Early sheath removal after percutaneous coronary intervention using Assiut Femoral Compression Device is feasible and safe. Results of a randomized controlled trial

Abstract Objective This study was performed to evaluate the feasibility and safety of early sheath removal after percutaneous coronary intervention (PCI) using a locally designed Assiut Femoral Compression Device (AFCD2) vs. manual compression (MC). Background Due to antithrombotic therapy before, during, and after PCI, the arterial femoral sheath is generally not removed early after PCI. Patients and methods This was a randomized, controlled trial. We enrolled all patients undergoing PCI at Assiut University Hospitals from September, 2013 to December, 2013. At the end of PCI, the arterial hemostasis method was randomly assigned 1:1 to AFCD2 vs. MC. The sheaths were removed 2 h after PCI, instead of conventional 6 h, in the AFCD2 arm. Results The trial assigned 100 patients (mean age 57 ± 9 years, 75% men) to AFCD2 ( n  = 50) vs. MC ( n  = 50). Both groups were comparable regarding baseline characteristics. Concerning the primary effectiveness end point, there was significantly shorter mean time-to-ambulation with AFCD2 (8.2 ± 1.42 h) vs. MC (12.02 ± 0.22 h; p  =  p  =  Conclusion Our results indicate that AFCD2 is a simple and effective alternative to MC for hemostasis following PCI. Early sheath removal 2 h post PCI is feasible, safe, and improves the patient’s comfort.