A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty
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T Noguchi1, S Miyazaki, S Yasuda
1Division of Cardiology, National Cardiovascular Center, Osaka, Japan.
Objectives:
to clarify the efficacy and safety of Prostar Plus, a new percutaneous 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 angioplasty 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 increased patient comfort assessed by using a visual-analogue scale method. Although these clinical benefits reduced the hospital cost ($1301 s. d. 248 vs. 1613 s.d. 460, p <0.05), the cost of the PVS device (approximately $350) cancelled the cost-saving benefit.
Conclusions:
this randomised study indicates that Prostar Plus is safe, more effective and comfortable than conventional manual compression.
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