PARTNER试验解读.ppt
BACKGROUND: Valvular heart disease isincreasingly commonEffective treatment of valvular heart disease is still being developedThe valved stent is one possible treatmentThe 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 diseaseNowadays,the use of the valved stent in treating aortic stenosis is widelyBACKGROUND: 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。 PARTNER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 S3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。 PARTNER 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 NCT00530894.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 117%. FINDINGS:At 5 years： risk of death are similar：678% TAVR VS 624% SAVR. We recorded no structural valve deterioration requiring surgical valve replacement in either group. The rates of major stroke in the transcatheter group and the surgical group are similar（HR = 1.14;95% CI,0.68-1.93). Moderate or severe aortic regurgitation : 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p 8 或心脏组决定中风险组 (S3i): STS 评分4并8或心脏组决定超声心动图确定的重度主动脉狭窄: 瓣膜面积 0.8 cm2 或瓣膜面积指数 40mmHg 或峰值速度 4 m/s瓣膜返流: S3HR & S3i（瓣膜植入患者）0.1%轻度中度重度30天回声数可评价回声百分比无/痕量96.3%96.3%4%4%30天中度/重度 PVL Edwards SAPIEN 值PARNET I 、 II 试验低低30天时全因死亡率Edwards SAPIEN 值 (如治疗患者) PARTNER I 和 II 试验总体及TF 患者手手术术后后 30 天天数据数据：手术后 30 天，96.3% 患者未发现或仅有轻微瓣周反流，3.7% 患者出现中度反流，未发现严重反流。中度及严重程度瓣膜泄露合并风险发生率低于4%。术后30天，中度/重度 PVL在S3-HR组和S3-I的发生率分别为2.9%，4.2%。S3-HR组的30天全因死亡率为2.2%，心脏死亡率为1.4%。在高危和不可手术患者（S3-HR）中，SAPIEN 3 TAVR系统显示了30天良好的临床转归；在中危患者组（S3-I），SAPIEN 3的30天死亡率（1.1%）和卒中发生率（致残性卒中：1.0%）也很低。这种新型瓣膜在手术高危患者中较前2代器械有更低的死亡、卒中和瓣周漏发生率，其在中危患者中也显示了令人鼓舞的结果。结论l 在手术高风险及无法手术患者中 (S3HR), SAPIEN 3 TAVR 显示出30天低死亡率及低卒中率，以及卓越的临床结局。l 在中风险组患者中 (S3i), SAPIEN 3 显示出30天极低死亡率及卒中率。l SAPIEN 3导致的严重瓣膜返流( S3HR & S3i) 罕见
