Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention

• Verfasst von: Fastner, Christian [VerfasserIn]
• Verfasst von: Behnes, Michael [VerfasserIn]
• Verfasst von: Tekinsoy, Melike [VerfasserIn]
• Verfasst von: El-Battrawy, Ibrahim [VerfasserIn]
• Verfasst von: Ansari, Uzair [VerfasserIn]
• Verfasst von: Hoffmann, Ursula [VerfasserIn]
• Verfasst von: Lang, Siegfried [VerfasserIn]
• Verfasst von: Kuschyk, Jürgen [VerfasserIn]
• Verfasst von: Borggrefe, Martin [VerfasserIn]
• Verfasst von: Akın, Ibrahim [VerfasserIn]
• Titel: Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention
• Titelzusatz: the FERARI study
• Verf.angabe: Christian Fastner, Michael Behnes, Melike Ünsal, Ibrahim El-Battrawy, Uzair Ansari, Kambis Mashayekhi, Ursula Hoffmann, Siegfried Lang, Jürgen Kuschyk, Martin Borggrefe, Ibrahim Akin
• E-Jahr: 2017
• Jahr: May 2017
• Umfang: 11 S.
• Fussnoten: First online: 01 November 2016 ; Gesehen am 12.11.2018
• Titel Quelle: Enthalten in: Heart and vessels
• Ort Quelle: Tokyo : Springer, 1985
• Jahr Quelle: 2017
• Band/Heft Quelle: 32(2017), 5, Seite 520-530
• ISSN Quelle: 1615-2573
• DOI: doi:10.1007/s00380-016-0901-3
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Access site bleeding
• Sach-SW: Aged
• Sach-SW: Equipment Design
• Sach-SW: Female
• Sach-SW: Femoral
• Sach-SW: Femoral Artery
• Sach-SW: FERARI
• Sach-SW: Hemostatic Techniques
• Sach-SW: Humans
• Sach-SW: Male
• Sach-SW: Middle Aged
• Sach-SW: Myocardial Ischemia
• Sach-SW: PCI
• Sach-SW: Percutaneous coronary intervention
• Sach-SW: Percutaneous Coronary Intervention
• Sach-SW: Postoperative Hemorrhage
• Sach-SW: Prospective Studies
• Sach-SW: Radial
• Sach-SW: Radial Artery
• Sach-SW: Risk Factors
• Sach-SW: Treatment Outcome
• Sach-SW: Vascular closure device
• K10plus-PPN: 1583612815

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 ).