A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty.
OBJECTIVE
to clarify the efficacy and safety of Prostar Plus, a new percutaneous vascular surgical device (PVS) for vascular haemostasis.


METHODS
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.
Noguchi
T
T
Division of Cardiology, National Cardiovascular Center, Osaka, Japan.
Miyazaki
S
S
Yasuda
S
S
Baba
T
T
Sumida
H
H
Morii
I
I
Daikoku
S
S
Goto
Y
Y
Nonogi
H
H
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D003327:Coronary Disease / Q000628:therapy*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery; D006488:Hemostasis, Surgical / Q000295:instrumentation* / Q000379:methods*; D017721:Hospital Costs; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome