Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial - ISAR-CLOSURE

Sep 13, 2014
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Deutsches Herzzentrum Muenchen
Date Presented:
01/01/2014
Date Updated:
09/13/2014
Original Posted Date:
09/13/2014
References

Description:

Although vascular closure devices (VCDs) are commonly used in patients undergoing transfemoral angiography, data on their efficacy are limited. The current trial sought to compare two different VCDs with manual compression in patients undergoing transfemoral diagnostic angiography.

Hypothesis:

VCDs are noninferior to manual compression for vascular access site complications.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients undergoing coronary angiography with a 6 French sheath via the common femoral artery

    Number of enrollees: 4,524
    Duration of follow-up: 30 days

Exclusions:

  • Previous implantation of a VCD
  • Prior thromboendarterectomy or patch plastic of the common femoral artery
  • Planned invasive procedure
  • Symptomatic leg ischemia
  • Heavily calcified vessel
  • Bleeding

Primary Endpoints:

  • Vascular access site complications (composite of hematoma ≥5 cm; arteriovenous fistula; pseudoaneurysm; access site–related bleeding; acute ipsilateral leg ischemia; need for vascular, surgical, or interventional treatment; or local infection) at 30 days

Secondary Endpoints:

  • Time to hemostasis
  • Repeat manual compression
  • VCD failure

Drug/Procedures Used:

Patients were randomized in a 1:1:1 ratio to Femoseal versus Exoseal versus manual compression.

Principal Findings:

A total of 4,524 patients were randomized, 1,509 to Femoseal, 1,506 to Exoseal, and 1,509 to manual compression. Baseline characteristics were fairly similar between the two arms.

The primary composite endpoint of vascular access site complications was noninferior in the composite VCD group versus manual compression (6.9% vs. 7.9%, p for noninferiority < 0.0001). The risk of pseudoaneurysm was numerically higher in the VCD arm. Time to hemostasis was lower in the VCD arm (1 vs. 10 minutes, p < 0.001). Repeat manual compression was, however, greater in the VCD arm (1.8% vs. 0.7%, p = 0.003). On direct comparison between Femoseal and Exoseal, the composite vascular endpoint was lower in the Femoseal arm (6.0% vs. 7.8%, p = 0.043). The risk of hematoma ≥5 cm was numerically lower (4.3% vs. 5.3%). Closure device failure was also lower (5.3% vs. 12.2%, p < 0.0001).

Interpretation:

The results of the ISAR-CLOSURE trial indicate that the use of VCDs is noninferior to manual compression for access site vascular complications in patients undergoing diagnostic angiography via common femoral arterial access. Time to hemostasis was lower with VCD use, but the risk of repeat manual compression, presumably due to VCD failure, was higher. Femoseal appeared to have a better profile than Exoseal. Since patients undergoing angioplasty and systemic anticoagulation were excluded from this trial, it is unknown if VCD use may have a beneficial effect in that patient population since they have a higher bleeding risk.

However, overall, the results of this trial are consistent with data from other randomized controlled trials, which suggest that VCD use is associated with faster ambulation compared with manual compression, but no improvement/reduction in vascular complication rates. Access site complication rates have declined significantly with transradial angiography compared with transfemoral angiography.

References:

Presented by Dr. Stefanie Schulz at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 13, 2014.

Keywords: Aneurysm, False, Hematoma, Hemostasis, Angioplasty, Hemorrhage, Equipment Failure, Transcatheter Cardiovascular Therapeutics


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