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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, China,DES 2007 UPDATE,Textbook & Theory,Drug-eluting Stents,Drug based therapeutics,Bare-metal Stents,Evolution of Cardiology,The Era of Drug-eluting Stents,More CAD patients
2、 prefer DES,I prefer a less invasive and more comfortable therapy,The Era of Drug-eluting Stents,In the praise of DES, controversies never stop,The Era of Drug-eluting Stents,Safety and effectiveness: Remained unanswered DES vs. BMS: Different results from different RCTs DES vs. CABG: 3 RCTs are ong
3、oing,Editorials in NEJM on safety and efficacy of DES,The Era of Drug-eluting Stents,Restate 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 Stents,Too perfect de
4、signed to consider the difference among hospitals, physicians,Enrolled patients are relative healthier and exclude patients at high risk,Selection bias and uncontrolled, but can reflex the truth in the real-world,The Era of Drug-eluting Stents,DES in The Real-world,DES in The Real-world,DES in The R
5、eal-world,DES in The Real-world,A 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-w
6、orld,Data analysis from New York State Registry Database,DES in The Real-world,TRIAL DESIGN,Patients Statistical Analysis,17400 multi-vessel patients DES n=9,963 (at least one DES) CABG n=7,437 Follow-up achieved in 99.0% 18 months,Propensity Analysis Kaplan-Meier method Cox proportional hazards mod
7、els,DES in The Real-world,DES: 18-mth rate of revascularization 30%,DES in The Real-world,18-mth Survival Analysis,CABG is superior to DES in term of Total Mortality,DES in The Real-world,18-mth Survival Analysis for MI,CABG is superior to DES in term of Myocardial Infarction,DES in The Real-world,S
8、ubgroup Analysis,DES in The Real-world,CABG 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
9、Real-world,We 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 because there is evidence of very late stent thrombosis in pat
10、ients receiving DES.,DES in The Real-world,Data analysis from Fuwai Hospital Registry Database,Surgical volume by year,PCI volume by year,CABG Database：over 6000 cases,Stent Database：over 7000 cases,DES in The Real-world,TRIAL DESIGN,Patients （20042005) Statistical Analysis,3709 multi-vessel patient
11、s CABG (n=1875) DES (n=1834) Follow-up achieved in 98.0% 22.29.8 months,Propensity Analysis Kaplan-Meier method Cox proportional hazards models,Outcome measures,Total mortality Repeated revascularization Target-vessel revascularization Q-wave myocardial Infarction,Data analysis from Fuwai Hospital R
12、egistry Database,DES in The Real-world,DES in The Real-world,Cumulative event rates during follow-up period,DES in The Real-world,Survival Analysis for Total Mortality,DES in The Real-world,Survival Analysis for Revascularization,DES in The Real-world,Logrank P 0.0001,Survival Analysis for TVR,DES i
13、n The Real-world,Survival Analysis for Q-wave MI,DES in The Real-world,Favors CABG,Favors DES,Subgroup Analysis: Cox model with PS stratification,DES in The Real-world,Conclusions,DES in The Real-world,CABG Patients were sicker,Being older More co-morbidities Poorer LV function,DES patients had high
14、er rates of adverse outcomes,Total mortality Revascularization TVR Q-wave MI,Discussion and Comment,What 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,LIMAThe Golden Stand
15、ard for LAD,10年通畅率95% 15年通畅率94 相当于DES 1年通畅率,Tatoulis JTCVS,2004,Discussion and Comment,CABG, the standard method for coronary revascularization,Fuwai Database,Discussion and Comment,0.6% Mortality,Bypass surgery On-pump CABG Off-pump technique Mimi-incision Port-access Fast tract anesthesia,Less Inv
16、asive,Excellent perioperative outcomes Satisfactory long-term benefits Becoming less invasive,The safety and effectiveness confirmed by 30 years of experiences,Concerns on DES appear,Discussion and Comment,Does DES bring a fundamental revolution to the PCI?,Reduce the rate of stent restenosis Lead t
17、o early and very late stent thrombosis Intensive post-DES anticoagulation bring new complications Safety requiring longer-term follow-up,Discussion and Comment,Cover of LANCET Jan 2006,Why so many CABG indicated patients receive PCI at last?,In the real-world, do CAD patients receive optimal treatment?,Moral issues Interests Qualification ,We keep running, but one point has never been changed, that is,Discussion and Comment,Safety,Trauma,Cost,Effectiveness,“Patients always first” is every physicians first mission,Discussion and Comment,Thank you,