Cleveland Clinic, Cleveland, OH, USA.
Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
Lancet. 2015 Jun 20;385(9986):2485-91. doi: 10.1016/S0140-6736(15)60290-2. Epub 2015 Mar 15.
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.
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.
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<0·0001). 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.
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.
Edwards Lifesciences.
基于 Placement of Aortic Transcatheter Valves（PARTNER）试验的早期结果，经导管主动脉瓣置换术（TAVR）已被接受用于治疗不适合手术的严重主动脉瓣狭窄患者。然而，关于此类患者的晚期临床结局的信息很少。
我们在加拿大、德国和美国的 21 个有经验的瓣膜中心进行了这项随机对照试验。我们招募了患有严重症状性不可手术的主动脉瓣狭窄的患者，并将其随机分配（1:1）接受经股 TAVR 或标准治疗，标准治疗通常包括球囊主动脉瓣成形术。患者及其治疗医生对治疗分配不知情。随机化是在中央进行的，只有在患者经过筛选、同意并进入数据库后，各中心才了解到分配情况。该试验的主要结局为意向治疗人群中 1 年的全因死亡率，这里我们报告了 5 年后的预设发现。这项研究在 ClinicalTrials.gov 注册，编号为 NCT00530894。
我们对 3015 名患者进行了筛选，其中 358 名患者入组（平均年龄 83 岁，胸外科医师协会预测死亡率 11.7%，54%为女性）。179 名患者被分配接受 TAVR 治疗，179 名患者被分配接受标准治疗。20 名患者从标准治疗组交叉到 TAVR 组，10 名患者退出研究，仅在 5 年后有 6 名患者，其中 5 名患者在研究之外接受了主动脉瓣置换治疗。TAVR 组 5 年全因死亡率为 71.8%，而标准治疗组为 93.6%（风险比 0.50，95%CI 0.39-0.65；p<0.0001）。在 TAVR 组中，49 名存活患者中有 42 名（86%）在 5 年后出现纽约心脏协会（NYHA）心功能分级 1 或 2 级症状，而标准治疗组中仅有 5 名（60%）患者出现这种情况。TAVR 后的超声心动图显示持久的血液动力学获益（5 年后主动脉瓣口面积 1.52cm²，5 年后平均梯度 10.6mmHg），没有结构性瓣膜恶化的证据。
TAVR 比标准治疗更有益于治疗无法手术的主动脉瓣狭窄。对于不适合主动脉瓣置换术的主动脉瓣狭窄患者，应强烈考虑 TAVR，以提高其生存率和功能状态。对患者进行适当选择将有助于最大限度地发挥 TAVR 的益处，并降低严重合并症导致的死亡率。
爱德华兹生命科学公司。
