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)

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 percutane-ous trans-femoral coronary or peripheral procedures.Background From a patient’s perspective, access site management after percutaneous proceduresremains challenging.Methods Patients enrolled in this multicenter, nonblinded trial underwent 6-F diagnostic or inter-ventional procedures were randomly assigned 2:1 to VCD versus MC. The primary efficacy endpoints were time to hemostasis (TTH) and time to ambulation (TTA), and the primary safety endpoints 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 char-acteristics of the groups were similar. Procedural success was 91.8% in the VCD versus 91.0% in the MCgroup (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). Nopatient died or suffered a major access-site-related adverse event. Minor adverse events were few amongall study groups.Conclusions After 6-F percutaneous invasive procedures, TTH and TTA were both significantlyshorter 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 theEnsure Medical Vascular Closure Device; NCT00345631) (J Am Coll Cardiol Intv 2009;2:785–93)© 2009 by the American College of Cardiology Foundation