20
13、09,www.outcomes.org/grace,Main Outcome Measures,Inhospital outcomes Death Recurrent MI Stroke Congestive heart failure Pulmonary edema Cardiogenic shock Six-month outcomes Death MI Stroke,Fox KAA,et al.JAMA.2007;297:1892-1900.,Specific Questions addressed by GRACE,Incidence and time course of outcom
14、e events following ACS?Have quality improvement measures changed therapy and outcomes?Has more intensive therapy increased the frequency of bleeding?Can risk scores define populations with greatest potential for benefit?,ST elevation,ST depression,No ST deviation,Kaplan Meier Cumulative Death rate:b
15、y ST Group,Time course of events in ACS:admission to 15 days,Fox KAA et al Nature clin practice 2008;5:580-9,ST elevation,ST depression,No ST deviation,HR 0.85,95%CI 0.750.97 P=0.02ST elevation vs ST depression,Fox KAA et al Nature clin practice 2008,5;580-9,Kaplan Meier Cumulative Death rate:by ST
16、Group,Time course of events in ACS:beyond 15 days(landmark analysis),Key findings:Within each ST category,highest GRACE risk scores had a 1040-fold greater risk of death than lowest scores(P 0.0001).Most deaths occurred after the first 4 days:ST-segment elevation 57%ST-segment depression 74%No ST-se
17、gment deviation 78%,Fox KAA et al Nature clin practice 2008,5;580-9,Time Trends in Therapy and Outcome in ACS,Quality improvement measures in GRACELocal training of personnelQuality control and auditFeedback of local data,national and international comparisonsMeasurement of practice patterns and out
18、comesIncreased use of interventional proceduresDual or triple antiplatelet therapyAnticoagulants,Extract from GRACE Quarterly Report,Critical Questions,How has practice changed?What is the impact on death and MI(recurrent MI)?What is the impact on heart failure?Have the benefits occurred at the cost
19、 of more major bleeding?,Changes in Therapy for STEMI,Fox KAA,et al.JAMA.2007;297:1892-1900.,GRACE data(N=44,372),P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,P=NS,PCI and CABG by Presence Or Absence of ST Elevation,Heparins In-hospitalSTEMI,Changes in Therapy for NSTE ACS,Fox KAA,et al.JAMA.2007
20、;297:1892-1900.,GRACE data(N=44,372),P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,P 0.001,Heparins In-hospitalNSTE ACS,GRACE Risk Scores for STEMI/LBBB,Fox KAA,et al.JAMA.2007;297:1892-1900.,Death,ReMISTEMI,P for trend=0.019,P for trend=0.001,Death,ReMI,BleedingSTEMI,P for trend=0.029,DeathNSTE A
21、CS,P for trend=0.033,Death,ReMINSTE ACS,P for trend=0.001,P for trend=0.033,Death,ReMI,Major BleedingNSTE ACS,P for trend=0.0004,Change in In-hospital Outcomes,*P for linear trends 0.001 for death and CHF/pulmonary edema;*P 0.01 for MI,*,*,*,*,*,Fox KAA,et al.JAMA.2007;297:1892-1900.,Impact of Major
22、 Bleed vs.None Odds Ratios for Death&ReMI,Impact of Major Bleed vs.None Odds Ratios for Death&ReMI,Should you use a risk score in ACS?,Guidelines for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes.European Heart Journal(2007)28,15981660.doi:10.1093/eurheartj/ehm161,
23、www.nice.org.uk,Acute Coronary Syndromes(in consultation),ESC Guideline 2007,Findings and Points for Discussion,Substantial changes in management of STEMI and NSTE ACS have occurred between 1999 and 2009These changes are consistent with trial evidence and guidelinesSignificant reductions were observ
24、ed in the rates of new heart failure,mortality,and for post-discharge stroke and MIIn contrast to Guidelines,patients in practice are not yet managed(internationally)according to risk status,What is the impact on bleeding?,Declining rates of major bleeding despite higher use of angiography and PCI,a
25、nd more aggressive antithrombotic therapiesRisk of inhospital death increased 3 5 fold with major bleeding and reMI increased 2 3 fold,Scientific Advisory Committee,Argentina Enrique GurfinkelAustralia/New ZealandDavid BriegerAustria Werner KleinBelgium Frans J Van de WerfBrazil lvaro AvezumCanada S
26、haun Goodman,Germany Dietrich C GulbaItalyGiancarlo AgnelliFranceGilles MontalescotPh Gabriel StegPolandAndrzej BudajSpain Jos Lpez-Sendn,United KingdomKeith AA FoxMarcus FlatherUnited StatesFrederick A AndersonKim A EagleRobert J GoldbergMichael E HowardJoel M GoreChristopher B GrangerBrian M Kennelly,ChairsKeith AA Fox,UKJoel M Gore,USA,Publications Kim A Eagle,USACo-Chairs Ph Gabriel Steg,France,Study Co-ordination Fred Anderson,University of Massachusetts,
