Vascular Closure Devices Noninferior to Manual Compression After PCI

By Will Boggs MD

November 20, 2014

NEW YORK (Reuters Health) - Vascular closure devices provide similar outcomes to manual compression for patients undergoing transfemoral coronary angiography, according to results from the ISAR-CLOSURE randomized clinical trial.

Studies have consistently shown that vascular closure devices (VCDs) shorten the time to hemostasis and ambulation, compared with manual compression, but several meta-analyses suggested they carry an increased risk of vascular complications.

Dr. Stefanie Schulz-Schuepke from Deutsches Herzzentrum Muenchen, Munich, Germany and colleagues in the randomized ISAR-CLOSURE trial assessed whether VCDs are noninferior to manual compression in 4524 patients undergoing diagnostic coronary angiography via transfemoral access.

Overall, 1509 received the intravascular FemoSeal VCD, 1506 received the extravascular Exoseal VCD, and 1509 received manual compression.

Time to hemostasis was significantly shorter with VCD vs manual compression (mean, 1 vs 10 minutes), but repeat manual compression was more frequent in the VCD group (1.8% vs 0.7%), the authors reported November 16th in JAMA, to coincide with a presentation at the American Heart Association meeting in Chicago.

Access site-related vascular complications were similarly frequent with VCD (208 patients, 6.9%) and manual compression (7.9%; p<0.001 for noninferiority; P=0.23 for superiority).

The incidence of hematoma was lower in patients assigned to VCD (4.8% vs 6.8%; p=0.006), but there was no difference between the groups in rates of pseudoaneurysm, arteriovenous fistula, or access site-related major bleeding.

In the comparison between VCDs, time to hemostasis was shorter and closure device failure was less common in the intravascular VCD group than in the extravascular VCD group.

Dr. Niels Ramsing Holm from Aarhus University Hospital in Denmark was the lead author on the CLOSE-UP study, which compared the FemoSeal VCD with manual compression. He told Reuters Health by email, "The main findings were in line with other studies on the investigated VCDs."

"One surprise was the balanced but high rate of pseudoaneurysms (1.5-2.1%) after both manual compression and VCDs when systematically assessed," Dr. Holm said. "This may be a factor in the present discussion of radial versus femoral access. Another interesting result was that the reduction in rate of major hematoma was driven by the FemoSeal VCD and thus confirmed that this is not a class effect of VCDs."

"The FemoSeal VCD may offer lower rate of large groin hematoma and shorter and more predictable closure procedures than both the Exoseal VCD and manual compression after coronary angiography," he concluded. "Whether or not the faster closure procedure outweighs the price of the VCD may depend on local facilities and staff level."

"Whether these results are applicable to patients undergoing elective and acute PCI merits dedicated well powered randomized trials," Dr. Holm added. "The major differences between (VCD) methods also call for longer term follow-up."

Dr. Holm disclosed that he has received "institutional research grants from Cordis and speaker fees and institutional research grants from St. Jude Medical."

Dr. Schulz-Schuepke did not respond to a request for comments.

SOURCE: http://bit.ly/11DmPyR

JAMA 2014;312:1981-1987.

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