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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| Main Authors: | , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
May 2017
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| In: |
Heart and vessels
Year: 2017, Volume: 32, Issue: 5, Pages: 520-530 |
| ISSN: | 1615-2573 |
| DOI: | 10.1007/s00380-016-0901-3 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1007/s00380-016-0901-3
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| Author Notes: | Christian Fastner, Michael Behnes, Melike Ünsal, Ibrahim El-Battrawy, Uzair Ansari, Kambis Mashayekhi, Ursula Hoffmann, Siegfried Lang, Jürgen Kuschyk, Martin Borggrefe, Ibrahim Akin |
| Summary: | 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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| Item Description: | First online: 01 November 2016 Gesehen am 12.11.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1615-2573 |
| DOI: | 10.1007/s00380-016-0901-3 |