Key result
Femoral closure devices were associated with a higher rate of access-site bleeding compared to radial compression devices following percutaneous coronary intervention.
Why the study?
Bleeding is a major complication after PCI, and directly comparing specific femoral closure and radial compression devices for bleeding and MACE was needed.
Does a radial compression device reduce bleeding complications compared to a femoral closure device in patients undergoing percutaneous coronary intervention?
Observational (n=400)
Open-label
Non-randomized
No
Does a radial compression device reduce bleeding complications compared to a femoral closure device in patients undergoing percutaneous coronary intervention?
Trans-radial access with a radial compression device is associated with significantly lower access-site bleeding compared to trans-femoral access with a femoral closure device, without differences in 30-day MACE.
Answers are grounded in this paper and cite their sources.
Radial compression devices were associated with less bleeding than femoral closure after PCI; leaves open need for randomized confirmation before practice change.
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.
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Kim et al. (2019) conducted an observational in Percutaneous coronary intervention (PCI) (n=400). Femoral closure device (StarClose SE) vs. Radial compression device (TR Band) was evaluated on Access-site bleeding (p=0.001). Femoral closure devices were associated with a higher rate of access-site bleeding compared to radial compression devices following percutaneous coronary intervention.
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