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.


TRIAL REGISTRY
ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02455661 ).
['Fastner|Christian|C|', 'Behnes|Michael|M|', 'Ünsal|Melike|M|', 'El-Battrawy|Ibrahim|I|', 'Ansari|Uzair|U|', 'Mashayekhi|Kambis|K|', 'Hoffmann|Ursula|U|', 'Lang|Siegfried|S|', 'Kuschyk|Jürgen|J|', 'Borggrefe|Martin|M|', 'Akin|Ibrahim|I|']
D000368:Aged D004867:Equipment Design D005260:Female D005263:Femoral Artery D006489:Hemostatic Techniques D006801:Humans D008297:Male D008875:Middle Aged D017202:Myocardial Ischemia D062645:Percutaneous Coronary Intervention D019106:Postoperative Hemorrhage D011446:Prospective Studies D017534:Radial Artery D012307:Risk Factors D016896:Treatment Outcome
Femoral Radial Percutaneous coronary intervention FERARI PCI Access site bleeding Vascular closure device