Ambulation after femoral sheath removal in percutaneous coronary intervention: a prospective comparison of early vs. late ambulation

To investigate if ambulation four hours after sheath removal can replace ambulation 10 hours or more after sheath removal with regard to puncture site complications after percutaneous coronary interventions and to examine patient comfort in both groups. Early ambulation after percutaneous coronary intervention may facilitate earlier hospital discharge. Whether this approach is safe, is unknown. A non-randomised comparative study. Percutaneous coronary intervention was performed by femoral approach. Registered nurses of the ward removed the sheath and haemostasis was achieved by manual compression. After bed rest with a compression bandage for four hours, the patients in the early ambulation group were ambulated. The patients in the control group stayed in bed till the next morning. Primary study endpoint was the composition of puncture site complications: haematoma, bleeding, false aneurysm and arteriovenous fistula. Secondary endpoints were occurrence of vasovagal collapse after mobilisation, back pain and problems with voiding. In the early ambulation group (n = 329) the total number of complications was nine (2.7%), vs. six (3.0%) in the control group (n = 202). The complication rate in the early ambulation group is not increased compared to the control group (test for non-inferiority p = 0.002). Hence non-inferiority is accepted and practical equivalence shown. There were no statistically significant differences concerning patient comfort between the groups. Early ambulation four hours after femoral sheath removal is feasible and safe. The incidence of puncture site complications in the early ambulation group is not increased in comparison with the group with prolonged bed rest. Patients could possibly be discharged earlier after percutaneous coronary intervention, allowing percutaneous coronary intervention in an ambulant setting. Further research should confirm these findings and extend the research to the effect of various closure devices in early ambulation and on patients' well-being.