Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs. the femostop device

Background: A number of haemostatic devices are available to facilitate ear ly haemostasis following transfemoral interventional procedures. Methods an d results: We have prospectively compared 150 patients (age: 57+/-12 years, mean+/-S.D.) who were randomly assigned to either external compression usi ng the FemoStop device or direct closure of the arterial puncture using the Angio-Seal device. The Angio-Seal was deployed in the catheter laboratory after the conclusion of the procedure. Patients, randomised to FemoStop, ha d their sheath removed when the activated clotting time (ACT) was less than 100 s before applying the device. The primary endpoint was the composite o f bleeding, haematoma formation, bruise, requirement for blood transfusion, clinical indication for ultrasound examination at 2 h and 24 h following t he procedure and crossover to either method at 2 and 24 h after the device deployment. The 95% of the Angio-Seal and 96% of FemoStop patients were dis charged on the day following the procedure. An increased number of patients in the Angio-Seal group reached a clinical end-point within the first 2 h (45% vs. 3%, P<0.0001). This difference became insignificant at 24 h (25% v s. 30%, P=0.6). Conclusion: Although less comfortable, the overall efficacy of the FemoStop appeared to be higher than that of the Angio-Seal device. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.