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Differences of bleedings after percutaneous coronary intervention using femoral closure and radial compression
Seung-Hyun Kim1, Michael Behnes1, Sebastian Baron1
1First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Center for AngioScience (ECAS), and DZHK (German Center for Cardiovascular Research) partner site Heidelberg/Mannheim, Mannheim, Germany.
Insights
Femoral closure devices show higher bleeding rates after percutaneous coronary intervention compared to radial compression. Major adverse cardiac events remained similar between groups, suggesting radial access may reduce bleeding complications.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Access Management
Background:
- Bleeding complications are a major concern following percutaneous coronary intervention (PCI).
- Vascular closure devices (VCDs) are utilized to mitigate bleeding risks and improve patient outcomes.
- Comparing specific femoral closure (FC) and radial compression (RC) devices is crucial for optimizing procedural safety.
Purpose of the Study:
- To directly compare the efficacy and safety of a specific femoral closure (StarClose SE) versus a radial compression (TR Band) device post-PCI.
- To evaluate differences in overall and access-site bleeding rates.
- To assess major adverse cardiac events (MACE) at 30-day follow-up.
Main Methods:
- A single-center, prospective, observational study enrolled 200 patients in each group (FC vs. RC) after PCI.
- The primary outcome was bleeding complications.
- Secondary outcomes included MACE at 30 days.
Main Results:
- Access-site bleeding was significantly higher in the FC group (43%) compared to the RC group (30%) (P=.001).
- Hematomas, including small and large sizes, were more frequent in the FC group.
- No significant differences in MACE were observed between the FC and RC groups.
Conclusions:
- Transfemoral arterial access, even with VCDs, is associated with higher access-site bleeding rates, primarily hematomas, compared to trans-radial access.
- No significant difference in MACE was found between femoral closure and radial compression groups at 30-day follow-up.
Abstract:
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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