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

Eur J Vasc Endovasc Surg. 2000 May;19(5):451-5. doi: 10.1053/ejvs.1999.1071.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Angioplasty, Balloon, Coronary* / adverse effects
  • Coronary Disease / therapy*
  • Equipment Design
  • Equipment Safety
  • Female
  • Femoral Artery
  • Hemostasis, Surgical / instrumentation*
  • Hemostasis, Surgical / methods*
  • Hospital Costs
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / prevention & control*
  • Prospective Studies
  • Treatment Outcome