2007药物洗脱支架进展来自真实世界的数据分析

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 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 ongoing 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 designed 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 Real-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-world 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 1) Propensity Analysis 2) Kaplan-Meier method 3) Cox proportional hazards models 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 Subgroup 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 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 patients receiving DES. DES in The Real-world 010002000300040005000600070008000外科手术2002年 2003年 2004年2005年 2006年 2007年0200040006000800010000院所2 0 0 5 至2 0 0 7 年心脏介入量2005年 2006年 2007年010002000300040005000600070008000外科手术2002年 2003年 2004年2005年 2006年 2007年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 patients CABG (n=1875) DES (n=1834) Follow-up achieved in 98.0% 22.2 9.8 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 Registry 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 in 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 higher 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 Standard 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 Invasive 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 to 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 pati