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1、Concerns from Data Analysis in the Real-World Shengshou Hu M.D., FACC Department of Cardiac Surgery Fu Wai Hospital, Beijing, ChinaDES 2007 UPDATETextbook & TheoryDrug-eluting StentsDrug based therapeuticsBare-metal StentsEvolution of CardiologyThe Era of Drug-eluting StentsMore CAD patients prefer
2、DESI prefer a less invasive and more comfortable therapyThe Era of Drug-eluting Stents In the praise of DES, controversies never stopThe Era of Drug-eluting Stents Safety and effectiveness: Remained unanswered DES vs. BMS: Different results from different RCTs DES vs. CABG: 3 RCTs are ongoingEditori
3、als in NEJM on safety and efficacy of DESThe Era of Drug-eluting StentsRestate the indication for DES CYPHER: target lesion 30 mm TAXUS: target lesion 28 mm The Era of Drug-eluting Stents What is the current status of DES in the real-world?The Era of Drug-eluting StentsToo perfect designed to consid
4、er the difference among hospitals, physiciansEnrolled patients are relative healthier and exclude patients at high riskSelection bias and uncontrolled, but can reflex the truth in the real-worldThe Era of Drug-eluting Stents DES in The Real-world DES in The Real-world DES in The Real-world DES in Th
5、e Real-worldA revolution brought by DES ? DES seems to be an optimal choice * DES reduces rate of stent restenosis compared with BMS. * How much will DES benefit patients in the real-world? * Can DES maintain its advantage compared with bypass in the real-world? DES in The Real-worldData analysis fr
6、om New York State Registry Database DES in The Real-worldTRIAL DESIGN Patients Statistical Analysis 17400 multi-vessel patients DES n=9,963 (at least one DES) CABG n=7,437Follow-up achieved in 99.0% 18 months 1)Propensity Analysis2)Kaplan-Meier method 3)Cox proportional hazards models DES in The Rea
7、l-worldDES: 18-mth rate of revascularization 30% DES in The Real-world18-mth Survival AnalysisCABG is superior to DES in term of Total Mortality DES in The Real-world18-mth Survival Analysis for MICABG is superior to DES in term of Myocardial Infarction DES in The Real-worldSubgroup Analysis DES in
8、The Real-worldnCABG remains the standard of care for patients who require multivessel coronary revascularization. However, stents may be an alternative for patients at high risk for surgical complications or when an informed patient chooses a less invasive option. DES in The Real-worldnWe would like
9、 to have used a longer follow-up period. Nevertheless, it would appear that the advantage of CABG would have persisted over the course of another year or two of follow-up, because our evidence of that tendency and because there is evidence of very late stent thrombosis in patients receiving DES. DES
10、 in The Real-worldData analysis from Fuwai Hospital Registry DatabaseSurgical volume by yearPCI volume by yearCABG Database：over 6000 casesStent Database：over 7000 cases DES in The Real-world TRIAL DESIGN Patients （20042005) Statistical Analysis 3709 multi-vessel patients CABG (n=1875) DES (n=1834)F
11、ollow-up achieved in 98.0% 22.29.8 months Propensity AnalysisKaplan-Meier method Cox proportional hazards modelsOutcome measures Total mortality Repeated revascularization Target-vessel revascularization Q-wave myocardial InfarctionData analysis from Fuwai Hospital Registry Database DES in The Real-
12、world DES in The Real-worldCumulative event rates during follow-up period DES in The Real-worldSurvival Analysis for Total Mortality DES in The Real-worldSurvival Analysis for Revascularization DES in The Real-worldLogrank P 0.0001Survival Analysis for TVR DES in The Real-worldSurvival Analysisfor Q
13、-wave MI DES in The Real-worldFavors CABGFavors DESSubgroup Analysis: Cox model with PS stratification DES in The Real-worldConclusions DES in The Real-world CABG Patients were sicker Being older More co-morbidities Poorer LV function DES patients had higher rates of adverse outcomes Total mortality
14、 Revascularization TVR Q-wave MI Discussion and CommentWhat is the Differences between Bypass and PCI PCI is targeted at the “culprit” lesion or lesions. CABG is directed at the vessel including lesions and future culprits.March 2005LIMAThe Golden Standard for LAD10年通畅率年通畅率95%15年通畅率年通畅率94 相当于相当于DES
15、1年通畅率年通畅率TatoulisTatoulis JTCVS,2004JTCVS,2004Discussion and CommentCABG, the standard method for coronary revascularizationFuwai DatabaseDiscussion and Comment0.6% MortalityBypass surgeryOn-pump CABG Off-pump technique Mimi-incision Port-access Fast tract anesthesia Less InvasiveExcellent periopera
16、tive outcomesSatisfactory long-term benefits Becoming less invasiveThe safety and effectiveness confirmed by 30 years of experiencesConcerns on DES appear Discussion and CommentDoes DES bring a fundamental revolution to the PCI?Reduce the rate of stent restenosisLead to early and very late stent thr
17、ombosisIntensive post-DES anticoagulation bring new complicationsSafety requiring longer-term follow-upDiscussion and CommentCover of LANCET Jan 2006Why so many CABG indicated patients receive PCI at last?In the real-world, do CAD patients receive optimal treatment?Moral issuesInterestsQualification
18、 We keep running, but one point has never been We keep running, but one point has never been changed, that ischanged, that isDiscussion and CommentSafetyTraumaCostEffectiveness “Patients always first” is every physicians first mission Discussion and CommentThank you待情绪稍微冷静后，阿元才略带平稳的语气地说：“没错。他是个小有名气的
19、铸剑师，也是个酒鬼，”她说着解开头上的围巾，一条暗红色骇人的疤痕从脖颈根部一直延伸到锁骨中心，同阿元白皙的肌肤形成对比，但她很快又把围巾重新围上，说：“那天晚上我和他发生了争执，酒气熏熏的他不知用什么东西把我打昏。后来，虽然我被一个医生救活了，但是我的心却死了。那个男人不仅给我留下了这条疤痕，还带走了我的女儿”阿元的语气冰冷，与之前温和的样子截然相反。“带走？”白术不解。“我醒来后，别人告诉我，我的丈夫和女儿都失踪了。所以我猜测，可能是被他带走了，也可能是被他杀掉了。”“也有可能是你的女儿自己逃跑了。”白术接下去说。阿元抱住自己的臂膀，低下头说无限悲哀地说：“不管是哪一点，总之，生不见人，死不
20、见尸。”“从那天之后，”阿元继续说：“我努力忘记过去，忘记那天晚上发生的事情。我在冰冷的孤独中生活了七年，一直在寻找着女儿，就算那希望如同蛛丝一样细弱，我也一直在寻找下去。如果不是那个医生救活了我，就算我死了也不会安息的。”阿元叹气，道：“关于过去，我已经几乎快忘光了。若不是你来问我，大概我再也不会记起了。”“很抱歉”白术真心诚意地向阿元致歉。阿元摇摇头，道：“不也许也是好事，因为那个医生的名字也差点被我忘了。”“名字？”“嗯，那个恩人的名字，”阿元稍稍露出微笑，道：“我没有见过他。醒来之后，一直照顾我的邻居说，那个大夫的名字叫厚朴。”“什么？”惊诧同难以言表的微喜混合着一道向白术袭来。他顿时
21、觉得逝去的时间在他的面前急速倒流，一个模糊而熟悉的身影在远处微微转身。一切似乎触手可及。“是啊，听说大夫姓白那么全名就叫白厚朴了。”那是白术失踪的父亲的名字。没想到，在七年前的某日，自己的父亲还救过一个濒死的女人。而这个女人，目前所知唯一遇见过父亲的女人，正站在自己的面前。与此同时，这个女人很有可能是楼上失忆少女的母亲。“白厚朴是我的父亲我以为他失踪了。”白术的嘴角柔和地上翘，显出好看的弧度。“您您是恩公的儿子么？”阿元也惊喜万分。“没错。”“感谢您父亲的救命之恩。”阿元朝白术跪下，但白术将女人扶起。阿元哽咽着说：“该怎样报答您才好呢？”待情绪稍微冷静后，阿元才略带平稳的语气地说：“没错。他是
22、个小有名气的铸剑师，也是个酒鬼，”她说着解开头上的围巾，一条暗红色骇人的疤痕从脖颈根部一直延伸到锁骨中心，同阿元白皙的肌肤形成对比，但她很快又把围巾重新围上，说：“那天晚上我和他发生了争执，酒气熏熏的他不知用什么东西把我打昏。后来，虽然我被一个医生救活了，但是我的心却死了。那个男人不仅给我留下了这条疤痕，还带走了我的女儿”阿元的语气冰冷，与之前温和的样子截然相反。“带走？”白术不解。“我醒来后，别人告诉我，我的丈夫和女儿都失踪了。所以我猜测，可能是被他带走了，也可能是被他杀掉了。”“也有可能是你的女儿自己逃跑了。”白术接下去说。阿元抱住自己的臂膀，低下头说无限悲哀地说：“不管是哪一点，总之，生
23、不见人，死不见尸。”“从那天之后，”阿元继续说：“我努力忘记过去，忘记那天晚上发生的事情。我在冰冷的孤独中生活了七年，一直在寻找着女儿，就算那希望如同蛛丝一样细弱，我也一直在寻找下去。如果不是那个医生救活了我，就算我死了也不会安息的。”阿元叹气，道：“关于过去，我已经几乎快忘光了。若不是你来问我，大概我再也不会记起了。”“很抱歉”白术真心诚意地向阿元致歉。阿元摇摇头，道：“不也许也是好事，因为那个医生的名字也差点被我忘了。”“名字？”“嗯，那个恩人的名字，”阿元稍稍露出微笑，道：“我没有见过他。醒来之后，一直照顾我的邻居说，那个大夫的名字叫厚朴。”“什么？”惊诧同难以言表的微喜混合着一道向白术袭来。他顿时觉得逝去的时间在他的面前急速倒流，一个模糊而熟悉的身影在远处微微转身。一切似乎触手可及。“是啊，听说大夫姓白那么全名就叫白厚朴了。”那是白术失踪的父亲的名字。没想到，在七年前的某日，自己的父亲还救过一个濒死的女人。而这个女人，目前所知唯一遇见过父亲的女人，正站在自己的面前。与此同时，这个女人很有可能是楼上失忆少女的母亲。“白厚朴是我的父亲我以为他失踪了。”白术的嘴角柔和地上翘，显出好看的弧度。“您您是恩公的儿子么？”阿元也惊喜万分。“没错。”“感谢您父亲的救命之恩。”阿元朝白术跪下，但白术将女人扶起。阿元哽咽着说：“该怎样报答您才好呢？”
