A SINGLE-CENTER RANDOMIZED TRIAL ASSESSING USE OF A VASCULAR HEMOSTASIS DEVICE VS CONVENTIONAL MANUAL COMPRESSION FOLLOWING PTCA - WHAT ARE THE POTENTIAL RESOURCE SAVINGS

We undertook a randomized controlled trial comparison VasoSeal(TM), a collagen vascular hemostasis device (VHD), with manual compression to assess its role and potential cost savings in the PTCA population. Of 460 patients, 359 were excluded due to clinical instability (30%), groin problems (18%), suboptimal PTCA result (15%), and other reasons (37%). The remaining 101 patients were randomized to either VHD (51) or manual compression (50). Hemostasis time, time to ambulation, duration of hospital stay, and nursing time and intensity were significantly reduced in the VHD group. There were no major groin complications in either treatment arm but there was a trend toward more minor groin complications in the VHD patients. The application of VasoSeal(TM) reduced resource use in this randomized study and may translate into significant cost reductions in the general coronary angioplasty population. (C) 1995 Wiley-Liss, Inc.