Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (E.A.S., A.R., C.S., L.R.V., R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA.
Division of Cardiology (E.A.S., R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA.
Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007040. doi: 10.1161/CIRCOUTCOMES.120.007040. Epub 2021 Jan 13.
Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries.
SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018. All patients age 66 years or older who underwent revascularization will be identified using a combination of procedural codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System C-codes. The safety end point of all-cause death will be updated semiannually and continued until the median duration of follow-up surpasses 5 years. Sub-group analyses will be conducted by device type, patient characteristics, and procedural setting. Registration: The SAFE-PAD study has been registered on URL: https://www.clinicaltrials.gov; Unique identifier: NCT04496544.
The SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.
最近来自随机对照试验的证据引起了对用于股腘动脉血运重建的紫杉醇涂层外周设备的长期安全性的担忧。为了响应对这些设备的安全性的更多真实世界数据的需求，SAFE-PAD 研究（紫杉醇涂层设备在股腘血管腔内治疗中的安全性评估）在食品和药物管理局的参与下设计，旨在对 Medicare 受益人群中与紫杉醇涂层设备相关的死亡率风险进行长期的、全面的评估。
SAFE-PAD 是一项观察性队列研究，纳入了 2015 年至 2018 年期间接受股腘动脉血运重建的 Medicare 按服务收费受益人群，使用药物涂层或非药物涂层设备。所有年龄在 66 岁及以上的接受血运重建的患者将通过手术代码、当前操作术语代码和医疗保健通用程序编码系统 C 代码的组合来识别。所有原因死亡的安全性终点将每半年更新一次，并持续到中位随访时间超过 5 年。将按设备类型、患者特征和手术环境进行亚组分析。注册：SAFE-PAD 研究已在 URL：https://www.clinicaltrials.gov 上注册；唯一标识符：NCT04496544。
SAFE-PAD 研究将评估在广泛的、真实世界的外周动脉疾病患者人群中，与非药物涂层设备相比，药物涂层设备用于股腘动脉血运重建的长期安全性。
