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Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study
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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Libertas Academica
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4635979/ https://www.ncbi.nlm.nih.gov/pubmed/26568686 http://dx.doi.org/10.4137/CMC.S31932 |
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author | Behnes, Michael Ünsal, Melike Hoffmann, Ursula Fastner, Christian El-Battrawy, Ibrahim Lang, Siegfried Mashayekhi, Kambis Lehmann, Ralf Borggrefe, Martin Akin, Ibrahim |
author_facet | Behnes, Michael Ünsal, Melike Hoffmann, Ursula Fastner, Christian El-Battrawy, Ibrahim Lang, Siegfried Mashayekhi, Kambis Lehmann, Ralf Borggrefe, Martin Akin, Ibrahim |
author_sort | Behnes, Michael |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4635979 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Libertas Academica |
record_format | MEDLINE/PubMed |
spelling | pubmed-46359792015-11-13 Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study Behnes, Michael Ünsal, Melike Hoffmann, Ursula Fastner, Christian El-Battrawy, Ibrahim Lang, Siegfried Mashayekhi, Kambis Lehmann, Ralf Borggrefe, Martin Akin, Ibrahim Clin Med Insights Cardiol Methodology 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. Libertas Academica 2015-11-03 /pmc/articles/PMC4635979/ /pubmed/26568686 http://dx.doi.org/10.4137/CMC.S31932 Text en © 2015 the author(s), publisher and licensee Libertas Academica Ltd. This is an open access article published under the Creative Commons CC-BY-NC 3.0 license. |
spellingShingle | Methodology Behnes, Michael Ünsal, Melike Hoffmann, Ursula Fastner, Christian El-Battrawy, Ibrahim Lang, Siegfried Mashayekhi, Kambis Lehmann, Ralf Borggrefe, Martin Akin, Ibrahim Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study |
title | Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study |
title_full | Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study |
title_fullStr | Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study |
title_full_unstemmed | Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study |
title_short | Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study |
title_sort | design and rationale of the femoral closure versus radial compression devices related to percutaneous coronary interventions (ferari) study |
topic | Methodology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4635979/ https://www.ncbi.nlm.nih.gov/pubmed/26568686 http://dx.doi.org/10.4137/CMC.S31932 |
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