Author + information
- Received March 10, 2009
- Accepted June 11, 2009
- Published online August 1, 2009.
- S. Chiu Wong, MD⁎,⁎ (, )
- William Bachinsky, MD†,
- Patrick Cambier, MD‡,
- Robert Stoler, MD§,
- Janah Aji, MD∥,
- Jason H. Rogers, MD¶,
- James Hermiller, MD#,
- Ravi Nair, MD⁎⁎,
- Herbert Hutman, MD††,
- Hong Wang, MD, MPH††,
- ECLIPSE Trial Investigators
- ↵⁎Reprint requests and correspondence:
Dr. S. Chiu Wong, New York Presbyterian Hospital, 525E 68th Street, F433 Box 108, New York, New York 10065
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)
This study was sponsored by Cordis Corporation, a Johnson & Johnson company. Drs. Hutman and Wang are full-time employees of Cordis, JNJ. Drs. Wong, Bachinsky, and Nair, and Jason Rogers have consulting agreements with Cordis, JNJ.
- Received March 10, 2009.
- Accepted June 11, 2009.
- American College of Cardiology Foundation