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Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary
Michael Behnes1, Melike Ünsal1, Ursula Hoffmann1
1First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
Insights
This study compares femoral closure devices to radial compression devices after percutaneous coronary interventions (PCI). It evaluates access site bleeding and patient outcomes to determine the safest arterial closure method post-PCI.
Area of Science:
- Cardiovascular Interventions
- Medical Device Safety
Background:
- Bleeding after percutaneous coronary interventions (PCI) is linked to patient factors and access site.
- Radial access sites in PCI are associated with better patient prognosis.
- Direct comparisons of femoral closure device safety versus radial compression devices after PCI are lacking.
Purpose of the Study:
- To compare the safety of femoral closure devices versus radial compression devices following PCI.
- To evaluate access site bleedings and short- and long-term prognostic outcomes in patients undergoing PCI.
Main Methods:
- The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study.
- It compares 400 patients undergoing PCI using either radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™).
- Primary outcome: vascular complications at the arterial access site. Secondary outcomes: adverse cardiac events, mortality, and revascularization at 30 days and 12 months.
Main Results:
- Enrollment began in February 2014 and was expected to conclude in May 2015.
Conclusions:
- The FERARI study aims to provide a comparative evaluation of safety and prognostic outcomes.
- It assesses radial versus femoral arterial closure devices in patients undergoing PCI in routine clinical practice.
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.
