超过再灌注治疗时间窗的STEMI患者的介入治疗策略选择.ppt

1、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, Muscl

2、e 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 incr

3、eased 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

4、: 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,

5、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;3

6、55:23952407.,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,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（

7、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 as

8、sess 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

9、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

10、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)

11、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,3

12、96 例 STEMI病人,European Heart Journal (2009) 30, 13221330,Danish Study,European Heart Journal (2009) 30, 13221330,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

13、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” wit

14、h 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 2005;293:2865-2872 Parodi G et al., Am He

15、art 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 t

16、herapy: 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

17、 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 pres

18、enters (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 i

19、ndex = 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 = 1510%:n=200 12-72 h:Infarct size = 2010%:n=60 (C, study no. NTC00260416) *2=0.05, =0.20 (power=0.80),Study design,From May