瑞士伯尔尼大学医院Thomas Pilgrim团队在最新研究中，比较了自膨式ACURATE neo和球囊式SAPIEN 3 TAVR系统的早期安全性和有效性。相关论文2019年9月27日在线发表于《柳叶刀》。

经导管主动脉瓣置换术（TAVR）是老年症状性严重主动脉瓣狭窄患者的首选治疗方案。现有TAVR系统特性的差异会影响临床结果。

研究组在德国、荷兰、瑞士和英国的20个三级心脏瓣膜中心进行了这项随机、非劣效性试验。2017年2月8日至2019年2月2日，研究组共招募了739名符合条件的参与者，年龄超过75岁，伴有症状性严重主动脉瓣狭窄，接受经股动脉TAVR，评估手术风险增加。参与者被随机分组，其中372名接受自膨式ACURATE neo TAVR系统，367名接受球囊式SAPIEN 3 TAVR系统。

两组中各有99%的患者完成了30日随访。在30天内，ACURATE neo组中有87例（24%）患者出现全因死亡、中风、危及生命或致残性出血、主要血管并发症、需要干预的冠状动脉阻塞、急性肾损伤（2或3期）、心脏瓣膜相关症状或充血性心力衰竭、需要再次手术的瓣膜相关功能障碍、中重度人工瓣膜返流或人工瓣膜狭窄的再住院治疗，显著高于SAPIEN 3组（60例，16%）。

对上述结果进行二次分析，SAPIEN 3装置显著优于ACURATE neo装置。两组患者的全因死亡和中风的发生率无显著差异，ACURATE neo组的急性肾损伤和中重度人工主动脉瓣反流的发生率显著高于SAPIEN 3组。

总之，在早期安全性和临床疗效方面，与球囊扩张SAPIEN 3装置相比，自膨式的ACURATE neo装置并不具有非劣效性，该结果有助于区分不同TAVR系统的性能。

附：英文原文

Title: Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Author: Jonas Lanz, MD *,Won-Keun Kim, MD *,Prof Thomas Walther, MD,Christof Burgdorf, MD,Helge Möllmann, MD,Prof Axel Linke, MD,Prof Simon Redwood, MD,Christian Thilo, MD,Michael Hilker, MD,Michael Joner, MD,Holger Thiele, MD,Lars Conzelmann, MD,Lenard Conradi, MD,Sebastian Kerber, MD,Gerhard Schymik, MD,Bernard Prendergast, MD,Oliver Husser, MD,Stefan Stortecky, MD,Dik Heg, PhD,Prof Peter Jüni, MD,Prof Stephan Windecker, MD,Thomas Pilgrim, MD,for the SCOPE I investigators†

Issue&Volume: 2019/09/27

Summary: 

Background

Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy.

Methods

In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting.

Findings

Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6–5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference −1·3 to −12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group.

Interpretation

TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems.

DOI: 10.1016/S0140-6736(19)32220-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32220-2/fulltext