經(jīng)皮冠狀動脈介入治療指南(2009)解讀課件

1、經(jīng)皮冠狀動脈介入治療指南(2009)解讀,推薦強(qiáng)度的類別以國際通用的方式表達(dá)如下,指南對適應(yīng)證的建議,證據(jù)的水平以國際通用的方式表達(dá)如下,指南對適應(yīng)證的建議,血管重建策略選擇,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 f

2、or 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 pharmacolog

3、ic therapy + lifestyle interventionCCS = 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,0,1,2,3,4,5,6,0.0,0.5,0.6,0.7,0.8,0.9,1.0,PCI + OMT,Optimal M

4、edical Therapy (OMT,Hazard ratio: 1.05 95% CI (0.87-1.27) P = 0.62,7,Survival Free from Death and MI(median FU 4.6 yrs,Boden WE et al. NEJM 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

5、0.001,P = 0.02,NS,Angina-free(,NS,Ischemia reduction 5, with Ischemia Reduction 5% Myocardium,p=0.007,PCI + OMT (n=54,OMT (n=51,In 105 pts with moderate-to-severe baseline ischemia,Shaw LA. AHA 2007,Death or MI Rate (,Rates of Death or MI by IschemiaReduction,p=0.001,Ischemia Reduction 5% (n=68,No I

6、schemia Reduction (n=37,Shaw LA. AHA 2007,In 105 pts with moderate-to-severe baseline ischemia,1.慢性穩(wěn)定性冠心?。?PCI是緩解慢性穩(wěn)定性冠心病患者癥狀的有效方法之一。 與藥物治療相比總體上不能降低死亡及MI發(fā)生率， 但有證據(jù)表明，在有較大范圍心肌缺血的患者中PCI仍比藥物治療具有優(yōu)勢。 PCI應(yīng)主要用于有效藥物治療的基礎(chǔ)上仍有癥狀的患者以及有明確較大范圍心肌缺血證據(jù)的患者,慢性穩(wěn)定性冠心病PCI推薦指征,Intended all-comers study design instead of a

7、highly selected patient population Consensus physician agreement (surgeon 1:219-227 Valgimigli et al, Am J Cardiol 2007;99:1072-1081 Serruys et al, EuroIntervention 2007;3:450-459,BARI classification of coronary segments Leaman score, Circ 1981;63:285-299 Lesions classification ACC/AHA , Circ 2001;1

8、03:3019-3041 Bifurcation classification, CCI 2000;49:274-283 CTO classification, J Am Coll Cardiol 1997;30:649-656,Dominance,P=0.19,7.7,13.0,Event rate 1.5 SE, *Fisher exact test,Calculated by core laboratory; ITT population,MACCE to 12 Months by SYNTAX Score TertileLow Scores (0-22) LM Subset,Event

9、 rate 1.5 SE, *Fisher exact test,Calculated by core laboratory; ITT population,P=0.54,15.5,12.6,MACCE to 12 Months by SYNTAX Score TertileIntermediate Scores (23-32) LM Subset,P=0.008,25.3,12.9,Event rate 1.5 SE, *Fisher exact test,Calculated by core laboratory; ITT population,MACCE to 12 Months by

10、SYNTAX Score TertileHigh Scores (33) Left Main Subset,Overall MACCE at 12 MonthsLeft Main Subset,ITT population,n=705,n=91,n=138,n=218,n=258,P=0.44,P=1.0,P=0.27,P=0.29,P=0.42,Patients (,n=705,n=91,n=138,n=218,n=258,Patients (,Safety at 12 MonthsDeath/CVA/MI in the Left Main Subset,P=0.29,P=1.0,P=0.7

11、2,P=0.57,P=0.11,MACCE to 12 Months 3VD Subset,P0.001,19.1,11.2,ITT population,Event Rate 1.5 SE, *Fisher exact test,CABG,TAXUS,P=0.39,3 Vessel Disease,n=34,n=43,per protocol and ITT populations had same outcome,Combined Safety (Death/CVA/MI) 3VD,Patients (,MACCE to 12 Months vs SYNTAX Score,SYNTAX S

12、core 22,P=0.10,P0.001,P=0.71,12-month MACCE, ,SYNTAX Score,KM Estimates, Event Rate 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only,RCT ITT pts; site-reported data,SYNTAX Score 23-32,SYNTAX Score 33,Patient 1,Patient 1,Patient 2,Patient 2,LCx 70-90,RCA3 70-90,LCx 100,LAD 99

13、,RCA 100,There is 3-vessel disease and 3-vessel disease,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 Selective Invasive,OR, 0.82 0.72-0

14、.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-IV Angina,Rehospitalization,Odds

15、 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,23,34,2.非ST段抬高ACS：包括不穩(wěn)定性心絞痛和非ST段抬高M(jìn)I 采取早期保守策略和早期介入策略 循證醫(yī)學(xué)證據(jù)表明：對危險度高的患者，早期介入治療策略顯示了明顯優(yōu)勢 PCI的指征是建立在危險分層的基礎(chǔ)上。 對于低危和早期未行PCI的非ST段抬高ACS患者出院前應(yīng)進(jìn)行必要的評估，根據(jù)心功能、心肌缺血情況和再發(fā)心血

16、管事件的危險采取相應(yīng)的治療,非ST段抬高ACS患者PCI指征推薦,AMI: Pathophysiology,Ruptured plaque with occlusive thrombus,23 Randomized Trials of PCI vs. Lysis,P0.0001,N = 7,739,Keeley, Grines. Lancet 2003;361:13-20,P0.0001,p=0.0002,p=0.0002,Mortality in Subgroups in SHOCK Study,Revasc Medical Difference RR（95%CI） P 30d Mortal

17、ity (152) 46.7 56.0 -9.3 0.83(0.07-1.04) 0.11 75yrs(24) 79.2 56.0 +22.9 1.41(0.97-2.03) 0.003,3.急性STEMI： 循證醫(yī)學(xué)證據(jù)表明，PCI能有效降低STEMI總體死亡率。 總體死亡率降低的獲益仍取決于以下因素的影響： 患者發(fā)病時間 梗死部位及心功能狀況所構(gòu)成的總體危險度 患者年齡及合并疾病情況 醫(yī)生經(jīng)驗及導(dǎo)管室人員熟練配合程度 進(jìn)門-球囊擴(kuò)張（door-to-balloon ，D-to-B）時間,STEMI患者直接PCI推薦指征,STEMI補(bǔ)救PCI的推薦指征,早期溶栓成功或未行溶栓患者擇期PCI的

18、推薦指征,PCI方法的選擇,DES vs BMS,From TCT 2006,DES - the good, the bad, and the ugly,40 mos,BMS,DES,Incomplete apposition,Late stent thrombosis,Abn Vasomotion,P0.001 vs. control,Sirolimus Control,Delayed Healing,Angioscopy,BMS,DES,Late loss = 0,Eos,Giant cells,IVUS,Inflammation,All-Cause Mortality: All RCTs

19、,8,867 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: RCTs (On-Label,4,818 patients, 10 trials,Favors DES,Favors BMS,Est

20、imate (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: RCTs (Off-Label,4,049 patients, 12 trials,Favors DES,Favors BMS,Estimate (95% CI,Weight (,0.84 (0.62,1.13) 0.84 (0.62,

21、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 Registries,169,595 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 Eff

22、ects,Mean f/u 2.5 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: Adjusted Registries,136,558 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

23、Gregg W. Stone, 2008,Where Do We Go From Here,DES和BMS推薦選擇指征（1,DES和BMS推薦選擇指征（2,Harmonizing Outcomes with Revascularization and Stents in AMI,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) Biv

24、alirudin (n=1800,3602 pts with STEMI,93.1% of all stented pts were randomized,2257,2132,2098,2069,1868,749,697,675,658,603,Number at risk,TAXUS DES,EXPRESS BMS,Primary Efficacy Endpoint: Ischemic TLR,Ischemic TLR (,0,1,2,3,4,5,6,7,8,9,10,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,7.5,4.5,Diff 95%CI

25、 = -3.0% -5.1, -0.9 HR 95%CI = 0.59 0.43, 0.83 P=0.002,TAXUS DES (n=2257,EXPRESS BMS (n=749,Ischemic TVR (,0,1,2,3,4,5,6,7,8,9,10,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,2119,2078,2045,1848,749,695,669,650,598,Number at risk,TAXUS DES,EXPRESS BMS,8.7,5.8,Diff 95%CI = -3.0% -5.2, -0.7 HR 95%

26、CI = 0.65 0.48, 0.89 P=0.006,TAXUS DES (n=2257,EXPRESS BMS (n=749,Secondary Efficacy Endpoint: Ischemic TVR,Primary Safety Endpoint: Safety MACE,Safety MACE (,0,1,2,3,4,5,6,7,8,9,10,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,2115,2086,2057,1856,749,697,683,672,619,Number at risk,TAXUS DES,EXPR

27、ESS BMS,TAXUS DES (n=2257,EXPRESS BMS (n=749,8.1,8.0,Diff 95%CI = 0.1% -2.1, 2.4 HR 95%CI = 1.02 0.76, 1.36 PNI=0.01 PSup=0.92,Safety MACE = death, reinfarction, stroke, or stent thrombosis,One-Year All-Cause Mortality,Mortality (,0,1,2,3,4,5,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,2180,2161,2147,1949,749,716,712,702,648,Number at risk,TAXUS DES,EXPRESS BMS,TAXUS DES (n=2257,EXPRESS BMS (n=749,3.5,3.5,HR 95%CI = 0.99 0.64,1.55 P=0.98,One-Year Death or Reinfarction,Stent Thrombosis (ARC Definite or Probable,D