Comparison of the FemoStop device and manual pressure in reducing groin puncture site complications following coronary angioplasty and coronary stent placement.

This study compared two techniques, the FemoStop device (RADI Medical Systems, Uppsala, Sweden) and manual pressure, currently used by nurses to achieve haemostasis at the groin puncture site following removal of femoral arterial sheaths in patients following coronary angioplasty and coronary stent placement. Participants were randomly allocated the FemoStop device or manual pressure. Participants' groins were observed for evidence of complications including haemorrhage, haematoma formation and pseudoaneurysm following removal of the femoral arterial sheath and the following day. Of the 274 participants recruited into the study, 5.5% (n = 15) were unable to be included as a result of the absence of data on the Angioplasty Record of Care Form (n = 5) or excessive bleeding at the groin puncture site (n = 10). This left 259 eligible participants. Of these, 18.1% (n = 47) did not have their groin puncture site inspected by a post-procedural observer, thereby reducing the number of participants eligible to complete all stages of the study to 212. The results showed that the presence of a haematoma on removal of the femoral arterial sheath had a significant relationship with the type of treatment used, with those participants in the FemoStop device group showing a greater incidence of haematoma development at the time of sheath removal than those in the manual pressure group. No significant difference was detected in haematoma formation or bleeding between the two groups as a result of the risk factors identified in the literature, including participant anxiety, weight or anticoagulant therapy. There was not any significant difference between the two groups in reported pain during removal of the femoral arterial sheath; however, there was a significant distinction in the amount of time taken to achieve haemostasis. The results showed that haemostasis was achieved more quickly in those participants in the manual pressure group than those in the FemoStop group. The results of this research study indicate that although manual pressure achieved haemostasis more quickly than the FemoStop device, both methods are as effective in reducing groin complications in patients following removal of the femoral arterial sheath following coronary angioplasty and stent placement.

RCT Entities:   Population Interventions Outcomes