Reducing bedrest following arterial puncture for coronary interventional procedures--impact on vascular complications: the BAC Trial.

BACKGROUND

The optimal time for ambulating patients following femoral arterial puncture for percutaneous coronary intervention is unknown. This study was designed to test the hypothesis that reducing time to ambulation from 6 hours to 2 hours would not increase vascular complications.

METHODS

In this randomized, controlled, single-center trial, patients were randomly assigned to receive either 2, 4 or 6 hours (control group) of bedrest after hemostasis was achieved at the femoral arterial puncture site. A total of 354 patients, enrolled from March 1997 to October 1998, participated in the study with 299 completing the full protocol. The primary endpoint was the incidence of vascular complications and any resulting interventions or outcomes including surgery, blood transfusion, prolonged length of stay or ultrasound compression.

RESULTS

The 2 hour and 4 hour experimental groups were comprised of 99 patients each, while the 6 hour control group was comprised of 101 patients. There were no differences in vascular complications between the groups. A subgroup analysis of patients who received abciximab (n = 43) did not reveal any differences between groups. Only one patient developed a pseudoaneurysm (p = 0.36), requiring surgical repair and a prolonged length of stay.

CONCLUSIONS

Patients undergoing femoral arterial puncture for coronary interventional procedures can safely ambulate 2 hours after hemostasis of the puncture site. Patients receiving abciximab as part of their coronary procedure may be able to ambulate as early as 2 hours following hemostasis.