5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial
5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial
复制标题
DOI：
10.1016/s0140-6736(15)60290-2
复制
发表时间：
2015-06-20
期刊：
影响因子：
168.9
通讯作者：
Smith, Craig R.
中科院分区：
文献类型：
--
作者：
Kapadia, Samir R.;Leon, Martin B.;Smith, Craig R.
背景基于经导管主动脉瓣置入（PARTNER）试验的早期结果，经导管主动脉瓣置换术（TAVR）是不适合手术的重度主动脉瓣狭窄患者的公认治疗方法。然而，很少有信息是关于在这样的patients.Methods的后期临床结局，我们做了这项随机对照试验，在21个有经验的瓣膜中心在加拿大，德国，和美国。我们入组了患有严重症状性不可手术主动脉瓣狭窄的患者，并将其随机（1：1）分配至经股动脉TAVR或标准治疗组，通常包括球囊主动脉瓣成形术。患者及其主治医生不对治疗分配设盲。随机化集中进行，研究中心仅在患者接受筛选、签署知情同意书并输入数据库后才了解分配情况。该试验的主要结局是意向治疗人群1年时的全因死亡率，在此我们提供了5年后的预先规定的结果。本研究注册于ClinicalTrials.gov，编号NCT 00530894。结果我们筛选了3015例患者，其中358例入组（平均年龄83岁，胸外科医师协会预测死亡风险为11.7%，54%为女性）。179例被分配接受TAVR治疗，179例被分配接受标准治疗。20名患者从标准治疗组交叉，10名患者退出研究，5年时仅留下6名患者，其中5名患者在研究外接受了主动脉瓣置换治疗。TAVR组5年全因死亡风险为71.8%，标准治疗组为93.6%（风险比0.50，95%CI 0.39-0.65; p < 00001）。在5年时，TAVR组49名幸存者中有42名（86%）有纽约心脏协会1级或2级症状，而标准治疗组5名幸存者中有3名（60%）。TAVR后的超声心动图显示了持久的血液动力学获益（5年时主动脉瓣面积为1.52 cm（2），5年时平均跨瓣压差为10.6 mm Hg），没有结构性瓣膜退化的证据。对于不适合主动脉瓣置换术的患者，应强烈考虑TAVR，以改善其生存和功能状态。适当选择患者将有助于最大限度地提高TAVR的获益，并降低重度合并症的死亡率。
Background Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients.Methods We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned (1: 1) them to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty. Patients and their treating physicians were not masked to treatment allocation. The randomisation was done centrally, and sites learned of the assignment only after a patient had been screened, consented, and entered into the database. The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population, here we present the prespecified findings after 5 years. This study is registered with ClinicalTrials.gov, number NCT00530894.Findings We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11.7%, 54% female). 179 were assigned to TAVR treatment and 179 were assigned to standard treatment. 20 patients crossed over from the standard treatment group and ten withdrew from study, leaving only six patients at 5 years, of whom five had aortic valve replacement treatment outside of the study. The risk of all-cause mortality at 5 years was 71.8% in the TAVR group versus 93.6% in the standard treatment group (hazard ratio 0.50, 95% CI 0.39-0.65; p < 00001). At 5 years, 42 (86%) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three (60%) of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 1.52 cm(2) at 5 years, mean gradient 10.6 mm Hg at 5 years), with no evidence of structural valve deterioration.Interpretation TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities.