A prospective randomized trial was conducted to evaluate the complication rate and patient comfort using three different vascular closure strategies following coronary angiography

Abstract

Background: The use of vascular closure devices is now common in clinical practice for femoral artery puncture, although manual compression remains the current gold standard. The development and use of vascular closure devices are aimed at improving patient comfort and avoiding complications such as hematoma, pseudoaneurysm formation, and the need for blood transfusion in the event of significant bleeding or surgical revision at the puncture site. Aims: The aim of this study is to evaluate the complication rate after femoral arterial puncture using different closure techniques. Furthermore, patient comfort will also be measured. Material and Methods: In this prospective, two-centre study, 142 patients were randomized into three groups: the Vascular Closure Device (VCD, Cordis), manual compression (MC) and External Compression Device (ECD, Maquet). The primary endpoint is combined with the evaluation of hematoma greater than 5 cm, pseudoaneurysm formation, the need for blood transfusion or relevant bleeding with a hemoglobin drop greater than 2 g/dl, the occurrence of retroperitoneal hematoma, pressure ulcers greater than grade 2, ischemia of the ipsilateral limb, or nerve damage. Follow-up visits are scheduled at 24 hours, 7 days, and 30 days. Results: The ratio of gender and pre-existing conditions within the randomized groups is almost equal. Medication before coronary angiography is comparable. Significantly more interventions are performed in the VCD group. Correspondingly, the procedure time is longer, and dual antiplatelet therapy is prescribed more often. Compression time and time to first hemostasis were significantly longer in the VCD group. The number of rebleeds after primary hemostasis is significantly higher in the ECD group. None of the enrolled patients suffered major bleeding or required a blood transfusion. No retroperitoneal hematoma was observed. Overall, there is one AV fistula in the MC group, two pseudoaneurysms in the VCD group, and one pseudoaneurysm in the ECD group. Pain was reported at significantly higher rates in the MC group than in either device group. The highest level of pain is reported within 48 hours in the MC group, and voiding dysfunction is significantly more frequent in the MC group. The same results are observed for sleep quality. Patients in the MC group reported significantly fewer hematomas greater than 5 cm at 7 days compared to patients who received a VCD. Conclusion: Our results show no significant difference in the achievement of the combined primary endpoint of all three groups. However, the rate of rebleeding after primary hemostasis is significantly lower in the VCD group, even with prolonged procedure time. There was no difference in the incidence of MACCE. Patient pain and voiding dysfunction within 24 hours are highest in the MC group. No difference is reported between 7 and 30 days.