高润霖冠心病介入治疗的热点

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1、 冠心病介入治疗的热点冠心病介入治疗的热点-2008 -2008 中国医学科学院阜外心血管病医院中国医学科学院阜外心血管病医院高润霖高润霖 DESDES的安全性和长期疗效的安全性和长期疗效 新一代新一代DESDESFrom TCT 2006From TCT 2006Time after Initial Procedure (years)Time after Initial Procedure (years)0 01 12 23 34 4Time after Initial Procedure (years)Time after Initial Procedure (years)TAXUS I,

2、 II, IV, V, VITAXUS I, II, IV, V, VI(n=3,513)(n=3,513)RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS(n=1,748)(n=1,748)CYPHER stent (n=870) Bare metal stent (n=878)Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-10080 01 12 23 34 4TAXUS stent (n=1,7

3、55) Bare metal stent (n=1,758)9 9 Prospective, Double-Blind, Randomized TrialsFreedom From (Protocol) Freedom From (Protocol) StentStent Thrombosis ThrombosisP=0.2099.4% (5)98.8% (10)P=0.3099.1% (14)98.7% (20)Time after Initial Procedure (years)Time after Initial Procedure (years)0 01 12 23 34 4Time

4、 after Initial Procedure (years)Time after Initial Procedure (years)TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,513)(n=3,513)RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS(n=1,748)(n=1,748)CYPHER stent (n=870) Bare metal stent (n=878)Stone GW et al. NEJM 2007;356:998

5、-1008Stone GW et al. NEJM 2007;356:998-10080 01 12 23 34 4TAXUS stent (n=1,755) Bare metal stent (n=1,758)9 9 Prospective, Double-Blind, Randomized TrialsFreedom From (Protocol) Freedom From (Protocol) StentStent Thrombosis ThrombosisP=0.2099.4% (5)98.8% (10)P=0.3099.1% (14)98.7% (20)5 vs. 0, P=0.02

6、5After 1 yearAfter 1 year9 vs. 2, P=0.028After 1 yearAfter 1 yearTime after Initial Procedure (years)Time after Initial Procedure (years)0 01 12 23 34 4Time after Initial Procedure (years)Time after Initial Procedure (years)TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,513)(n=3,513)RAVEL, SIRIUS,

7、 E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS(n=1,748)(n=1,748)P=0.2394.7% (45)93.3% (57)CYPHER stent (n=870) Bare metal stent (n=878)Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-10080 01 12 23 34 4P=0.6893.4% (92)93.9% (86)TAXUS stent (n=1,755) Bare metal stent (n=

8、1,758)9 9 Prospective, Double-Blind, Randomized TrialsFreedom From All Cause DeathTime after Initial Procedure (years)Time after Initial Procedure (years)0 01 12 23 34 4Time after Initial Procedure (years)Time after Initial Procedure (years)TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,513)(n=3,5

9、13)RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS(n=1,748)(n=1,748)P=0.8693.8% (53)93.6% (55)CYPHER stent (n=870) Bare metal stent (n=878)Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-10080 01 12 23 34 4P=0.6693.7% (105)93.0% (115)TAXUS stent (n=1,718) B

10、are metal stent (n=1,727)9 9 Prospective, Double-Blind, Randomized TrialsFreedom From Myocardial InfarctionTime after Initial Procedure (years)Time after Initial Procedure (years)0 01 12 23 34 4Time after Initial Procedure (years)Time after Initial Procedure (years)TAXUS I, II, IV, V, VITAXUS I, II,

11、 IV, V, VI(n=3,513)(n=3,513)RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS(n=1,748)(n=1,748)P0.000176.4% (202)92.2% (66)CYPHER stent (n=870) Bare metal stent (n=878)Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-10080 01 12 23 34 4P0.000180.0% (338)89.9%

12、(166)TAXUS stent (n=1,755) Bare metal stent (n=1,758)9 9 Prospective, Double-Blind, Randomized TrialsFreedom From Ischemic TLRFreedom From Ischemic TLRARC Proposed Standard DefinitionsDefinite/ConfirmedAcute coronary syndrome ANDAngiographic confirmation of thrombus or occlusion ORPathologic confirm

13、ation of acute thrombosisProbableUnexplained death within 30 daysTarget vessel MI without angiographic confirmation of thrombosis or other identified culprit lesionPossibleUnexplained death after 30 daysNOTE: Patients who have a TLR prior to a thrombosis are NOTE: Patients who have a TLR prior to a

14、thrombosis are included by this set of definitions, as opposed to the “Per included by this set of definitions, as opposed to the “Per Protocol” definition Protocol” definition Stent Thrombosis: FDA Advisory Panel, 8RCTFDA Advisory Panel, 8RCTMauri, L. N Engl J Med 2007;356:1020-9.definite and proba

15、bledefinite and probable1.2%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 TLRAs compared with on-label use, off-label use is associated with increased risks of both early and late stent thr

16、ombosis,as well as death or MIRCTRCT荟萃分析显示荟萃分析显示, ,死亡、死亡、MI,MI,不论不论on-labelon-label或或off-off-labellabel应用应用, ,在在DESDES与与BMSBMS组均无显著差别组均无显著差别;TVR;TVR则不则不论论on-labelon-label或或off-labeloff-label应用应用 DESDES均明显低于均明显低于BMSBMS30 项研究项研究 174,302患者患者真实世界注册研究则显示真实世界注册研究则显示, ,全因死亡、全因死亡、MIMI在在DESDES组均明显低于组均明显低于BMS

17、BMSDESDES的长期安全性及有效性已得到临床试验及真实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世界研究证实A 65-year old male with CAD, hypertension, MI, Status post x2 A 65-year old male with CAD, hypertension, MI, Status post x2 stentsstents, RCA, , RCA, proximal proximal BxVelocityBxVelocity and and CypherCypher distal - 15 months prior to d

18、eath (traumatic distal - 15 months prior to death (traumatic brain injury) brain injury) BxVelocityNeointimaStrutFibrinCypherFibrinNo endothelializationFrom Dr.R.VermaniDiscontinuation of Anti-platelet Therapy and Risk for STIncidence (%)Iakovou et al. JAMA. 2005;293:2126.Overall stent thrombosis =

19、1.3% (P=0.09, N=2229)Unstable anginaThrombusDiabetes Unprotected left mainBifurcationRenal failurePrior brachy RxPremature antiplateletdiscontdHow long should dual antiplatelet therapy continue?双重抗血小板治疗至少一年双重抗血小板治疗至少一年双重抗血小板治疗至少一年双重抗血小板治疗至少一年不适宜不适宜不适宜不适宜DESDES置入的情况置入的情况置入的情况置入的情况 计划中的非心脏手术计划中的非心脏手术

20、不适宜长期双重抗血小板治疗不适宜长期双重抗血小板治疗 置入置入DES后必须行非心脏手术者后必须行非心脏手术者 尽量不停阿斯匹林尽量不停阿斯匹林 术后尽早恢复氯吡格雷治疗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不适宜长期双重抗血小板治疗的情况不适宜长期双重抗血小板治疗的情况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计划中的非心脏手术支架血栓形成的高危患者支架血栓形成的高危患者出血并发症风险增加出血并发症风险增加 高龄，贫血，肾功能衰竭，消化道出血后，高龄，贫血，肾功能衰竭

21、，消化道出血后， 低体重低体重需长期服口服抗凝剂者需长期服口服抗凝剂者 房颤、肺栓塞、机械瓣置换术后房颤、肺栓塞、机械瓣置换术后不愿意或不能长期按医嘱服药者不愿意或不能长期按医嘱服药者SummaryLong-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 Indic

22、ation for DES stenting Proper dual antiplatelet therapy, at least 1yearTechnical improvement of DES and new type of DES are emerging and promising010300jt-os.ppt - On-screen 45Acute Myocardial InfarctionEmerging role of aspiration thrombectomy in a large trial from EuropeTAPAS Trial: 1071 STEMI pati

23、ents randomized535 were assigned tothrombus aspiration33 did not undergo PCI502 underwent primary PCI295 underwent TA followed bydirect stenting153 underwent TA with additionalballoon dilation 54 had crossover to conventionalPCI536 were assigned toconventional PCI33 did not undergo PCI503 underwent

24、primary PCI485 underwent balloon dilationfollowed by stenting 12 underwent conventional PCIwith additional TA 6 had crossover to TA530 complete follow-up at 1 year530 complete follow-up at 1 yearZiljstra et al, NEJM 2008 TAPAS PrimaryTAPAS Primary endpointendpoint MyocardialMyocardial blushblush gra

25、degradeP 0.001 Patients (%)Thrombus aspirationConventional PCIZiljstra et al, NEJM 2008TAPAS: Mortality at 1 yearTAPAS: Mortality at 1 yearLog-Rank p = 0.040*Unpublished resultsZiljstra et al, NEJM 2008TAPAS: Mortality or non-fatal TAPAS: Mortality or non-fatal ReMIReMI at 1 year at 1 yearLog-Rank p

26、 = 0.016*Unpublished resultsZiljstra et al, NEJM 2008Take Home MessageUnlike earlier studies with aggressive rheolytic thrombecomy, the mild aspiration thrombectomy had significant angiographic and clinical benefit in patients with STEMI having PCI在稳定性在稳定性CADCAD患者中，患者中，哪些患者更能从哪些患者更能从PCIPCI获益获益AMI: P

27、athophysiologyRuptured plaque with occlusive thrombus23 Randomized Trials of PCI vs. 23 Randomized Trials of PCI vs. LysisLysisP0.0001P0.0001N = 7,739Keeley, Grines. Keeley, Grines. LancetLancet 2003;361:13-20 2003;361:13-20P0.0001P0.0001p=0.0002p=0.0002p=0.0002ACS: PathophysiologyRuptured plaque wi

28、th subocclusive thrombusRuptured plaque with subocclusive thrombusMehta SR et al. Mehta SR et al. JAMAJAMA 2005;293:2908-2917 2005;293:2908-2917Composite of Death or Myocardial InfarctionNo./Total (%)SourceSourceRoutine invasiveRoutine invasiveSelective invasiveSelective invasiveTIMI IIIBTIMI IIIB86

29、/740 (11.6)86/740 (11.6)101/733 (13.8)101/733 (13.8)VANQWISHVANQWISH152/462 (32.9)152/462 (32.9)139/458 (30.3)139/458 (30.3)MATEMATE16/111 (14.4)16/111 (14.4)11/90 (12.2)11/90 (12.2)FRISC IIFRISC II127/1222 (10.4)127/1222 (10.4)174/1235 (14.1)174/1235 (14.1)TACTICSTACTICS81/1114 (7.3)81/1114 (7.3)10

30、5/1106 (9.5)105/1106 (9.5)VINOVINO4/64 (6.3)4/64 (6.3)15/67 (22.4)15/67 (22.4)RITARITA95/895 (10.6)95/895 (10.6)118/915 (12.9)118/915 (12.9)TotalTotal561/4608 (12.2)561/4608 (12.2)663/4604 (14.4)663/4604 (14.4)Odds Ratio (95% Cl)Favors RoutineInvasiveFavors SelectiveInvasiveOR, 0.820.72-0.93P0.0010.

31、11.010Meta-analysis of Conservative vs. Invasive Strategies in ACS9,212 randomized pts in 7 trials9,212 randomized pts in 7 trialsComposite death or MI from rand to latest FUComposite death or MI from rand to latest FU18%18%SourceSourceRoutine No./Total (%)Routine No./Total (%)Selective No./Total (%

32、)Selective No./Total (%)TIMI IIIBTIMI IIIB218/740 (29.5)218/740 (29.5)265/733 (36.2)265/733 (36.2)VANQWISHVANQWISH275/462 (59.5)275/462 (59.5)287/458 (62.7)287/458 (62.7)MATEMATE25/111 (22.5)25/111 (22.5)20/90 (22.2)20/90 (22.2)FRISC IIFRISC II451/1222 (36.9)451/1222 (36.9)704/1235 (57.0)704/1235 (5

33、7.0)TACTICSTACTICS123/1114 (11.0)123/1114 (11.0)152/1106 (13.7)152/1106 (13.7)VINOVINO16/64 (25.0)16/64 (25.0)25/67 (37.3)25/67 (37.3)RITARITA379/863 (43.9)379/863 (43.9)436/882 (49.4)436/882 (49.4) TotalTotal1487/4576 (32.5)1487/4576 (32.5)1669/4571 (41.3)1669/4571 (41.3)Meta-analysis of Conservati

34、ve vs. Invasive Strategies in ACSMehta SR et al. Mehta SR et al. JAMAJAMA 2005;293:2908-2917 2005;293:2908-2917SourceSourceRoutine No./Total (%)Routine No./Total (%)Selective No./Total (%)Selective No./Total (%)TIMI IIIBTIMI IIIB106/740 (14.3)106/740 (14.3)123/733 (16.8)123/733 (16.8)VANQWISHVANQWIS

35、H68/462 (14.7)68/462 (14.7)69/458 (15.1)69/458 (15.1)MATEMATE6/111 (5.4)6/111 (5.4)0/90 (0)0/90 (0)FRISC IIFRISC II32/1170 (2.7)32/1170 (2.7)81/1170 (6.9)81/1170 (6.9)TACTICSTACTICS80/1114 (7.2)80/1114 (7.2)73/1106 (6.6)73/1106 (6.6)VINOVINO9/64 (14.1)9/64 (14.1)12/67 (17.9)12/67 (17.9)RITARITA206/8

36、62 (23.9)206/862 (23.9)275/883 (31.1)275/883 (31.1)TotalTotal507/4525 (11.2)507/4525 (11.2)633/4507 (14.0)633/4507 (14.0)CCS Class III-IV AnginaRehospitalizationOdds Ratio (95% Cl)OR, 0.77 OR, 0.77 0.68-0.870.68-0.87P0.001P0.0010.11.0100.11.010OR, 0.66 0.60-0.72,P0.001Favors RoutineInvasiveFavors Se

37、lectiveInvasive23%23%34%34%Stable Coronary Artery DiseaseFibrotic plaqueCOURAGE: Study designBoden WE et al. Am Heart J. 2006;151:1173-9. Boden WE et al. N Engl J Med. 2007;356:1503-16.Optimal medical therapy* + PCI (n = 1149)Optimal medical therapy(n = 1138)AHA/ACC Class I/II indications for PCI, s

38、uitable coronary artery anatomy + 70% stenosis in 1 proximal epicardial vessel + objective evidence of ischemia (or 80% stenosis + CCS class III angina without provocation testing) Primary outcomes: All-cause mortality, nonfatal MIFollow-up: Median 4.6 yearsRandomized*Intensive pharmacologic therapy

39、 + lifestyle interventionCCS = Canadian Cardiovascular SocietySecondary outcomes: Death, MI, stroke; ACS hospitalizationNumber at RiskMedical Therapy 1138 1017 959 834 638 408 192 30PCI 1149 1013 952 833 637 417 200 35Years01234560.00.50.60.70.80.91.0PCI + OMTOptimal Medical Therapy (OMT)Hazard rati

40、o: 1.05Hazard ratio: 1.0595% CI (0.87-1.27)95% CI (0.87-1.27)P = 0.62P = 0.627Survival Free from Death and MI(median FU 4.6 yrs)Boden WE et al. Boden WE et al. NEJMNEJM 2007;356:1503-16 2007;356:1503-16Freedom fromDeath or MI (%)Death/MIat 4.6 yrs19.0%18.5%COURAGE: Treatment effect on primary outcom

41、eHR 1.05(0.87-1.27)P = 0.62*Boden WE et al. N Engl J Med. 2007;356:1503-16.All-cause death, MI (time to first event)*UnadjustedNo. at riskMedical therapy1138101795983463840819230PCI1149101395283363741720035Medical therapy PCI + medical therapySurvival free of primaryoutcome024700.50.60.70.81.00.9Yea

42、rs6531No. at riskMedical therapyPCI38443023124684887177339179291029105110731094113811491201341922004094186386378348339629541019101511381149COURAGE: Treatment effectsBoden WE et al. N Engl J Med. 2007;356:1503-16.*UnadjustedAll-cause deathMyocardial infarctionOverall survival Survival free of MIPCI +

43、 medical therapy1.00.90.70.8Medical therapy1.00.90.70.8012345670YearsYears012345670HR 0.87(0.65-1.16)P = 0.38*HR 1.13(0.89-1.43)P = 0.33*COURAGE: Treatment effect on hospitalization for ACSBoden WE et al. N Engl J Med. 2007;356:1503-16.*UnadjustedHR 1.07(0.84-1.37)P = 0.56*No. at riskMedical therapy

44、PCI1271342362464184316626678338359569571025102711381149Survival free of ACSYears0012345671.00.90.70.8PCI + medical therapyMedical therapyCOURAGE: Treatment effect on anginaBoden WE et al. N Engl J Med. 2007;356:1503-16.P 50%Previous CABGNoYes50%Baseline characteristicsHazard ratio (95% CI)PCI + OMT

45、compared to OMT resulted in:PCI + OMT compared to OMT resulted in: Significantly less use of nitrates at Significantly less use of nitrates at- 1 year (53% vs. 67%)- 1 year (53% vs. 67%)- 3 years (47% vs. 61%)- 3 years (47% vs. 61%)- 5 years (40% vs. 57%)- 5 years (40% vs. 57%) Significantly less us

46、e of Ca Significantly less use of Ca+2+2 channel blockers at channel blockers at- 1 year (40% vs. 49%)- 1 year (40% vs. 49%)- 3 years (43% vs. 50%)- 3 years (43% vs. 50%)- 5 years (42% vs. 52%)- 5 years (42% vs. 52%)Freedom from Anti-anginalanginal Meds Meds During Long-term Follow-upDuring Long-ter

47、m Follow-upDespite a much higher than anticipated XO to PCI in the OMT groupDespite a much higher than anticipated XO to PCI in the OMT groupBoden WE et al. Boden WE et al. NEJMNEJM 2007;356:1503-16 2007;356:1503-16Follow-upFollow-upPCI + OMTPCI + OMTOMTOMTP P Value ValueBaselineBaseline51 51 + + 25

48、 2551 51 + + 25 250.830.833 months3 months73 73 + + 22 2268 68 + + 23 230.000110%(n=62)Shaw LA. AHA 2007MPS % Ischemic MyocardiumPre-Rx & 6-18 Months0405101520253530Pre-Rx6-18m8.2%5.5%(4.7%-6.3%)PCI + OMT (n=159)PCI + OMT (n=159)OMT (n=155)OMT (n=155)0405101520253530Pre-Rx6-18m(6.9%-9.4%)8.6%8.1%Mea

49、n = -2.7% (95% CI = -3.8% to -1.7%)Mean = -0.5%(95% CI = -1.6% to 0.6%)p0.0001p0.0001Shaw LA. AHA 2007Ischemia reduction 5% with Ischemia Reduction 5% Myocardiump=0.007p=0.007PCI + OMT (n=54)PCI + OMT (n=54)OMT (n=51)OMT (n=51)In 105 pts with moderate-to-severe baseline ischemiaShaw LA. AHA 2007Deat

50、h or MI Rate (%)Rates of Death or MI by IschemiaReductionp=0.001p=0.001Ischemia Reduction 5%(n=68)No Ischemia Reduction(n=37)Shaw LA. AHA 2007In 105 pts with moderate-to-severe baseline ischemia 结论结论标准药物治疗对改善稳定性标准药物治疗对改善稳定性CADCAD预后有重要价值，所有预后有重要价值，所有CADCAD患者不论是否介入治疗都要标准药物治疗二级预防，患者不论是否介入治疗都要标准药物治疗二级预防，争取达标争取达标轻轻- -中度病变、无症状或轻微症状，药物治疗中度病变、无症状或轻微症状，药物治疗中度以上心绞痛中度以上心绞痛 标准药物治疗后心绞痛缓解不满意，标准药物治疗后心绞痛缓解不满意，介入治疗介入治疗稳定性稳定性CADCAD中中/ /重度缺血者，重度缺血者，PCIPCI可减少死亡、可减少死亡、MIMI病变弥漫或病变弥漫或 PCIPCI不能达到完全血管重建者不能达到完全血管重建者 应应CABGCABGThank you