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

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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).

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    Authors and Affiliations

    1. First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany

      Christian Fastner, Michael Behnes, Melike Ünsal, Ibrahim El-Battrawy, Uzair Ansari, Ursula Hoffmann, Siegfried Lang, Jürgen Kuschyk, Martin Borggrefe & Ibrahim Akin

    2. DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany

      Christian Fastner, Michael Behnes, Melike Ünsal, Ibrahim El-Battrawy, Uzair Ansari, Ursula Hoffmann, Siegfried Lang, Jürgen Kuschyk, Martin Borggrefe & Ibrahim Akin

    3. Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany

      Kambis Mashayekhi

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    1. Christian Fastner
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    Correspondence to Christian Fastner.

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    C. Fastner and M. Behnes contributed equally.

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    Fastner, C., Behnes, M., Ünsal, M. et al. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels 32, 520–530 (2017). https://doi.org/10.1007/s00380-016-0901-3

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