Comparison of Exo-Seal(®) and Angio-Seal (®) for arterial puncture site closure: A randomized, multicenter, single-blind trial.

ABSTRACT

BACKGROUND: The use of extravascular femoral closure devices in patients undergoing coronary angiography/intervention has not been sufficiently evaluated. We sought to define the impact of an extravascular polyglycolic acid (PGA) plug for the closure of a femoral access site in patients undergoing coronary angiography and/or percutaneous coronary intervention. METHODS: In this prospective, single-blind, multicenter trial we randomly assigned 319 patients to vessel closure with Angio-Seal(®) or Exo-Seal(®). We hypothesized that the use of an extravascular closure device is not inferior to an anchor/plug-mediated device regarding the occurrence of the composite primary endpoint hematoma > 5 cm, significant groin bleeding (TIMI major bleed), false aneurysm, and device failure. RESULTS: There was no significant difference in patient baseline characteristics or procedural results. After 24 h the primary endpoint occurred in nine patients (5.6 %) in the Angio-Seal(®) group and in 13 patients (8.2 %) inthe Exo-Seal(®) group (p = 0.38). Hematoma > 5 cm was noted in three patients (1.9 %) receiving Angio-Seal(®) vs. two patients (1.3 %) receiving Exo-Seal(®) (p = 0.99). In one patient (0.6 %) of the Exo-Seal(®) group, TIMI major bleeding occurred, requiring transfusion (p = 0.49). There were four (2.5 %) false aneurysms found in patients treated with Angio-Seal(®) and two (1.3 %) in patients treated with Exo-Seal(®) (p = 0.68). There was a trend for a higher incidence of device failure in the Exo-Seal(®) group (1.2 vs. 5.2 %, p = 0.06). At telephone interview after 30 days, there was no significant difference found regarding the events readmission with surgery of puncture site, infection, bleeding, hematoma, or pain. CONCLUSION: In the present study, there were no significant differences found regarding the occurrence of hematoma > 5 cm, major bleeding, false aneurysm, and device failure between Angio-Seal(®) and Exo-Seal(®) 24 h after device implantation.