经皮冠状动脉介入治疗指南（2009）解读

经皮冠状动脉介入治疗指南(2009) 解读 中国医学科学院阜外心血管病医院 高润霖 推荐强度的类别以国际通用的方式表达如下： 类类 已证实证实 和（或）一致公认认某诊疗诊疗 措施有益、有用和 有效 类类 某诊疗诊疗 措施的有用性和有效性的证证据尚有矛盾或存在 不同观观点 a类类有关证证据和（或）观观点倾倾向于有用和有效。 b类类有关证证据和（或）观观点尚不能充分说说明有用和有效。 类类* 已证实证实 和（或）一致公认认某诊疗诊疗 措施无用和无效并 在有些病例可能有害，不推荐应应用。 指南对适应证的建议 证据的水平以国际通用的方式表达如下 证据水平 A资料来自于多项随机临床试验或汇总分析 证据水平 B资料来自单项随机临床试验或多项非随机试验 证据水平 C专家的意见和/或小型试验结果 指南对适应证的建议 血管重建策略选择 COURAGE Study Boden 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, suitable 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 MI Follow-up: Median 4.6 years Randomized *Intensive pharmacologic therapy + lifestyle intervention CCS = Canadian Cardiovascular Society Secondary outcomes: Death, MI, stroke; ACS hospitalization Number at Risk Medical Therapy 1138 1017 959 834 638 408 192 30 PCI 1149 1013 952 833 637 417 200 35 Years 0123456 0.0 0.5 0.6 0.7 0.8 0.9 1.0 PCI + OMT Optimal Medical Therapy (OMT) Hazard ratio: 1.05Hazard ratio: 1.05 95% CI (0.87-1.27)95% CI (0.87-1.27) P = 0.62P = 0.62 7 Survival Free from Death and MI (median FU 4.6 yrs) BodenBoden WE et al. WE et al. NEJMNEJM 2007;356:1503-16 2007;356:1503-16 Freedom from Death or MI (%) Death/MI at 4.6 yrs 19.0% 18.5% COURAGE: Treatment effect on angina Boden WE et al. N Engl J Med. 2007;356:1503-16. P 75yrs(24) 79.2 56.0 +22.9 1.41(0.97-2.03) 0.003 3.急性STEMI： n循证医学证据表明，PCI能有效降低STEMI总体死 亡率。 n总体死亡率降低的获益仍取决于以下因素的影响 ： 患者发病时间 梗死部位及心功能状况所构成的总体危险度 患者年龄及合并疾病情况 医生经验及导管室人员熟练配合程度 进门-球囊扩张（door-to-balloon ，D-to-B）时间 STEMI患者直接PCI推荐指征 指征 推荐 类别类别 证证据 水平 证证据来源 所有STEMI发发病12 h内，D to B时间时间 90 min以内，能 由有经验经验 的者和团队团队 操作者 IA PAMI,GUSTO IIb,PRAGUE- 1,PRAGUE- 2,DANAMI-2 溶栓禁忌证证患者 IC 发发病3 h的患者更趋趋首选选PCI IC 心原性休克，年龄龄75岁岁心原性休克，MI发发病75岁岁心原性休克，MI发发病36 h，休克 18 h，权权衡利弊后可考虑补虑补 救PCI a B Dauerman 血液动动力学或心电电不稳稳定 a C 早期溶栓成功或未行溶栓患者择期 PCI的推荐指征 指征 推荐 类别类别 证证 据水 平 证证据来源 病变变适宜PCI且有再发发MI的表现现 IC 病变变适宜PCI且有自发发或诱发诱发 缺血表现现 IB DANAMI 病变变适宜PCI且有心原性休克或血液动动力学 不稳稳定 IB SHOCK LVEF40%，心力衰竭，严严重室性心律失常 ，常规规行PCI a C 对对无自发发或诱发诱发 缺血的IRA的严严重狭窄于发发 病24 h后行PCI b C IRA完全闭闭塞，无症状的12支血管病变变， 无严严重缺血表现现，血液动动力学和心电电学稳稳定 ，不推荐发发病24 h后常规规行PCI A DECOPI,OAT, TOSCA2 PCI方法的选择 DES vs BMS From TCT 2006 DES - the good, the bad, and the ugly! 48 months48 months 40 40 mosmos BMSDES IncompleteIncomplete appositionapposition Late stent thrombosis AbnAbn VasomotionVasomotion *P0.001*P0.001 vs. control vs. control Sirolimus Sirolimus Control Control * * * * Delayed Healing!Delayed Healing! AngioscopyAngioscopy BMS DES Late loss = 0 Eos Giant cells IVUSIVUS InflammationInflammation All-Cause Mortality: All RCTs 8,867 patients, 21 trials8,867 patients, 21 trials Favors BMS Estimate (95% CI) Weight (%) 0.97 (0.81,1.15) 0.97 (0.81,1.15), p=0.72 Random Effects *Fixed Effects (I2=0.0%) Favors DES Mean f/u 2.9 yrs Ajay J. Kirtane and Gregg W. Stone, 2008 All-Cause Mortality: All-Cause Mortality: RCTsRCTs (On-Label) (On-Label) 4,818 patients, 10 trials4,818 patients, 10 trials Favors DESFavors BMS Estimate (95% CI) Weight (%) 1.05 (0.84,1.30) 1.05 (0.84,1.30), p=0.69 Random Effects *Fixed Effects (I2=0.0%) Mean f/u 4.0 yrs Ajay J. Kirtane and Gregg W. Stone, 2008 All-Cause Mortality: All-Cause Mortality: RCTsRCTs (Off-Label) (Off-Label) 4,049 patients, 12 trials4,049 patients, 12 trials Favors DESFavors BMS Estimate (95% CI) Weight (%) 0.84 (0.62,1.13) 0.84 (0.62,1.13), p=0.24 Random Effects *Fixed Effects (I2=0.0%) Mean f/u 1.5 yrs Ajay J. Kirtane and Gregg W. Stone, 2008 All-Cause Mortality: All RegistriesAll-Cause Mortality: All Registries 169,595 patients, 31 registries169,595 patients, 31 registries Favors BMS Estimate (95% CI) Weight (%) 0.78 (0.71,0.86), p0.001 0.81 (0.78,0.85) Favors DES *Random Effects (I2=71%) Fixed Effects Mean f/u 2.5 yrs Ajay J. Kirtane and Gregg W. Stone, 2008 All-Cause Mortality: Adjusted RegistriesAll-Cause Mortality: Adjusted Registries 136,558 patients, 19 registries136,558 patients, 19 registries Favors BMS Estimate (95% CI)Weight (%) 0.79 (0.71,0.89), p0.001 0.82 (0.79,0.86) Favors DES *Random Effects (I2=76%) Fixed Effects Mean f/u 2.7 yrs Ajay J. Kirtane and Gregg W. Stone, 2008 2006-2007DES Under Attack 2007-2008 Critical Reappraisal / Emerging Data 2008-? Lets Resume Moving Forward! Where Do We Go From Here? DES和BMS推荐选择指征（1） 指征 推荐 类别类别 证证据 水平 证证据来源 DES应应用于临临床试验证实试验证实 的DES有效性优优 于BMS的亚组亚组 (病情稳稳定的原位病变变，参考 血管直径2.254.00 mm，病变长变长 度30 mm)患者 IA RAVEL,SIRUS,E- SIRUS,C-SIRUS， TAXUS-II, TAXUS-IV ，TAXUS-VI 术术前，医生应应充分告知患者DES后须须双重 抗血小板治疗疗的时间时间 ，在肯定患者对该对该 治 疗疗的依从性后应应用DES ICGrines 对对近期须须要进进行侵入性操作和外科手术术， 12个月内必须间须间 断双重抗血小板治疗疗的患 者，应应置入BMS或单纯单纯 PTCA（必要时时置 入BMS） IC 慢性完全闭闭塞病变选变选 用DES IB PACTO,PRISON II DES和BMS推荐选择指征（2） 指征 推荐 类别类别 证证据 水平 证证据来源 BMS置入后再狭窄病变选变选 用DES a B ISAR-DESIRE, SISR,RIBS-2 分叉病变变的主支血管置入DES、侧侧支球囊 扩张扩张 a B SCANDSTENT 有选择选择 的无保护护左主干病变选变选 用DES a B Chieffo,SYNTAX 长长病变变（病变长变长 度30 mm）选选用DES a B Dawkins,TAXUS- V 急性心肌梗死选选用DES a B TYPHOON,SESA MI,HORIZONS AMI,Garg TAXUS DES N=2257 EXPRESS BMS N=749 RandomizedRandomized 1 year FU1 year FU N=2186 (96.9%) N=715 (95.5%) Withdrew Withdrew Lost to FU Lost to FU 1818 5353 7 7 2727 R 3:1 Harmonizing Outcomes with Revascularization and Stents in AMI 3006 pts eligible for stent rand.3006 pts eligible for stent rand. Primary Medical Rx193 Primary CABG 62 Deferred PCI 2 Index PCI, not eligible - PTCA only119 - Stented220 UFH + GPI (n=1802) Bivalirudin (n=1800) R 1:13602 pts with STEMI3602 pts with STEMI 93.1% of all stented pts were randomized 2257225721322132209820982069206918681868 749749697697675675658658603603 Number at riskNumber at risk TAXUS DESTAXUS DES EXPRESS BMSEXPRESS BMS Primary Efficacy Endpoint: Primary Efficacy Endpoint: Ischemic TLRIschemic TLR Ischemic TLR (%)Ischemic TLR (%) 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 1010 Time in MonthsTime in Months 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 101011111212 7.5%7.5% 4.5%4.5% Diff 95%CI =Diff 95%CI = -3.0% -5.1, -0.9-3.0% -5.1, -0.9 HR 95%CI =HR 95%CI = 0.59 0.43, 0.830.59 0.43, 0.83 P=0.002P=0.002 TAXUS DES (n=2257)TAXUS DES (n=2257) EXPRESS BMS (n=749)EXPRESS BMS (n=749) Ischemic TVR (%) 0 1 2 3 4 5 6 7 8 9 10 Time in Months 0123456789101112 2257225721192119207820782045204518481848 749749695695669669650650598598 Number at riskNumber at risk TAXUS DESTAXUS DES EXPRESS BMSEXPRESS BMS 8.7% 5.8% Diff 95%CI = -3.0% -5.2, -0.7 HR 95%CI = 0.65 0.48, 0.89 P=0.006 TAXUS DES (n=2257)TAXUS DES (n=2257) EXPRESS BMS (n=749)EXPRESS BMS (n=749) Secondary Efficacy Endpoint: Secondary Efficacy Endpoint: Ischemic TVRIschemic TVR Primary Safety Endpoint: Primary Safety Endpoint: Safety MACE*Safety MACE* Safety MACE (%)Safety MACE (%) 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 1010 Time in MonthsTime in Months 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 101011111212 2257225721152115208620862057205718561856 749749697697683683672672619619 Number at riskNumber at risk TAXUS DESTAXUS DES EXPRESS BMSEXPRESS BMS TAXUS DES (n=2257)TAXUS DES (n=2257) EXPRESS BMS (n=749)EXPRESS BMS (n=749) 8.1%8.1% 8.0%8.0% Diff 95%CI =Diff 95%CI = 0.1% -2.1, 2.40.1% -2.1, 2.4 HR 95%CI =HR 95%CI = 1.02 0.76, 1.361.02 0.76, 1.36 P P NINI=0.01 =0.01 P P SupSup=0.92 =0.92 * * Safety MACE = death, reinfarction, stroke, or stent thrombosisSafety MACE = death, reinfarction, stroke, or stent thrombosis One-Year All-Cause MortalityOne-Year All-Cause Mortality Mortality (%) 0 1 2 3 4 5 Time in Months 0123456789101112 2257225721802180216121612147214719491949 749749716716712712702702648648 Number at riskNumber at risk TAXUS DESTAXUS DES EXPRESS BMSEXPRESS BMS TAXUS DES (n=2257)TAXUS DES (n=2257) EXPRESS BMS (n=749)EXPRESS BMS (n=749) 3.5% 3.5% HR 95%CI = 0.99 0.64,1.55 P=0.98 One-Year Death or ReinfarctionOne-Year Death or Reinfarction Death or MI (%) 0 1 2 3 4 5 6 7 8 Time in Months 0123456789101112 2257225721402140211021102083208318821882 749749703703689689678678625625 Number at riskNumber at risk TAXUS DESTAXUS DES EXPRESS BMSEXPRESS BMS TAXUS DES (n=2257)TAXUS DES (n=2257) EXPRESS BMS (n=749)EXPRESS BMS (n=749) 7.0% 6.8% HR 95%CI = 0.97 0.70,1.32 P=0.83 Stent Thrombosis (ARC Definite or Probable) 2238223821222122209820982078207818841884 744744701701694694683683629629 Number at riskNumber at risk TAXUS DESTAXUS DES EXPRESS BMSEXPRESS BMS Stent Thrombosis (%)Stent Thrombosis (%) 0 0 1 1 2 2 3 3 4 4 Time in MonthsTime in Months 0 0 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 101011111212 TAXUS DES (n=2238)TAXUS DES (n=2238) EXPRESS BMS (n=744)EXPRESS BMS (n=744) 3.4% 3.1% HR 95%CI = 0.92 0.58,1.45 P=0.72 DES和BMS推荐选择指征（3） 指征 推荐 类类 别别 证证据 水平 证证据来源 下述病变选变选 用DES的疗疗效或安全性尚待确定 ： 分叉病变计变计 划双支架置入 多支病变变合并糖尿病 DES后再狭窄 旁路移植血管病变变 b II b II b II b B B C B NORDIC SYNTAX OKABE 任何