A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). Academic Article uri icon

Overview

abstract

  • OBJECTIVES: This trial compared the performance of a novel bioabsorbable vascular closure device (VCD) versus manual compression (MC) for access site hemostasis in patients undergoing percutaneous trans-femoral coronary or peripheral procedures. BACKGROUND: From a patient's perspective, access site management after percutaneous procedures remains challenging. METHODS: Patients enrolled in this multicenter, nonblinded trial underwent 6-F diagnostic or interventional procedures were randomly assigned 2:1 to VCD versus MC. The primary efficacy end points were time to hemostasis (TTH) and time to ambulation (TTA), and the primary safety end points were periprocedural and 30-day incidence of arterial access-related complications. RESULTS: The trial assigned 401 patients (mean age 62.7 +/- 10.9 years, 66.1% men) to VCD (n = 267) versus MC (n = 134) after 87 "roll-in" patients treated at 17 participating institutions. The baseline characteristics of the groups were similar. Procedural success was 91.8% in the VCD versus 91.0% in the MC group (p = NS). Mean TTH was 4.4 +/- 11.6 min in the VCD versus 20.1 +/- 22.5 min in the MC group (95% confidence interval: 19.0 to 12.3; p < 0.0001). Likewise, TTA was significantly shorter in the VCD (2.5 +/- 5.0 h) than in the MC (6.2 +/- 13.3 h) group (95% confidence interval: 5.5 to 1.9; p = 0.0028). No patient died or suffered a major access-site-related adverse event. Minor adverse events were few among all study groups. CONCLUSIONS: After 6-F percutaneous invasive procedures, TTH and TTA were both significantly shorter in patients assigned to VCD than in patients managed with MC. The 30-day rates of access-site-related complications were remarkably low in all groups. (Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device; NCT00345631).

authors

  • Wong, Shing Chiu
  • Bachinsky, William
  • Cambier, Patrick
  • Stoler, Robert
  • Aji, Janah
  • Rogers, Jason H
  • Hermiller, James
  • Nair, Ravi
  • Hutman, Herbert
  • Wang, Hong

publication date

  • August 1, 2009

Research

keywords

  • Absorbable Implants
  • Cardiac Catheterization
  • Catheterization, Peripheral
  • Femoral Artery
  • Hemorrhage
  • Hemostasis
  • Hemostatic Techniques

Identity

Scopus Document Identifier

  • 68749086042

Digital Object Identifier (DOI)

  • 10.1016/j.jcin.2009.06.006

PubMed ID

  • 19695549

Additional Document Info

volume

  • 2

issue

  • 8