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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 UPDATE药物洗脱支架进展来自真实世界的数据分析Textbook & TheoryDrug-eluting StentsDrug based therapeuticsBare-metal StentsEvolution of CardiologyThe Era of Drug-eluting Stents药物洗脱支架
2、进展来自真实世界的数据分析More CAD patients prefer DESI prefer a less invasive and more comfortable therapyThe Era of Drug-eluting Stents药物洗脱支架进展来自真实世界的数据分析 In the praise of DES, controversies never stopThe Era of Drug-eluting Stents Safety and effectiveness: Remained unanswered DES vs. BMS: Different results fr
3、om different RCTs DES vs. CABG: 3 RCTs are ongoing药物洗脱支架进展来自真实世界的数据分析Editorials in NEJM on safety and efficacy of DESThe Era of Drug-eluting Stents药物洗脱支架进展来自真实世界的数据分析Restate the indication for DES CYPHER: target lesion 30 mm TAXUS: target lesion 28 mm The Era of Drug-eluting Stents药物洗脱支架进展来自真实世界的数据分
4、析 What is the current status of DES in the real-world?The Era of Drug-eluting Stents药物洗脱支架进展来自真实世界的数据分析Too perfect designed to consider the difference among hospitals, physiciansEnrolled patients are relative healthier and exclude patients at high riskSelection bias and uncontrolled, but can reflex
5、the truth in the real-worldThe Era of Drug-eluting Stents药物洗脱支架进展来自真实世界的数据分析 DES in The Real-world药物洗脱支架进展来自真实世界的数据分析 DES in The Real-world药物洗脱支架进展来自真实世界的数据分析 DES in The Real-world药物洗脱支架进展来自真实世界的数据分析 DES in The Real-world药物洗脱支架进展来自真实世界的数据分析A revolution brought by DES ? DES seems to be an optimal cho
6、ice * 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-world药物洗脱支架进展来自真实世界的数据分析Data analysis from New York State Registry Database DES in The Real-w
7、orld药物洗脱支架进展来自真实世界的数据分析TRIAL 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 Real-world药物洗脱支架进展来自真实世界的数据分析DES: 18-
8、mth rate of revascularization 30% DES in The Real-world药物洗脱支架进展来自真实世界的数据分析18-mth Survival AnalysisCABG is superior to DES in term of Total Mortality DES in The Real-world药物洗脱支架进展来自真实世界的数据分析18-mth Survival Analysis for MICABG is superior to DES in term of Myocardial Infarction DES in The Real-world药物
9、洗脱支架进展来自真实世界的数据分析Subgroup Analysis DES in The Real-world药物洗脱支架进展来自真实世界的数据分析nCABG 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 choose
10、s a less invasive option. DES in The Real-world药物洗脱支架进展来自真实世界的数据分析nWe would like 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 becaus
11、e there is evidence of very late stent thrombosis in patients receiving DES. DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Data 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药物洗脱支架进展来自
12、真实世界的数据分析 TRIAL DESIGN Patients （20042005) Statistical Analysis 3709 multi-vessel patients CABG (n=1875) DES (n=1834)Follow-up achieved in 98.0% 22.29.8 months Propensity AnalysisKaplan-Meier method Cox proportional hazards modelsOutcome measures Total mortality Repeated revascularization Target-ves
13、sel revascularization Q-wave myocardial InfarctionData analysis from Fuwai Hospital Registry Database DES in The Real-world药物洗脱支架进展来自真实世界的数据分析 DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Cumulative event rates during follow-up period DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Survival Analysis for Total Mo
14、rtality DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Survival Analysis for Revascularization DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Logrank P 0.0001Survival Analysis for TVR DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Survival Analysisfor Q-wave MI DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Favors CABGFavors D
15、ESSubgroup Analysis: Cox model with PS stratification DES in The Real-world药物洗脱支架进展来自真实世界的数据分析Conclusions 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 Revascularization TVR Q-wave
16、MI 药物洗脱支架进展来自真实世界的数据分析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 2005药物洗脱支架进展来自真实世界的数据分析LIMAThe 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
17、于相当于DES 1年通畅率年通畅率Tatoulis Tatoulis JTCVS,2004JTCVS,2004Discussion and Comment药物洗脱支架进展来自真实世界的数据分析CABG, 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
18、 InvasiveExcellent perioperative outcomesSatisfactory long-term benefits Becoming less invasiveThe safety and effectiveness confirmed by 30 years of experiences药物洗脱支架进展来自真实世界的数据分析Concerns on DES appear Discussion and CommentDoes DES bring a fundamental revolution to the PCI?Reduce the rate of stent
19、restenosisLead to early and very late stent thrombosisIntensive post-DES anticoagulation bring new complicationsSafety requiring longer-term follow-up药物洗脱支架进展来自真实世界的数据分析Discussion and CommentCover of LANCET Jan 2006Why so many CABG indicated patients receive PCI at last?In the real-world, do CAD pat
20、ients receive optimal treatment?Moral issuesInterestsQualification 药物洗脱支架进展来自真实世界的数据分析We keep running, but one point has never been We keep running, but one point has never been changed, that ischanged, that isDiscussion and Comment药物洗脱支架进展来自真实世界的数据分析SafetyTraumaCostEffectiveness “Patients always first” is every physicians first mission Discussion and Comment药物洗脱支架进展来自真实世界的数据分析Thank you药物洗脱支架进展来自真实世界的数据分析
