Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
JACC Cardiovasc Interv. 2016 Sep 12;9(17):1757-64. doi: 10.1016/j.jcin.2016.06.027.
This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System.
The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial.
Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016.
The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor.
Following panel discussions and the evidence presented, the panel voted for approval of the device.
本研究旨在描述美国食品和药物管理局（FDA）循环系统设备小组在 Absorb 生物可吸收血管支架（BVS）系统的上市前批准申请会议上的讨论和建议。
Absorb BVS 系统是首个完全生物可吸收的经皮冠状动脉介入治疗技术。Absorb BVS 在 ABSORB III（Absorb BVS 的临床评估，依维莫司洗脱生物可吸收血管支架治疗新发性原生冠状动脉病变的研究）试验中进行了研究，这是一项关键性的美国研究性器械豁免试验。
对 2016 年 3 月 15 日举行的 FDA 循环系统设备小组上市前批准申请会议的观察性报告。
美国 FDA 循环系统设备小组的成员审查了赞助商和 FDA 提交的 ABSROB III 试验结果和其他事后分析。ABSORB III 试验达到了主要终点，即与对照组 XIENCE 药物洗脱支架相比，Absorb BVS 在 1 年时的靶病变失败非劣效性。尽管 Absorb BVS 报告了更高的不良结果数值趋势，但 Absorb BVS 与 XIENCE 在靶病变失败或次要预先指定结果的任何安全性或有效性组成部分方面均无统计学差异。小组成员对 ABSORB III 结果和事后分析提出了关注，主要集中在试验的非劣效性设计、Absorb BVS 在小血管中的明显安全性问题、ABSORB III 中发现的血管大小的视觉与血管内成像评估之间的不匹配及其对适当设备标签的影响、特定患者和病变亚组中 Absorb BVS 的安全性以及赞助商的批准后承诺。
在小组讨论和提出的证据之后，小组投票赞成批准该设备。
