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 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.


BACKGROUND
ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02455661 ).
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany. christian.fastner@umm.de.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany. christian.fastner@umm.de.
Christian
C
Fastner
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Michael
M
Behnes
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Melike
M
Ünsal
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Ibrahim
I
El-Battrawy
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Uzair
U
Ansari
Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Kambis
K
Mashayekhi
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Ursula
U
Hoffmann
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Siegfried
S
Lang
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Jürgen
J
Kuschyk
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Martin
M
Borggrefe
First Department of Medicine, University Medical Center Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.|DZHK (German Center for Cardiovascular Research) partner site Mannheim, Mannheim, Germany.
Ibrahim
I
Akin
D000368:Aged; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D019106:Postoperative Hemorrhage / Q000628:therapy*; D011446:Prospective Studies; D017534:Radial Artery; D012307:Risk Factors; D016896:Treatment Outcome
Access site bleeding; FERARI; Femoral; PCI; Percutaneous coronary intervention; Radial; Vascular closure device