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Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study

This study aims to compare prospectively the differences of clinical outcomes being associated with a specific femoral closure (FC) compared to a radial compression (RC) device following percutaneous coronary interventions (PCI). This single-center, prospective observational study included consecuti...

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Hauptverfasser: Fastner, Christian (VerfasserIn) , Behnes, Michael (VerfasserIn) , Tekinsoy, Melike (VerfasserIn) , El-Battrawy, Ibrahim (VerfasserIn) , Ansari, Uzair (VerfasserIn) , Hoffmann, Ursula (VerfasserIn) , Lang, Siegfried (VerfasserIn) , Kuschyk, Jürgen (VerfasserIn) , Borggrefe, Martin (VerfasserIn) , Akın, Ibrahim (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: May 2017
In: Heart and vessels
Year: 2017, Jahrgang: 32, Heft: 5, Pages: 520-530
ISSN:1615-2573
DOI:10.1007/s00380-016-0901-3
Online-Zugang:Verlag, Volltext: http://dx.doi.org/10.1007/s00380-016-0901-3
Volltext
Verfasserangaben:Christian Fastner, Michael Behnes, Melike Ünsal, Ibrahim El-Battrawy, Uzair Ansari, Kambis Mashayekhi, Ursula Hoffmann, Siegfried Lang, Jürgen Kuschyk, Martin Borggrefe, Ibrahim Akin
Beschreibung
Zusammenfassung:This study aims to compare prospectively the differences of clinical outcomes being associated with a specific femoral closure (FC) compared to a radial compression (RC) device following percutaneous coronary interventions (PCI). This single-center, prospective observational study included consecutively 400 patients either treated by a specific FC (Angio-Seal™, St. Jude Medical, Inc., St. Paul, MN) or RC (TR Band®, Terumo Corporation, Tokyo, Japan) device following PCI. The primary outcome was to evaluate overall, access site and non-access site bleedings, the secondary outcome was major adverse cardiac events (MACE) occurring within 30 days of follow-up. 200 patients in each group (FC and RC group) were enrolled following PCI. The prevalence of overall bleedings was 56% in FC and 37% in RC group (p = 0.001). Access site bleedings were significantly higher in the FC (50%) compared to the RC (30%) group (p = 0.001). Most common type of access site bleeding consisted of hematomas (FC 45% vs. RC 27%, p = 0.001). Of these, intermediate and large hematomas were significantly higher in the FC group (p < 0.05). Surgical interventions following device-related bleedings were uncommon in both groups. No significant differences of MACE were observed in both treatment groups. Despite the use of a vascular closure device, the femoral arterial access is still associated with a higher rate of access site bleedings, consisting mostly of intermediate to large hematomas. No differences of MACE were found between FC versus RC following PCI at 30 days. TRIAL REGISTRY: ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02455661 ).
Beschreibung:First online: 01 November 2016
Gesehen am 12.11.2018
Beschreibung:Online Resource
ISSN:1615-2573
DOI:10.1007/s00380-016-0901-3

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