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

Research output: Contribution to journalArticle

68 Citations (Scopus)

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).

Original languageEnglish (US)
Pages (from-to)785-793
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume2
Issue number8
DOIs
StatePublished - Aug 2009

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Thigh
Hemostasis
Walking
Confidence Intervals
Safety
Vascular Closure Devices
Multicenter Studies
Incidence

Keywords

  • arterial puncture
  • hemostasis
  • manual compression
  • percutaneous intervention
  • vascular closure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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). / Wong, S. Chiu; Bachinsky, William; Cambier, Patrick; Stoler, Robert; Aji, Janah; Rogers, Jason H; Hermiller, James; Nair, Ravi; Hutman, Herbert; Wang, Hong.

In: JACC: Cardiovascular Interventions, Vol. 2, No. 8, 08.2009, p. 785-793.

Research output: Contribution to journalArticle

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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).",
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T1 - 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)

AU - Wong, S. Chiu

AU - Bachinsky, William

AU - Cambier, Patrick

AU - Stoler, Robert

AU - Aji, Janah

AU - Rogers, Jason H

AU - Hermiller, James

AU - Nair, Ravi

AU - Hutman, Herbert

AU - Wang, Hong

PY - 2009/8

Y1 - 2009/8

N2 - 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).

AB - 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).

KW - arterial puncture

KW - hemostasis

KW - manual compression

KW - percutaneous intervention

KW - vascular closure

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