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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)

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 for the ECLIPSE Trial Investigators

^_* Weill Medical College of Cornell University, New York, New York
Pinnacle Health at Harrisburg, Harrisburg, Pennsylvania
Morton Plant Hospital, Clearwater, Florida
Baylor Research Institute, Dallas, Texas
^|| Cooper Health Systems, Camden, New Jersey
^¶ University of California, Davis Medical Center, Sacramento, California
^# The Heart Center of Indiana, Indianapolis, Indiana
^_** University Hospitals of Cleveland, Cleveland, Ohio
Cordis Corporation, Warren, New Jersey

^_* Reprint requests and correspondence: Dr. S. Chiu Wong, New York Presbyterian Hospital, 525E 68th Street, F433 Box 108, New York, New York 10065 (Email: scwong{at}med.cornell.edu).

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)

Key Words: hemostasis • vascular closure • manual compression • percutaneous intervention • arterial puncture

Abbreviations and Acronyms   CI = confidence interval   MAE = major adverse event   MC = manual compression   TTA = time to ambulation   TTH = time to hemostasis   VCD = vascular closure device