ISAR-CLOSURE: Vascular closure devices noninferior to manual compression in transfemoral coronary angiography

WASHINGTON — In patients undergoing transfemoral coronary angiography, vascular closure devices were noninferior to manual compression for vascular access site complications and were associated with shorter time to hemostasis, according to findings presented at TCT 2014.

Researchers also compared vascular closure device types and found that the intravascular FemoSeal (St. Jude Medical) was associated with a trend toward fewer vascular access site complications, a shorter time to hemostasis and less frequent device failures compared with the extravascular ExoSeal (Cordis).

Stefanie Schüpke, MD, and colleagues conducted the randomized, open-label ISAR-CLOSURE trial of 4,524 patients undergoing diagnostic coronary angiography via the common femoral artery. Patients were randomly assigned on a 1:1:1 basis to the FemoSeal, the ExoSeal or manual compression. They also underwent duplex sonography before hospital discharge and clinical follow-up at 30 days.

“Although we have been using vascular closure devices for about 20 years in clinical practice, their role for the achievement of hemostasis after femoral artery puncture has remained quite controversial,” Schüpke, from Deutsches Herzzentrum München in Munich, said during a presentation. “Several meta-analyses have suggested an increased risk of vascular complications with vascular closure devices compared to manual compression.”

The primary endpoint was vascular access site complications at 30 days, defined as a composite of hematoma ≥5 cm, arterio-venous fistula, pseudoaneurysm, access–site-related bleeding, acute ipsilateral leg ischemia, need for vascular surgical or interventional treatment, and local infection. Secondary endpoints included time to hemostasis, repeat manual compression and vascular closure device failure.

There was no difference in the primary endpoint between patients who received a vascular closure device (6.9%) and those who received manual compression (7.9%; P=.227), Schüpke said. The majority of events were hematoma ≥5 cm, which occurred less frequently in those assigned to a vascular closure device (4.8%) vs. those assigned manual compression (6.8%; P=.006).

“Other, more severe events were more rare, and comparable between both groups,” she said.

Patients assigned a vascular closure device had a significantly reduced time to hemostasis compared with those assigned manual compression (1 minute vs. 10 minutes; P<.001), but were more likely to need repeat manual compression (1.8% vs. 0.7%; P=.003), Schüpke said.

Patients assigned the FemoSeal had a lower incidence of the primary endpoint compared with those assigned the ExoSeal (6% vs. 7.8%; P=.043), but the difference was not statistically significant because the significance level of the trial was P<.025, according to Schüpke.

However, the FemoSeal group had a shorter time to hemostasis (0.5 minutes vs. 2 minutes; P<.001) and a lower rate of device failure (5.3% vs. 12.2%; P<.001) compared with the ExoSeal group.

“The increase in efficacy with no trade-off in safety provides a sound rationale for the use of vascular closure devices over manual compression in the everyday routine,” Schüpke said.

For more information:

Schüpke S. Plenary Session V: First Reports #1. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.

Disclosure: Schüpke reports no relevant financial disclosures.