5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial
5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial
复制标题
DOI：
10.1016/s0140-6736(15)60308-7
复制
发表时间：
2015-06-20
期刊：
影响因子：
168.9
通讯作者：
Svensson, Lars G.
中科院分区：
文献类型：
--
作者：
Mack, Michael J.;Leon, Martin B.;Svensson, Lars G.
背景 经导管主动脉瓣置入术 (PARTNER) 试验表明，对于主动脉瓣狭窄高危患者，经导管主动脉瓣置换术 (TAVR) 或手术主动脉瓣置换术 (SAVR) 1 年、2 年和 3 年的死亡率大致相同。我们在此报告 5 年结果。方法 我们在加拿大（2 家）、德国（1 家）和美国（23 家）的 25 家医院进行了这项随机对照试验。我们使用计算机生成的随机序列，通过经股动脉或经心尖入路，将严重主动脉瓣狭窄的高危患者随机分配至 SAVR 或采用球囊扩张牛心包组织瓣膜的 TAVR。患者和他们的主治医生不会被掩盖治疗分配情况。该试验的主要结果是意向治疗人群 1 年时的全因死亡率，我们在此介绍 5 年时的预定义结果。该研究已在 ClinicalTrials.gov 注册，编号为 NCT00530894。 结果 我们筛查了 3105 名患者，其中 699 名患者入组（348 名分配至 TAVR，351 名分配至 SAVR）。胸外科医生协会预测死亡风险的总体平均评分为 11.7%。 5 年时，TAVR 组的死亡风险为 67.8%，而 SAVR 组为 62.4%（风险比 1.04，95% CI 0.86-1.24；p = 0.76）。我们记录到两组中均未出现需要手术瓣膜置换的结构性瓣膜恶化。 TAVR 组 280 名患者中有 40 名患者 (14%) 发生中度或重度主动脉瓣关闭不全，SAVR 组 228 名患者中有 2 名患者 (1%) 发生中度或重度主动脉瓣关闭不全 (p < 0.0001)，并且与 TAVR 组 5 年死亡率风险增加相关（中度或重度主动脉瓣关闭不全患者为 72.4%，而轻度主动脉瓣关闭不全患者为 56.6%； p = 0.003).我们的解释 研究结果表明，TAVR 作为高手术风险患者手术的替代方案会产生相似的临床结果。资助 Edwards Lifesciences。
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 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 was all-cause mortality 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 11.7%. At 5 years, risk of death was 67.8% in the TAVR group compared with 62.4% in the SAVR group (hazard ratio 1.04, 95% CI 0.86-1.24; p = 0.76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p < 0.0001), and was associated with increased 5-year risk of mortality in the TAVR group (72.4% for moderate or severe aortic regurgitation vs 56.6% for those with mild aortic regurgitation or less; p = 0.003).Interpretation Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.Funding Edwards Lifesciences.