Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the suture to ambulate and discharge (STAND I and STAND II) trials

Despite advances in other aspects of cardiac catheterization, manual or mec hanical compression followed by 4 to 8 hours of bed rest remains the mainst ay of postprocedural femoral access site management. Suture-mediated closur e may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial [STAND I) evaluated the 6Fr Tech star device in 200 patients undergoing diagnostic procedures, with successf ul hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 51 5 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS), M ajor complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05), Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significant ly shorter for suture-mediated closure, Suture-mediated closure of the arte rial puncture site thus affords reliable immediate hemostasis and shortens the rime to ambulation without significantly increasing the risk of local c omplications. (C)2000 by Excerpta Medico, Inc.