The Acurate neo2 transcatheter aortic valve replacement (TAVR) system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE:BSX) today announced that a study of its Acurate neo2 aortic valve system missed its primary endpoint.

Acurate neo2经导管主动脉瓣置换术（TAVR）系统。[图片由波士顿科学公司提供]波士顿科学公司（纽约证券交易所：BSX）今天宣布，对其急性neo2主动脉瓣系统的研究错过了其主要终点。

The ACURATE IDE study evaluated Acurate neo2, a transcatheter aortic valve replacement (TAVR) system, in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. Investigators presented data at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C..

ACURATE IDE研究评估了经导管主动脉瓣置换术（TAVR）系统ACURATE neo2治疗严重症状性主动脉瓣狭窄患者的低，中，高和极端风险的心内直视手术。研究人员在华盛顿特区的经导管心血管治疗（TCT）2024年会议上提供了数据。。

Acurate neo2, Boston Scientific’s second-generation TAVR technology, was cmopared to a pre-defined control valve. That included either the commercially available Edwards Sapien or Medtronic Evolut, selected at the discretion of the implanting physician.

波士顿科学公司（Boston Scientific）的第二代TAVR技术Acurate neo2被改装为预定义的控制阀。其中包括市售的Edwards Sapien或Medtronic Evolut，由植入医生自行选择。

Findings included a 16.16% composite rate of all-cause mortality, stroke or rehospitalization at one year in the Acurate neo2 arm. That compared to 9.53% in the control arm. This failed to meet the pre-specified criterion for non-inferiority. The study had a non-inferiority posterior probability of 77.9%, lower than the non-inferiority test threshold of 97.5%..

研究结果包括Acurate neo2组一年内全因死亡率，中风或再住院率为16.16%。而对照组为9.53%。这不符合预先规定的非劣效性标准。该研究的非劣效性后验概率为77.9%，低于非劣效性测试阈值97.5%。。

Boston Scientific looks to keep progressing Acurate neo2

波士顿科学公司（Boston Scientific）期待不断取得进展

Boston Scientific also reported data from a post-hoc analysis to identify and evaluate expanded and under-expanded Acurate neo2 frames. This highlighted that approximately 20% of valves were under-expanded. Data also showed a similar rate for death, stroke or rehospitalization at one year between the Acurate neo2 expanded group and the control.

Boston Scientific还报告了事后分析的数据，以识别和评估扩展的和未扩展的急性neo2框架。这突出表明，大约20%的阀门膨胀不足。。

However, those who remained under-expanded had worse outcomes..

然而，那些扩张不足的人的结果更差。。

“This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment,” said Dr. Michael Reardon, professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and co-principal investigator of the ACURATE IDE trial.

休斯顿卫理公会德巴基心脏与血管中心心胸外科教授兼ACURATE IDE试验联合首席研究员迈克尔·里登博士（MichaelReardon）说：“这项试验是TAVR平台最大规模的随机比较，历时四年，包括在全球大流行期间，这给登记带来了复杂性。”。

“These data add to the breadth of clinical knowledge of the ACURATE valve platform and provide compelling insights on the importance of procedural optimization that will be beneficial for TAVR moving forward.”.

“这些数据增加了ACURATE瓣膜平台的临床知识的广度，并提供了关于程序优化重要性的令人信服的见解，这将有利于TAVR的发展。”。

The company said it plans to continue working with the FDA on a regulatory strategy to get the Acurate platform approved in the U.S.

该公司表示，计划继续与FDA合作制定监管策略，以使Acurate平台在美国获得批准。

“The data presented today give clinicians a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve,” said Dr. Janar Sathananthan, chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “We believe the findings from the ACURATE IDE post-hoc analysis and implementation of steps to mitigate valve under-expansion may improve outcomes for the ACURATE valve and have important implications on other commercially available TAVR valves, and we look forward to studying these improved techniques in future trials of the device.”.

波士顿科学公司介入心脏病学治疗首席医疗官Janar Sathananthan博士说：“今天提供的数据使临床医生更好地了解了TAVR空间继续快速发展时程序优化的影响。”。“我们相信ACURATE IDE事后分析的结果和缓解瓣膜扩张不足的步骤的实施可能会改善ACURATE瓣膜的结果，并对其他商业上可用的TAVR瓣膜产生重要影响，我们期待在未来的试验中研究这些改进的技术。该设备。”。

The analysts’ take

Needham analyst Mike Matson noted that the trial took place over 47 months during the height of the COVID-19 pandemic. He said that resutled in disruptions to enrollment and it prevented centers from building “adequate experience” with Acurate neo2.

Needham分析师迈克·马森（MikeMatson）指出，该试验发生在新型冠状病毒（COVID-19）大流行高峰期的47个多月内。他说，这导致招生中断，并阻止了各中心用急性neo2建立“足够的经验”。

Matson said the results are unlikely to have a significant impact on Boston Scientific’s international sales for Acurate neo2 (which he estimates come in at more than $350 million annually), as the results appear to reflect a learning curve or training issue. However, it may cast some doubt over the valve’s pathway through the FDA for U.S.

Matson表示，这些结果不太可能对波士顿科学公司Acurate neo2的国际销售额产生重大影响（他估计每年销售额超过3.5亿美元），因为这些结果似乎反映了学习曲线或培训问题。然而，它可能会对美国FDA通过阀门的途径产生一些疑问。

commercialization..

商业化。。

“It’s unclear what this means for FDA approval of ACURATE neo2 but we think approval is less likely and some sort of additional clinical data may be required,” Matson wrote.

Matson写道：“目前尚不清楚这对FDA批准ACURATE neo2意味着什么，但我们认为批准的可能性较小，可能需要一些额外的临床数据。”。