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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.
The Lancet ( IF 98.4 ) Pub Date : 2019-09-27 , DOI: 10.1016/s0140-6736(19)32220-2 Jonas Lanz 1 , Won-Keun Kim 2 , Thomas Walther 3 , Christof Burgdorf 4 , Helge Möllmann 5 , Axel Linke 6 , Simon Redwood 7 , Christian Thilo 8 , Michael Hilker 9 , Michael Joner 10 , Holger Thiele 11 , Lars Conzelmann 12 , Lenard Conradi 13 , Sebastian Kerber 14 , Gerhard Schymik 15 , Bernard Prendergast 7 , Oliver Husser 5 , Stefan Stortecky 1 , Dik Heg 16 , Peter Jüni 17 , Stephan Windecker 1 , Thomas Pilgrim 1 ,
The Lancet ( IF 98.4 ) Pub Date : 2019-09-27 , DOI: 10.1016/s0140-6736(19)32220-2 Jonas Lanz 1 , Won-Keun Kim 2 , Thomas Walther 3 , Christof Burgdorf 4 , Helge Möllmann 5 , Axel Linke 6 , Simon Redwood 7 , Christian Thilo 8 , Michael Hilker 9 , Michael Joner 10 , Holger Thiele 11 , Lars Conzelmann 12 , Lenard Conradi 13 , Sebastian Kerber 14 , Gerhard Schymik 15 , Bernard Prendergast 7 , Oliver Husser 5 , Stefan Stortecky 1 , Dik Heg 16 , Peter Jüni 17 , Stephan Windecker 1 , Thomas Pilgrim 1 ,
Affiliation
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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.
FUNDING
Boston Scientific (USA).
中文翻译：
有症状的严重主动脉瓣狭窄患者中自扩张式与球囊扩张式生物假体在经导管主动脉瓣置换术中的安全性和有效性：一项随机性非劣效性试验。
背景技术经导管主动脉瓣置换术（TAVR）是有症状的严重主动脉瓣狭窄的老年患者的首选治疗选择。可用的TAVR系统的属性差异会影响临床结果。在接受TAVR的患者中，我们就早期安全性和疗效比较了自扩张式ACURATE neo TAVR系统和球囊扩张式SAPIEN 3 TAVR系统。方法在这项随机性，非劣效性试验中，在德国的20个三级心脏瓣膜中心招募了经股动脉TAVR治疗（≥75岁）接受治疗的有症状的严重主动脉瓣狭窄且手术风险增加的患者（年龄≥75岁）。荷兰，瑞士和英国。参与者被随机分配（1：1）通过研究中心和胸外科医师预测的死亡风险（STS-PROM）类别分层，以基于计算机的随机排列的阻止方案接受ACURATE neo或SAPIEN 3的治疗。主要的安全性和有效性综合终点包括全因死亡，任何中风，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期或3期），因瓣膜相关症状而再次住院或充血性心力衰竭，与瓣膜相关的功能障碍需要重复手术，在手术后30天内出现中度或重度人工瓣膜返流或人工瓣膜狭窄。终点评估者对治疗分配不了解。在意向治疗人群中评估ACURATE neo与SAPIEN 3的非劣效性，主要复合终点的风险差异为7·7％，单侧α为0·05 。该试验已在ClinicalTrials.gov上注册（编号NCT03011346），正在进行中，但尚未募集。结果在2017年2月8日至2019年2月2日之间，共筛查了5132例患者和739例患者（平均年龄82·8岁[SD 4·1]; STS-PROM评分中位数3·5％[IQR 2·6- 5·0]）。分配给ACURATE neo组的372名患者中有367名（99％）有30天随访，分配给SAPIEN 3组的367名患者中有364名（99％）。在30天之内，ACURATE neo的主要终点发生在87名（24％）患者中，而SAPIEN 3组的60名（16％）患者发生了主要终点；因此，未满足ACURATE neo的非劣效性（绝对风险差异7·1％[95％置信区间上限12·0％]，p = 0·42）。主要终点的二次分析显示，SAPIEN 3设备优于ACURATE neo设备（风险差异-1·3至-12·9，95％CI，p = 0·0156）。ACURATE neo和SAPIEN 3组的全因死亡（9例[2％]对比3例[1％]）和中风（7例[2％]对比11 [3％]）的发生率没有差异。而在ACURATE neo组中，急性肾损伤（11 [3％]比三[1％]）和中度或严重的主动脉瓣关闭不全（34 [9％]比十[3％]）更为常见。就早期安全性和临床疗效结果而言，与球囊扩张型SAPIEN 3装置相比，具有自扩张型ACURATE neo的TAVR不能满足非劣效性。早期的复合安全性和有效性终点可用于区分不同TAVR系统的性能。资助波士顿科学公司（美国）。
更新日期：2019-11-01
中文翻译：
有症状的严重主动脉瓣狭窄患者中自扩张式与球囊扩张式生物假体在经导管主动脉瓣置换术中的安全性和有效性：一项随机性非劣效性试验。
背景技术经导管主动脉瓣置换术（TAVR）是有症状的严重主动脉瓣狭窄的老年患者的首选治疗选择。可用的TAVR系统的属性差异会影响临床结果。在接受TAVR的患者中，我们就早期安全性和疗效比较了自扩张式ACURATE neo TAVR系统和球囊扩张式SAPIEN 3 TAVR系统。方法在这项随机性，非劣效性试验中，在德国的20个三级心脏瓣膜中心招募了经股动脉TAVR治疗（≥75岁）接受治疗的有症状的严重主动脉瓣狭窄且手术风险增加的患者（年龄≥75岁）。荷兰，瑞士和英国。参与者被随机分配（1：1）通过研究中心和胸外科医师预测的死亡风险（STS-PROM）类别分层，以基于计算机的随机排列的阻止方案接受ACURATE neo或SAPIEN 3的治疗。主要的安全性和有效性综合终点包括全因死亡，任何中风，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期或3期），因瓣膜相关症状而再次住院或充血性心力衰竭，与瓣膜相关的功能障碍需要重复手术，在手术后30天内出现中度或重度人工瓣膜返流或人工瓣膜狭窄。终点评估者对治疗分配不了解。在意向治疗人群中评估ACURATE neo与SAPIEN 3的非劣效性，主要复合终点的风险差异为7·7％，单侧α为0·05 。该试验已在ClinicalTrials.gov上注册（编号NCT03011346），正在进行中，但尚未募集。结果在2017年2月8日至2019年2月2日之间，共筛查了5132例患者和739例患者（平均年龄82·8岁[SD 4·1]; STS-PROM评分中位数3·5％[IQR 2·6- 5·0]）。分配给ACURATE neo组的372名患者中有367名（99％）有30天随访，分配给SAPIEN 3组的367名患者中有364名（99％）。在30天之内，ACURATE neo的主要终点发生在87名（24％）患者中，而SAPIEN 3组的60名（16％）患者发生了主要终点；因此，未满足ACURATE neo的非劣效性（绝对风险差异7·1％[95％置信区间上限12·0％]，p = 0·42）。主要终点的二次分析显示，SAPIEN 3设备优于ACURATE neo设备（风险差异-1·3至-12·9，95％CI，p = 0·0156）。ACURATE neo和SAPIEN 3组的全因死亡（9例[2％]对比3例[1％]）和中风（7例[2％]对比11 [3％]）的发生率没有差异。而在ACURATE neo组中，急性肾损伤（11 [3％]比三[1％]）和中度或严重的主动脉瓣关闭不全（34 [9％]比十[3％]）更为常见。就早期安全性和临床疗效结果而言，与球囊扩张型SAPIEN 3装置相比，具有自扩张型ACURATE neo的TAVR不能满足非劣效性。早期的复合安全性和有效性终点可用于区分不同TAVR系统的性能。资助波士顿科学公司（美国）。
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