Johns Hopkins University School of Medicine, Baltimore, MD.
Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
J Vasc Surg. 2023 Nov;78(5):1313-1321. doi: 10.1016/j.jvs.2023.07.050. Epub 2023 Jul 29.
Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.
注册评估外周血管介入器械（RAPID）启动了 Pathways 计划，提供了一个透明的、协作的论坛，以深入探讨紫杉醇涂层器械的获益-风险方面的多个未解决问题，包括了解死亡率信号的基础，而没有明确的潜在生物学机制，以及晚期死亡率信号是否可能是多个独立的前瞻性随机数据来源固有的内在假象，这些数据来源并没有将死亡作为长期终点进行预设。为了响应这一指令，LEAN-Case 报告表工作组专注于通过添加关键临床修饰符来增强 RAPID 第一阶段最小核心数据集，这些修饰符将与药物洗脱器械时代外周动脉疾病介入治疗后的长期死亡率结果更紧密地联系起来，目标是更准确地检查未来的死亡率信号。
