PARTNER试验教程分析.ppt

PARTNER Trial BACKGROUND: Valvular heart disease isincreasingly common．Effective treatment of valvular heart disease is still being developed．The valved stent is one possible treatment．The valved stent has many advantages that cannot be replicated by other known treatments，With continued research the valved stent will become the leading treatment for valvular heart disease．Nowadays,the use of the valved stent in treating aortic stenosis is widely． BACKGROUND: 3月15日，在美国心脏病协会（ACC） 2015最新临床试验瓣膜研究专场，PARTNER研究成为全场焦点。 PARTNERⅠ的5年转归数据提示:SAPIEN经导管心脏瓣膜是严重主动脉狭窄且开胸手术高危患者的可用选择； PARTNER ⅡS3显示:SAPIEN三代瓣膜改善了高危和中危患者30天主要终点转归。 PARTNERⅠ Trial BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. METHODS: We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR（，transcatheter aortic-valve replacement） or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NC FINDINGS: We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11?7%. FINDINGS: At 5 years： risk of death are similar：67?8% TAVR VS 62?4% SAVR. We recorded no structural valve det