Bleedings represent most relevant complications being correlated with significant rates of adverse clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). To reduce bleeding and improve prognosis various types of vascular closure devices (VCD) are frequently applied. This study aims to compare directly one specific femoral closure (FC) to one specific radial compression (RC) device in patients after PCI focusing on overall and access-site bleedings as well as major adverse cardiac events (MACE). This single-center, prospective, and observational study included consecutive patients either treated by the FC (StarClose SE) or RC (TR Band) device following PCI. The primary outcome was bleeding; the secondary outcomes were MACE at 30 days of follow-up. Two hundred patients in each group were enrolled following PCI. Access-site bleeding was significantly higher in the FC (43%) compared to the RC (30%) group ( P = .001). Most common type of access-site bleeding consisted of hematomas. Of these, small and large hematomas were significantly higher in the FC group ( P < .05). No significant differences of MACE were observed in both groups. In multivariable logistic regression models no consistent significant association of any risk factor with bleeding complications was identified. Despite the use of VCD, transfemoral arterial access is still associated with a higher rates of access site bleeding consisting mostly of hematomas compared to trans-radial access, whereas no differences of MACE were observed between FC and RC patients at 30 days follow-up.

Background: Various types of vascular closure devices (VCDs) are frequently utilized in patients undergoing percutaneous coronary intervention (PCI) in order to prevent arterial access site bleeding, which represents one of the most relevant complications associated with adverse clinical outcomes. This study aims to compare directly two mechanistically different types of femoral closure (FC) devices in patients undergoing PCI.Methods: This single-center, prospective, observational study includes consecutively patients either treated by the extravascular StarClose SE® (Abbott, Illinois, U.S.A.) or the intravascular AngioSeal™ FC (St. Jude Medical, Inc., St. Paul, MN, U.S.A.) after PCI. The primary endpoint was bleeding complications, the secondary endpoint was major adverse cardiac events (MACE) at 30 days of follow-up.Results: 200 patients in each group (StarClose SE® and AngioSeal™) were enrolled following PCI. The rates of overall and non-access site bleedings were significantly higher in the AngioSeal™ group (56%; 6%) compared to the StarClose SE® group (43.5%; 0.5%) (p = 0.012; 0.003). Additionally, complicated access site bleedings were also significantly higher in the AngioSeal™ group (p = 0.011). No significant differences of MACE were observed in both groups. However, there was a higher rate of unsuccessful implantation of the StarClose SE® (n=12, excluded from the study).Conclusions: In case of successful implantation, FC by the AngioSeal™ is associated with the higher rate of both access and non-access site bleedings, but similar rates of MACE at 30 days compared to the StarClose SE® device.