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1、Highlights of Advances in PCI -2008,Runlin Gao, MD, FACC Cardiovascular Institute and Fu Wai Hospital, Beijing, China,2008年5月29日，Shanghai,From TCT 2006,From TCT 2006,Long-Term Safety and Efficacy of DES and New Generation of DES,Time after Initial Procedure (years),Time after Initial Procedure (year
2、s),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 Trials Freedom From (Protocol) Stent Thrombosis,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I, II, IV
3、, 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 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),
4、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 Prospective, Double-Blind, Randomized Trials Freedom From All Cause Death,Time after Initial Procedure (years),Time after Initial Procedure (years),TAXUS I,
5、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=0.66,93.7% (105),93.0% (115),9 Prospective, Double-Blind, Randomized Trials Freedom From Myocardial Infarction,Time after Initial Procedure (years),Time after Ini
6、tial 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. 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 Def
7、initions,Definite/Confirmed Acute coronary syndrome AND Angiographic confirmation of thrombus or occlusion OR Pathologic confirmation of acute thrombosis Probable Unexplained death within 30 days Target vessel MI without angiographic confirmation of thrombosis or other identified culprit lesion Poss
8、ible 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 the “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
9、,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 advantages 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 wel
10、l as death or MI,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 174,302 pts were treated with
11、 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 populations were robust and consisten
12、t 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 and in the “real-world”,A 65-
13、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 Risk for ST,Incidence (%),Iako
14、vou 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,计划中的非心脏手术 支架血栓形成的高危患者 出血并发症风险增加 高龄，
15、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 Indication for DES stenting Proper
16、 dual antiplatelet therapy, at least 1year Technical improvement of DES and new type of DES are emerging and promising,010300jt-os.ppt - On-screen 44,Strategy of Bifurcation Lesions,Crush-stenting,Vs. Culotte-stenting,NORDIC Trial,Gunnes et al, SCAI-ACCi2 2008,NORDIC Tiral Randomization (n= 424),CRU
17、SH (n: 209),CULOTTE (n: 215),Clinical Follow up, 6 months (n: 209),Clinical Follow up, 6 months (n: 215),Scheduled Angiographic Follow up, 8 months (n: 184),Scheduled Angiographic Follow up, 8 months (n:189),Angiographic FU available (n: 160),Angiographic FU available (n: 164),n: 424 (100%),n: 424 (
18、100%),n: 373 (88%),n: 324 (87%),Stratification at randomization,Gunnes et al, SCAI-ACCi2 2008,Gunnes et al, TCT 2007,NORDIC: Localization of in-stent restenosis at 8 months follow-up,CRUSH,CULOTTE,0.0%,0.0%,2.0%,0.6%,9.8%*,3.8%*,* p=0.04,Gunnes et al, SCAI-ACCi2 2008,CHRUSH,CULOTTE,2.0%,0.0%,0.7%,1.
19、3%,2.0%,1.3%,NORDIC: Localization of edge restenosis at 8 months follow-up,Gunnes et al, SCAI-ACCi2 2008,Take Home Message,Bifurcation stenting requires a meticulous technique with excellent dilation of the side-branch,Left Main Coronary Disease: CABG vs PCI,010300jt-os.ppt - On-screen 59,January, 2
20、000 Second quarter (May), 2003 June, 2006,Wave I,LMCA disease,BMS (N=318),CABG (N=448),Wave II,LMCA disease,DES (N=784),CABG (N=690),MAIN-COMPARE Study Stenting (BMS or DES) vs. CABG,PCI (N=1102),CABG(N=1138),Total (N=2240),Park SJ, SCAI-ACCi2 2008,MAIN-COMPARE Mortality,(BMS and contemporary CABG m
21、atched cohort: 207pairs),Park SJ, SCAI-ACCi2 2008,MAIN-COMPARE Target-vessel revascularization,(BMS and contemporary CABG matched cohort: 207pairs),Park SJ, SCAI-ACCi2 2008,Take Home Message,Left main stenting is feasible and in the Main-Compare study from Korea appeared very similar to CABG surgery
22、 at 3 year follow-up.,Interventions for STEMI,010300jt-os.ppt - On-screen 64,TRANSFER-AMI Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction,Objective: Determine the efficacy and safety of routine PCI within 6 hours of fibrinolysis amon
23、g high risk STEMI patients presenting to non-PCI facilities,Background: The ASSENT-4 trial showed that STEMI patients treated with early facilitated PCI experienced more major adverse events than PCI alone,PCI Centre Cath Lab,Community Hospital ED,Cath/PCI within 6 hrs regardless of reperfusion stat
24、us,Cath and Rescue PCI GP IIb/IIIa Inhibitor,TNK + ASA + Heparin or Enoxaparin + Clopidogrel,Pharmacoinvasive Strategy,Assess chest pain, ST resolution 60-90 minutes after randomization,High Risk ST Elevation MI within 12 hours of symptom onset,Failed Reperfusion,Successful Reperfusion,Elective Cath
25、 PCI 24 hrs later,Standard Treatment,Repatriation of stable patients within 24 hrs of PCI,Randomization,Cantor et al, ACC/i2 2008,Urgent Transfer to PCI Centre,Treatment,Medical Therapies TNK Heparin or Enoxaparin in pts 75 yrs of age ASA 160-325 mg Clopidogrel 300mg bolus (75 mg if 75 years of age)
26、 All other meds as per ACC/AHA STEMI guidelines,PCI PCI of culprit lesion if 70% stenosis or 50-70% stenosis with high-risk features (thrombus, ulceration, spontaneous dissection) Stents used whenever technically possible GP IIb/IIIa inhibitors left to operators discretion,Cantor et al, ACC/i2 2008,
27、0,2,4,6,8,10,12,14,16,18,0,5,10,15,20,25,30,10.6,16.6,Days from Randomization,% of Patients,n=496 n=508,422 468,415 466,415 463,414 461,414 460,412 457,OR=0.537 (0.368, 0.783); p=0.0013,Primary Endpoint: 30-day combined death, re-MI, CHF, severe recurrent ischemia, shock,Cantor et al, ACC/i2 2008,Co
28、mponents of Primary Endpoint,Death Reinfarction Recurrent Ischemia New/worsening CHF Cardiogenic Shock Death/MI/Ischemia,Standard Treatment (n=498) 3.6 6.0 2.2 5.2 2.6 11.7,Pharmaco -invasive (n=512) 3.7 3.3 0.2 2.9 4.5 6.5,P 0.94 0.044 0.019 0.069 0.11 0.004,Safety Endpoints,Intracranial hemorrhage
29、 TIMI scale Major Major (non-CABG-related) GUSTO scale Severe Severe (non-CABG-related) Transfusions,Standard Treatment (n=498) 1.2 4.6 3.2 1.4 1.2 5.5,Pharmaco- invasive (n=512) 0.2 4.3 2.2 0.6 0.6 7.1,P 0.066 0.88 0.33 0.22 0.34 0.31,Cantor et al, ACC/i2 2008,Take Home Messages,High-risk STEMI pat
30、ients treated with fibrinolysis who undergo PCI within 6 hours have lower rates of adverse ischemic outcomes without significant increase in bleeding risk Transfer should be initiated as soon as possible without awaiting results of fibrinolysis Benefit seen in the setting of clopidogrel loading and
31、glycoprotein IIb/IIIa inhibitor use,Acute Myocardial Infarction,Emerging role of aspiration thrombectomy in a large trial from Europe,TAPAS Trial: 1071 STEMI patients randomized,535 were assigned to thrombus aspiration,33 did not undergo PCI 502 underwent primary PCI 295 underwent TA followed by dir
32、ect stenting 153 underwent TA with additional balloon dilation 54 had crossover to conventional PCI,536 were assigned to conventional PCI,33 did not undergo PCI 503 underwent primary PCI 485 underwent balloon dilation followed by stenting 12 underwent conventional PCI with additional TA 6 had crosso
33、ver 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,Patients (%),Thrombus aspiration,Conventional PCI,Ziljstra et al, NEJM 2008,TAPAS: Mortality at 1 year,Log-Rank p = 0.040,*Unpublished results,Z
34、iljstra 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,Unlike earlier studies with aggressive rheolytic thrombecomy, the mild aspiration thrombectomy had significant angiographic and clinical benefit i
35、n patients with STEMI having PCI,CONCLUSION,Long-term efficacy of DES is persistent and the safety of DES is confirmed by meta-analysis of randomized trials based on patients level and registries. New type of DES are emerging and promising Technical approach improved clinical efficacy Percutaneous intervention for AMI is still progressing,Thank you,