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= <0.001). This was directly reflected on shorter time for
hospital discharge eligibility in AFCD2 (11 ±1 h) vs. MC (15 ±1 h; p= <0.001). As regards
safety, none of our research population experienced major adverse events. The use of AFCD2
was associated with similar occurrence of minor complications, mainly ecchymosis and oozing,
compared with MC.