A randomised controlled trial of Prostar Plus (TM) for haemostasis in patients after coronary angioplasty

Objectives: to clarify the efficacy and safety of Prostar Plus(TM), a new p ercutaneous vascular surgical device (PVS) for vascular haemostasis. Design: prospective randomised controlled trial. Methods: a consecutive series of 60 patients were randomised to either PVS (n = 30) or conventional manual compression (n = 30) following coronary ang ioplasty or stenting with femoral access using an 8-F sheath. Results: PVS significantly shortened the time to haemostasis (10 S.D. 3 vs. 27 S.D. 9 min, p<0.001), ambulation (2.2 S.D. 0.9 vs. 11.0 S.D. 1.4 h, p<0 .001), and discharge (2.2 S.D. 0.4 vs. 3.1 S.D. 0.7 days, p<0.01), compared with the manual compression group with no major complications. PVS also in creased patient comfort assessed by using a visual-analogue scale method. A lthough these clinical benefits reduced the hospital cost ($1301 S.D. 248 v s. 1613 S.D. 460, p<0.05), the cost of the PVS device (similar to$350) canc elled the cost-saving benefit. Conclusions: this randomised study indicates that Prostar Plus(TM) is safe, more effective and comfortable than conventional manual compression.