經(jīng)皮冠狀動脈介入治療指南解讀

1、經(jīng)皮冠狀動脈介入治療指南經(jīng)皮冠狀動脈介入治療指南(2009)解讀解讀中國醫(yī)學(xué)科學(xué)院阜外心血管病醫(yī)院中國醫(yī)學(xué)科學(xué)院阜外心血管病醫(yī)院 高潤霖高潤霖類類已證實和（或）一致公認某診療措施有益、有用和有已證實和（或）一致公認某診療措施有益、有用和有效效類類某診療措施的有用性和有效性的證據(jù)尚有矛盾或存在某診療措施的有用性和有效性的證據(jù)尚有矛盾或存在不同觀點不同觀點 aa類類有關(guān)證據(jù)和（或）觀點傾向于有用和有效。有關(guān)證據(jù)和（或）觀點傾向于有用和有效。 bb類類有關(guān)證據(jù)和（或）觀點尚不能充分說明有用和有效。有關(guān)證據(jù)和（或）觀點尚不能充分說明有用和有效。類類* *已證實和（或）一致公認某診療措施無用和無效并在已

2、證實和（或）一致公認某診療措施無用和無效并在有些病例可能有害，不推薦應(yīng)用。有些病例可能有害，不推薦應(yīng)用。指南對適應(yīng)證的建議指南對適應(yīng)證的建議證據(jù)水平證據(jù)水平 a資料來自于多項隨機臨床試驗或匯總分析資料來自于多項隨機臨床試驗或匯總分析證據(jù)水平證據(jù)水平 b資料來自單項隨機臨床試驗或多項非隨機試驗資料來自單項隨機臨床試驗或多項非隨機試驗證據(jù)水平證據(jù)水平 c專家的意見和專家的意見和/或小型試驗結(jié)果或小型試驗結(jié)果指南對適應(yīng)證的建議指南對適應(yīng)證的建議boden we et al. am heart j. 2006;151:1173-9. boden we et al. n engl j med. 2007

3、;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

4、testing) primary outcomes: all-cause mortality, nonfatal mifollow-up: median 4.6 yearsrandomized*intensive pharmacologic therapy + lifestyle interventionccs = canadian cardiovascular societysecondary outcomes: death, mi, stroke; acs hospitalizationnumber at riskmedical therapy 1138 1017 959 834 638

5、408 192 30pci 1149 1013 952 833 637 417 200 35years01234560.00.50.60.70.80.91.0pci + omtoptimal medical therapy (omt)7freedom fromdeath or mi (%)death/miat 4.6 yrs19.0%18.5%boden we et al. n engl j med. 2007;356:1503-16.p 0.001p = 0.02nsangina-free(%)nsischemia reduction 5%in 105 pts with moderate-t

6、o-severe baseline ischemiashaw la. aha 2007death or mi rate (%)ischemia reduction 5%(n=68)no ischemia reduction(n=37)shaw la. aha 2007in 105 pts with moderate-to-severe baseline ischemia intended all-comers study design instead of a highly selected patient population consensus physician agreement (s

7、urgeon & cardiologist) instead of inclusion & exclusion criteria and, nested registries for cabg only and pci only to define patient characteristics and outcomes of these two unique treatment options71% enrolled (n=3,075)all pts with de novo 3vd and/or lm disease (n=4,337) treatment preferen

8、ce (9.4%) referring md or pts. refused informed consent (7.0%) inclusion/exclusion (4.7%) withdrew before consent (4.3%) other (1.8%) medical treatment (1.2%)taxusn=903pcin=198cabgn=1077cabgn=897no f/un=4285yr f/un=649pciall captured w/ follow upcabg2500750 w/ f/utotal enrollment n=3075stratificatio

9、n: lm and diabetestwo registry armsrandomized armsn=1800two registry armsn=1275randomized armsn=1800heart team (surgeon & interventionalist)pcin=198cabgn=1077amenable for only one treatment approachtaxus*n=903 cabgn=897amenable for bothtreatment optionsstratification: lm and diabeteslm33.7%3vd66

10、.3%lm34.6%3vd65.4%23 us sites62 eu sites+ +itt populationevent rate 1.5 se, *fisher exact testall deathrevascularizationcva (stroke)myocardial infarctiontaxus* (n=903)cabg (n=897)p=0.0015*061210200months since allocationcumulative event rate (%)itt population12.1% 17.8% event rate 1.5 se. *fishers e

11、xact testtaxus* (n=903)cabg (n=897)p=0.89patients (%)itt populationtaxus* (n=903)cabg (n=897)p=0.44*061220400months since allocationcumulative event rate (%)13.6% 15.8% taxus (n=357)cabg (n=348)event rate 1.5 se, *fisher exact testitt populationsianos et al, eurointervention 2005;1:219-227valgimigli

12、 et al, am j cardiol 2007;99:1072-1081serruys et al, eurointervention 2007;3:450-459bari classification of coronary segmentsleaman score, circ 1981;63:285-299lesions classification acc/aha , circ 2001;103:3019-3041bifurcation classification, cci 2000;49:274-283cto classification, j am coll cardiol 1

13、997;30:649-656061220400months since allocationcumulative event rate (%)taxus (n=118)cabg (n=103)p=0.19*7.7%13.0%event rate 1.5 se, *fisher exact testcalculated by core laboratory; itt populationmean baselinesyntax scorecabg15.5 4.3taxus 15.7 4.4061220400months since allocationcumulative event rate (

14、%)taxus (n=195)cabg (n=92)event rate 1.5 se, *fisher exact testcalculated by core laboratory; itt populationp=0.54*15.5%12.6%macce to 12 months by syntax score tertileintermediate scores (23-32) lm subset mean baselinesyntax scorecabg27.2 3.0taxus 27.0 2.7061220400months since allocationcumulative e

15、vent rate (%)taxus (n=135)cabg (n=150)p=0.008*25.3%12.9%event rate 1.5 se, *fisher exact testcalculated by core laboratory; itt populationmacce to 12 months by syntax score tertilehigh scores (33) left main subsetmean baselinesyntax scorecabg42.1 7.6taxus 43.8 9.1itt populationtaxus*cabg(n=705)(n=91

16、)(n=138)(n=218)(n=258)p=0.44p=1.0p=0.27p=0.29p=0.42patients (%)taxus*cabg(n=705)(n=91)(n=138)(n=218)(n=258)patients (%)p=0.29p=1.0p=0.72p=0.57p=0.11061220400months since allocationcumulative event rate (%)p0.001*19.1%11.2%itt populationevent rate 1.5 se, *fisher exact testtaxus (n=546)cabg (n=549)ca

17、bgtaxus*p=0.393 vessel disease*n=34n=43*per protocol and itt populations had same outcomepatients (%)syntax score2212-month macce, %syntax scorekm estimates, event rate 1.5 se; *chi square test; raw syntax score for illustrative purposes onlyrct itt pts; site-reported datasyntax score23-32syntax sco

18、re33taxus* (n=903)cabg (n=897)composite of death or myocardial infarctionno./total (%)odds ratio (95% cl)favors routineinvasivefavors selectiveinvasiveor, 0.820.72-0.93p0.0010.11.010ccs class iii-iv anginarehospitalizationodds ratio (95% cl)0.11.0100.11.010or, 0.66 0.60-0.72,p0.001favors routineinva

19、sivefavors selectiveinvasivep=0.0002from tct 2006des - the good, the bad, and the ugly!bmsdeslate stentthrombosisbmsdeslate loss = 0eosgiant cellsi-v overall (i-squared = 0.0%, p = 0.918)basket (ses only)taxus iihaamu-stentsevilleortolani et altaxus ive-siriusstudy iddiabetesprison iistrategyravelse

20、s-smarttaxus vtyphoonmission!scorpiussesamid+l overallpassionc-siriuspache et alsirius0.97 (0.81, 1.15)0.82 (0.37, 1.84)1.61 (0.57, 4.53)2.00 (0.63, 6.38)1.35 (0.23, 7.78)2.00 (0.19, 21.38)0.89 (0.63, 1.25)1.08 (0.25, 2.24)es (95% ci)1.44 (0.48, 4.33)0.50 (0.09, 2.67)0.84 (0.36, 1.96)1.75 (0.73, 4.1

21、6)0.21 (0.02, 1.71)0.97 (0.57, 1.65)1.01 (0.38, 2.65)0.48 (0.09, 2.59)1.28 (0.35, 4.61)0.43 (0.11, 1.63)0.97 (0.81, 1.15)0.70 (0.36, 1.36)0.68 (0.11, 4.04)1.40 (0.45, 4.35)1.02 (0.67, 1.54)100.004.802.872.301.000.5526.292.57(i-v)2.551.074.304.080.6210.923.271.09weight1.861.706.990.952.4017.82%0.97 (

22、0.81, 1.15)0.82 (0.37, 1.84)1.61 (0.57, 4.53)2.00 (0.63, 6.38)1.35 (0.23, 7.78)2.00 (0.19, 21.38)0.89 (0.63, 1.25)1.08 (0.25, 2.24)es (95% ci)1.44 (0.48, 4.33)0.50 (0.09, 2.67)0.84 (0.36, 1.96)1.75 (0.73, 4.16)0.21 (0.02, 1.71)0.97 (0.57, 1.65)1.01 (0.38, 2.65)0.48 (0.09, 2.59)1.28 (0.35, 4.61)0.43

23、(0.11, 1.63)0.97 (0.81, 1.15)0.70 (0.36, 1.36)0.68 (0.11, 4.04)1.40 (0.45, 4.35)1.02 (0.67, 1.54)100.004.802.872.301.000.5526.292.57(i-v)2.551.074.304.080.6210.923.271.09weight1.861.706.990.952.4017.82% 1.1110favors bmsestimate (95% ci) weight (%)0.97 (0.81,1.15)0.97 (0.81,1.15), p=0.72random effect

24、s*fixed effects (i2=0.0%)favors desmean f/u 2.9 yrsajay j. kirtane and gregg w. stone, 2008i-v overall (i-squared = 0.0%, p = 0.927)ortolani et altaxus v - simpled+l overalltaxus ivpache et alc-siriuse-siriussiriustaxus iistudy idravelscorpius1.05 (0.84, 1.30)2.00 (0.19, 21.38)1.09 (0.53, 2.22)1.05

25、(0.84, 1.30)0.89 (0.63, 1.25)1.40 (0.45, 4.35)0.68 (0.11, 4.04)1.08 (0.25, 2.24)1.02 (0.67, 1.54)1.61 (0.57, 4.53)es (95% ci)1.75 (0.73, 4.16)1.28 (0.35, 4.61)100.000.859.2040.203.67%1.453.9327.254.39(i-v)6.232.84weight 1.1110favors desfavors bmsestimate (95% ci) weight (%)1.05 (0.84,1.30)1.05 (0.84

26、,1.30), p=0.69random effects*fixed effects (i2=0.0%)mean f/u 4.0 yrsajay j. kirtane and gregg w. stone, 2008i-v overall (i-squared = 0.0%, p = 0.798)haamu-stentpassionprison iimission!diabetesbasket (ses only)sevilled+l overallses-smartstrategytaxus v - complexstudy idsesamityphoon0.84 (0.62, 1.13)2

27、.00 (0.63, 6.38)0.70 (0.36, 1.36)0.50 (0.09, 2.67)0.48 (0.09, 2.59)1.44 (0.48, 4.33)0.82 (0.37, 1.84)1.35 (0.23, 7.78)0.84 (0.62, 1.13)0.21 (0.02, 1.71)0.84 (0.36, 1.96)0.84 (0.38, 1.84)es (95% ci)0.43 (0.11, 1.63)1.01 (0.38, 2.65)100.006.6420.16weight3.103.167.3613.84%2.871.8012.4014.32(i-v)4.909.4

28、4 1.1110favors desfavors bmsestimate (95% ci) weight (%)0.84 (0.62,1.13)0.84 (0.62,1.13), p=0.24random effects*fixed effects (i2=0.0%)mean f/u 1.5 yrsajay j. kirtane and gregg w. stone, 2008note: weights are from random effects analysisd+l overall (i-squared = 70.9%, p = 0.000)asan korea (adjusted)s

29、martmelbournemassachusetts (matched)washington hosp center (matched)multicenter svg (adjusted)i-v overallrotterdam off-labelstent (adjusted)acuity (from rct)real (adjusted)liverpool (matched)wake forest (adjusted)mayo ffr substudycedars acute mighost (adjusted)sussex elderlyeraci iii (from rct)ny st

30、ate (adjusted, unmatched)ontario (matched)study idmidas (adjusted)restemmcmaster stemi (adjusted)germany metabolic syndromewestern denmark (adjusted)arts ii (from rct)descover (unadjusted)northern new england (adjusted)scaar (adjusted)italian diabetic multivessel (adjusted)nhlbi (off label, adjusted

31、)nhlbi (on label, adjusted)0.78 (0.71, 0.86)0.60 (0.46, 0.79)0.59 (0.48, 0.71)0.67 (0.23, 1.94)0.79 (0.71, 0.89)1.16 (0.78, 1.75)1.33 (0.47, 3.76)0.81 (0.78, 0.85)0.98 (0.85, 1.13)0.69 (0.55, 0.87)0.63 (0.49, 0.82)0.83 (0.70, 0.98)0.45 (0.24, 0.84)0.72 (0.55, 0.95)1.00 (0.21, 4.75)0.82 (0.37, 1.83)0

32、.55 (0.36, 0.83)0.72 (0.30, 1.72)1.18 (0.54, 2.58)0.84 (0.72, 0.97)0.71 (0.59, 0.84)es (95% ci)0.66 (0.59, 0.74)0.73 (0.51, 1.05)0.17 (0.03, 0.97)1.47 (0.65, 3.35)1.00 (0.86, 1.17)0.74 (0.41, 1.35)0.53 (0.35, 0.80)0.51 (0.26, 1.00)1.03 (0.94, 1.14)1.22 (0.36, 4.10)0.94 (0.64, 1.38)1.47 (0.87, 2.48)1

33、00.00weight4.355.230.716.153.020.745.854.834.505.551.70%4.310.351.162.911.001.205.775.46(d+l)6.143.400.281.115.721.832.951.536.300.563.192.200.78 (0.71, 0.86)0.60 (0.46, 0.79)0.59 (0.48, 0.71)0.67 (0.23, 1.94)0.79 (0.71, 0.89)1.16 (0.78, 1.75)1.33 (0.47, 3.76)0.81 (0.78, 0.85)0.98 (0.85, 1.13)0.69 (

34、0.55, 0.87)0.63 (0.49, 0.82)0.83 (0.70, 0.98)0.45 (0.24, 0.84)0.72 (0.55, 0.95)1.00 (0.21, 4.75)0.82 (0.37, 1.83)0.55 (0.36, 0.83)0.72 (0.30, 1.72)1.18 (0.54, 2.58)0.84 (0.72, 0.97)0.71 (0.59, 0.84)es (95% ci)0.66 (0.59, 0.74)0.73 (0.51, 1.05)0.17 (0.03, 0.97)1.47 (0.65, 3.35)1.00 (0.86, 1.17)0.74 (

35、0.41, 1.35)0.53 (0.35, 0.80)0.51 (0.26, 1.00)1.03 (0.94, 1.14)1.22 (0.36, 4.10)0.94 (0.64, 1.38)1.47 (0.87, 2.48)100.00weight4.355.230.716.153.020.745.854.834.505.551.70%4.310.351.162.911.001.205.775.46(d+l)6.143.400.281.115.721.832.951.536.300.563.192.20 1.1110favors bmsestimate (95% ci) weight (%)

36、0.78 (0.71,0.86), p0.0010.81 (0.78,0.85)favors des*random effects (i2=71%)fixed effectsmean f/u 2.5 yrsajay j. kirtane and gregg w. stone, 2008note: weights are from random effects analysisd+l overall (i-squared = 75.9%, p = 0.000)northern new england (adjusted)ghost (adjusted)i-v overallmulticenter

37、 svg (adjusted)ny state (adjusted, unmatched)stent (adjusted)western denmark (adjusted)liverpool (matched)wake forest (adjusted)real (adjusted)study idmassachusetts (matched)italian diabetic multivessel (adjusted)midas (adjusted)asan korea (adjusted)nhlbi (on label, adjusted)mcmaster stemi (adjusted

38、)ontario (matched)washington hosp center (matched)nhlbi (off label, adjusted)scaar (adjusted)0.79 (0.71, 0.89)0.51 (0.26, 1.00)0.55 (0.36, 0.83)0.82 (0.79, 0.86)1.33 (0.47, 3.76)0.84 (0.72, 0.97)0.69 (0.55, 0.87)1.00 (0.86, 1.17)0.45 (0.24, 0.84)0.72 (0.55, 0.95)0.83 (0.70, 0.98)es (95% ci)0.79 (0.7

39、1, 0.89)1.22 (0.36, 4.10)0.66 (0.59, 0.74)0.60 (0.46, 0.79)1.47 (0.87, 2.48)0.17 (0.03, 0.97)0.71 (0.59, 0.84)1.16 (0.78, 1.75)0.94 (0.64, 1.38)1.03 (0.94, 1.14)100.002.154.111.048.18%6.838.102.406.097.86(d+l)8.710.788.716.143.100.40weight7.724.264.508.930.79 (0.71, 0.89)0.51 (0.26, 1.00)0.55 (0.36, 0.83)0.82 (0.79, 0.86)1.33 (0.47, 3.76)0.84 (0.72, 0.97)0.69 (0.55, 0.87)1.00 (0.86, 1.17)0.45 (0.24, 0.84)0.72 (