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Heart and Vessels

, Volume 32, Issue 5, pp 520–530 | Cite as

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

  • Christian Fastner
  • Michael Behnes
  • Melike Ünsal
  • Ibrahim El-Battrawy
  • Uzair Ansari
  • Kambis Mashayekhi
  • Ursula Hoffmann
  • Siegfried Lang
  • Jürgen Kuschyk
  • Martin Borggrefe
  • Ibrahim Akin
Original Article

Abstract

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).

Keywords

Femoral Percutaneous coronary intervention PCI Access site bleeding Radial  Vascular closure device FERARI 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that there is no conflict of interest.

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Copyright information

© Springer Japan 2016

Authors and Affiliations

  • Christian Fastner
    • 1
    • 2
  • Michael Behnes
    • 1
    • 2
  • Melike Ünsal
    • 1
    • 2
  • Ibrahim El-Battrawy
    • 1
    • 2
  • Uzair Ansari
    • 1
    • 2
  • Kambis Mashayekhi
    • 3
  • Ursula Hoffmann
    • 1
    • 2
  • Siegfried Lang
    • 1
    • 2
  • Jürgen Kuschyk
    • 1
    • 2
  • Martin Borggrefe
    • 1
    • 2
  • Ibrahim Akin
    • 1
    • 2
  1. 1.First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine MannheimUniversity of HeidelbergMannheimGermany
  2. 2.DZHK (German Center for Cardiovascular Research) partner site MannheimMannheimGermany
  3. 3.Division of Cardiology and Angiology IIUniversity Heart Center Freiburg-Bad KrozingenBad KrozingenGermany

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