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首页> 外文期刊>Clinical Medicine Insights: Cardiology >Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study
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Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study

机译：与经皮冠状动脉介入治疗（FERARI）相关的股骨闭合与versus骨加压装置的设计和原理

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Background: Bleeding events after percutaneous coronary interventions (PCI) are associated with patients' age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes.Methods: The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band?) or femoral closure devices (Angio-Seal?) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up.Results: Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015.Conclusions: The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.
机译：背景：经皮冠状动脉介入治疗（PCI）后的出血事件与患者的年龄，性别，是否存在慢性肾脏疾病，抗血栓治疗以及动脉通路有关。使用radial骨入路部位接受PCI治疗的患者预后改善。然而，从未将股骨闭合装置的安全性与PCI后的径向压缩装置相比。因此，本研究的目的是评估经PCI介入治疗的患者中股骨闭合与compression骨加压装置相比的安全性，并考虑进入部位出血以及短期和长期的预后结果。与经皮冠状动脉介入治疗（FERARI）研究相关的是一项单中心观察性研究，比较了400例连续接受PCI手术的患者，这些患者在相应的进入部位使用了径向加压装置（TR Band？）或股骨闭合装置（Angio-Seal？）。主要结局包括在动脉通路部位发生血管并发症，包括常见分类系统定义的大出血。次要结果包括不良心脏事件的发生，包括全因死亡率，目标病变血运重建和随访中的30个月内的目标血管血运重建。结果：研究入组于2014年2月开始。结论：FERARI研究旨在比较评估在日常临床实践中接受PCI radial动脉或股动脉封闭装置治疗的患者的安全性和预后。

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