TY - JOUR
T1 - A randomised controlled trial of Prostar Plus(TM) for haemostasis in patients after coronary angioplasty
AU - Noguchi, T.
AU - Miyazaki, S.
AU - Yasuda, S.
AU - Baba, T.
AU - Sumida, H.
AU - Morii, I.
AU - Daikoku, S.
AU - Goto, Y.
AU - Nonogi, H.
PY - 2000/5
Y1 - 2000/5
N2 - Objectives: to clarify the efficacy and safety of Prostar Plus(TM), 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 (~ $350) cancelled the cost-saving benefit. Conclusions: this randomised study indicates that Prostar Plus(TM) is safe, more effective and comfortable than conventional manual compression.
AB - Objectives: to clarify the efficacy and safety of Prostar Plus(TM), 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 (~ $350) cancelled the cost-saving benefit. Conclusions: this randomised study indicates that Prostar Plus(TM) is safe, more effective and comfortable than conventional manual compression.
KW - Angioplasty
KW - Catheterisation
KW - Complications
KW - Percutaneous vascular surgical device
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U2 - 10.1053/ejvs.1999.1071
DO - 10.1053/ejvs.1999.1071
M3 - Article
C2 - 10828223
AN - SCOPUS:0034193750
SN - 1078-5884
VL - 19
SP - 451
EP - 455
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
IS - 5
ER -