在中国临床试验的案例分析.pptVIP

以高品质在真正的世界级临床试验中建立声誉： Endeavor 在中国临床试验的案例分析Top Quality Work Wins Credibility in True Global Clinical Trials - A Case Study of Endeavor Clinical Programs in China 阜外心血管病医院介入导管室 徐 波 Randomized Clinical Study Organization Anatomy Clinical Study Process ENDEAVOR Clinical Program Update E-Five Registry E-five Study Organization Anatomy E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry Clinical Outcomes Definition MACE is defined as death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA or CABG). TLR is defined as any clinically driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. TVF is defined as target vessel revascularization (defined below), recurrent Q or Non Q-Wave myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel. Target vessel failure will be reported when: 1. Recurrent MI occurs in territory not clearly other than that of the target vessel. 2. Cardiac death not clearly due to a non-target vessel endpoint. 3. Target vessel revascularization is determined. E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry E-Five Registry In Summary: The E-Five registry enrolled patients that represent the “real world” of PCI There have been independent event adjudication, performing 10% monitoring to detect underreporting of events The first 2000 patients has provided insight into the safety and efficacy of the Endeavor DES in a more complex patient population Conclusions: The Endeavor Drug Eluting Stent was associated with a low MACE and TLR in the first 1989 patients studied out to 12 months Despite the relative complexity of this patient cohort the safety outcomes – cardiac death, MI and stent thrombosis were also low These results are consistent with the outcomes repo