高润霖-冠心病介入治疗的热点.ppt
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1、冠心病介入治疗的热点-2008,中国医学科学院阜外心血管病医院 高润霖,DES的安全性和长期疗效 新一代DES,From TCT 2006,From TCT 2006,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I, II, IV, V, VI (n=3,513),RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n=1,748),Stone GW et al. NEJM 2007;356:998-1008,9 Prospective, Double-
2、Blind, Randomized Trials Freedom From (Protocol) Stent Thrombosis,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I, II, IV, V, VI (n=3,513),RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n=1,748),Stone GW et al. NEJM 2007;356:998-1008,9 Prospective, Double-Blind, Randomized
3、Trials Freedom From (Protocol) Stent Thrombosis,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I, II, IV, V, VI (n=3,513),RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748),P=0.23,94.7% (45),93.3% (57),Stone GW et al. NEJM 2007;356:998-1008,P=0.68,93.4% (92),93.9% (86),9 Pr
4、ospective, Double-Blind, Randomized Trials Freedom From All Cause Death,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I, II, IV, V, VI (n=3,513),RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748),P=0.86,93.8% (53),93.6% (55),Stone GW et al. NEJM 2007;356:998-1008,P=0.66,93
5、.7% (105),93.0% (115),9 Prospective, Double-Blind, Randomized Trials Freedom From Myocardial Infarction,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I, II, IV, V, VI (n=3,513),RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748),P0.0001,76.4% (202),92.2% (66),Stone GW et al
6、. NEJM 2007;356:998-1008,P0.0001,80.0% (338),89.9% (166),9 Prospective, Double-Blind, Randomized Trials Freedom From Ischemic TLR,ARC Proposed Standard Definitions,Definite/Confirmed Acute coronary syndrome AND Angiographic confirmation of thrombus or occlusion OR Pathologic confirmation of acute th
7、rombosis Probable Unexplained death within 30 days Target vessel MI without angiographic confirmation of thrombosis or other identified culprit lesion Possible Unexplained death after 30 days,NOTE: Patients who have a TLR prior to a thrombosis are included by this set of definitions, as opposed to t
8、he “Per Protocol” definition,Stent Thrombosis: FDA Advisory Panel, 8RCT,Mauri, L. N Engl J Med 2007;356:1020-9.,definite and probable,definite and probable,1.2% 0.6%,1.7% 1.5%,1.3% 0.8%,1.8% 1.4%,When DES are used for their approved indications, the risk of thrombosis does not outweigh their advanta
9、ges over BMS in reducing TLR As compared with on-label use, off-label use is associated with increased risks of both early and late stent thrombosis,as well as death or MI,RCT荟萃分析显示,死亡、MI,不论on-label或off-label应用,在DES与BMS组均无显著差别;TVR则不论on-label或off-label应用 DES均明显低于BMS 30 项研究 174,302患者真实世界注册研究则显示,全因死亡、M
10、I在DES组均明显低于BMS DES的长期安全性及有效性已得到临床试验及真实世界研究证实,Conclusions (1),In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for 1 yr, DES resulted in: Non significant 3% and 6% reductions in mortality and MI respectively A highly significant 55% reduction in TVR In 30 registries in which 1
11、74,302 pts were treated with either DES or BMS and followed for 1 yr, DES resulted in: A highly significant 20% reduction in mortality A significant 11% reduction in MI A highly significant 47% reduction in TVR,Conclusions (2),The favorable results of DES from the RCT and registry analysis populatio
12、ns were robust and consistent for both on-label and off-label use, and for clinical f/u extending to 3-4 years,These findings, derived from more than 180,000 pts treated in 52 studies, strongly suggest that DES are safe for both on-label and off-label use, and have comparable efficacy in both RCTs a
13、nd in the “real-world”,A 65-year old male with CAD, hypertension, MI, Status post x2 stents, RCA, proximal BxVelocity and Cypher distal - 15 months prior to death (traumatic brain injury),BxVelocity,Cypher,Fibrin,No endothelialization,From Dr.R.Vermani,Discontinuation of Anti-platelet Therapy and Ri
14、sk for ST,Incidence (%),Iakovou et al. JAMA. 2005;293:2126.,Overall stent thrombosis = 1.3% (P=0.09, N=2229),How long should dual antiplatelet therapy continue?,?,双重抗血小板治疗至少一年 不适宜DES置入的情况 计划中的非心脏手术 不适宜长期双重抗血小板治疗 置入DES后必须行非心脏手术者 尽量不停阿斯匹林 术后尽早恢复氯吡格雷治疗 教育病人家属,与相关医师沟通、必要时咨询心脏科医生,不适宜长期双重抗血小板治疗的情况,计划中的非心脏
15、手术 支架血栓形成的高危患者 出血并发症风险增加 高龄,贫血,肾功能衰竭,消化道出血后, 低体重 需长期服口服抗凝剂者 房颤、肺栓塞、机械瓣置换术后 不愿意或不能长期按医嘱服药者,Summary,Long-term efficacy of DES is persistent and the safety of DES is confirmed by meta-analysis based on patients level Late stent thrombosis after DES implantation has emerged as a concerning entity Indica
16、tion for DES stenting Proper dual antiplatelet therapy, at least 1year Technical improvement of DES and new type of DES are emerging and promising,010300jt-os.ppt - On-screen 45,Acute Myocardial Infarction,Emerging role of aspiration thrombectomy in a large trial from Europe,TAPAS Trial: 1071 STEMI
17、patients randomized,535 were assigned to thrombus aspiration,33 did not undergo PCI 502 underwent primary PCI 295 underwent TA followed by direct stenting 153 underwent TA with additional balloon dilation 54 had crossover to conventional PCI,536 were assigned to conventional PCI,33 did not undergo P
18、CI 503 underwent primary PCI 485 underwent balloon dilation followed by stenting 12 underwent conventional PCI with additional TA 6 had crossover to TA,530 complete follow-up at 1 year,530 complete follow-up at 1 year,Ziljstra et al, NEJM 2008,TAPAS Primary endpoint Myocardial blush grade,P 0.001,Pa
19、tients (%),Thrombus aspiration,Conventional PCI,Ziljstra et al, NEJM 2008,TAPAS: Mortality at 1 year,Log-Rank p = 0.040,*Unpublished results,Ziljstra et al, NEJM 2008,TAPAS: Mortality or non-fatal ReMI at 1 year,Log-Rank p = 0.016,*Unpublished results,Ziljstra et al, NEJM 2008,Take Home Message,Unli
20、ke earlier studies with aggressive rheolytic thrombecomy, the mild aspiration thrombectomy had significant angiographic and clinical benefit in patients with STEMI having PCI,在稳定性CAD患者中, 哪些患者更能从PCI获益,?,AMI: Pathophysiology,Ruptured plaque with occlusive thrombus,23 Randomized Trials of PCI vs. Lysis
21、,P0.0001,N = 7,739,Keeley, Grines. Lancet 2003;361:13-20,P0.0001,p=0.0002,p=0.0002,ACS: Pathophysiology,Ruptured plaque with subocclusive thrombus,Mehta SR et al. JAMA 2005;293:2908-2917,Composite of Death or Myocardial Infarction No./Total (%),Odds Ratio (95% Cl),Favors Routine Invasive,Favors Sele
22、ctive Invasive,OR, 0.82 0.72-0.93 P0.001,Meta-analysis of Conservative vs. Invasive Strategies in ACS,9,212 randomized pts in 7 trials Composite death or MI from rand to latest FU,18%,Meta-analysis of Conservative vs. Invasive Strategies in ACS,Mehta SR et al. JAMA 2005;293:2908-2917,CCS Class III-I
23、V Angina,Rehospitalization,Odds Ratio (95% Cl),OR, 0.77 0.68-0.87 P0.001,0.1,1.0,10,0.1,1.0,10,OR, 0.66 0.60-0.72, P0.001,Favors Routine Invasive,Favors Selective Invasive,23%,34%,Stable Coronary Artery Disease,Fibrotic plaque,COURAGE: Study design,Boden WE et al. Am Heart J. 2006;151:1173-9. Boden
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