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

T. Noguchi, S. Miyazaki, S. Yasuda, T. Baba, H. Sumida, I. Morii, S. Daikoku, Y. Goto, H. Nonogi

Research output: Contribution to journalArticlepeer-review

40 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)451-455
Number of pages5
JournalEuropean Journal of Vascular and Endovascular Surgery
Issue number5
Publication statusPublished - 2000 May
Externally publishedYes


  • Angioplasty
  • Catheterisation
  • Complications
  • Percutaneous vascular surgical device

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine


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