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).
OBJECTIVE
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).
Wong
S Chiu
SC
Weill Medical College of Cornell University, New York, New York, USA. scwong@med.cornell.edu
Bachinsky
William
W
Cambier
Patrick
P
Stoler
Robert
R
Aji
Janah
J
Rogers
Jason H
JH
Hermiller
James
J
Nair
Ravi
R
Hutman
Herbert
H
Wang
Hong
H
D020341:Absorbable Implants; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects*; D002406:Catheterization, Peripheral / Q000009:adverse effects*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D006487:Hemostasis; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D011677:Punctures; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D014481:United States