USEFULNESS OF COLLAGEN PLUGGING WITH VASOSEAL(R) AFTER PTCA AS COMPARED TO MANUAL COMPRESSION WITH IDENTICAL SHEATH DWELL TIMES

This study investigated the usefulness of collagen plugging with VasoS eal(R) in patients after PTCA compared to a control group having ident ical sheath dwell times and therefore comparable levels of anticoagula tion. A total of 150 patients were enrolled in this prospective and ra ndomized study. Sheaths were pulled at exactly 5 h after arterial punc ture. Time to hemostasis and local complications were determined. Ther e were no statistical differences in baseline characteristics. The mea n time to hemostasis in the collagen group was significantly shorter ( 3 +/- 3 min) than that of the control group (17.4 +/- 7 min). At 24 h, 23% of the collagen group patients had a small, 1% a medium and 4% a large hematoma. In the control group, 32% had a small, 4% a medium siz ed, but no patient a large hematoma, After collagen, one patient devel oped a pseudoaneurysm needing vascular surgery. In the control group, no major complication occurred. Compared to patients with manual compr ession at an identical sheath dwell time and an identical lever of ant icoagulation, there was a significant reduction in time to hemostasis but no statistical difference regarding local complications. Although the incidence of medium or large hematoma was low, the trend towards a decreased risk of smaller hematomas seemed to be counterbalanced by a n increased risk of larger hematomas. (C) 1998 Wiley-Liss, Inc.