Results of ISAR-CLOSURE Trial Reported at TCT 2014

WASHINGTON, DC – September 13, 2014 – A new clinical trial found that vascular closure devices (VCD) are non-inferior to manual compression in patients undergoing transfemoral coronary angiography. Findings were reported today at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Vascular closure devices help achieve more rapid hemostasis after coronary angiography, however the safety and efficacy of these devices compared to standard manual compression remains controversial. Some meta-analyses have suggested an increased risk of vascular complications with VCD compared with manual compression, while other studies have demonstrated a reduction in bleeding complications with VCD.

The ISAR-CLOSURE trial compared outcomes after arteriotomy closure with two different vascular closure devices with manual compression after diagnostic angiography performed through the femoral access route. The multicenter, open-label clinical trial randomized 4,524 patients undergoing diagnostic coronary angiography via the common femoral artery to receive either manual compression (n=1,509) or one of two vascular closure devices (Femoseal VCD n=1,509; Exoseal VCD n= 1,506).

The primary endpoint was vascular access site complications including the composite of hematoma greater than or equal to five centimeters, arterio-venous fistula, pseudoaneurysma, access-site related bleeding, acute ipsilateral leg ischemia, the need for vascular surgical or interventional treatment, and local infection at 30 days after randomization. Secondary endpoints included time to hemostasis, repeat manual compression and device failure. A secondary comparison between the two VCDs was also performed.

After 30 days, the VCD group reported access site complications in 6.9 percent of patients compared to 7.9 percent in the manual compression group, establishing non-inferiority of VCD. The most common complication in both groups was hematoma formation, followed by pseudoaneurym formation. Time to hemostasis was shorter in the VCD group (median 1 minute [.5-2.0] vs. 10 minutes [10-15], p<0.001), while the VCD group had a higher rate of repeat manual compressions (1.8 percent vs. 0.7 percent, p=0.003).

The secondary comparison found that the intravascular Femoseal VCD was associated with a tendency towards less vascular access-site complications as compared to the extravascular Exoseal VCD (6.0 percent vs. 7.8 percent, p=0.043). (Due to multiple comparisons, a p-value of 0.025 was considered statistically significant.) In addition, time-to-hemostasis was shorter and device deployment failures were less frequent with the Femoseal VCD compared to the Exoseal VCD.

“In patients undergoing transfemoral coronary angiography, VCDs are non-inferior to manual compression in terms of vascular access site complications and reduced time-to-hemostasis,” said lead investigator Stefanie Schulz, MD from Deutsches Herzzentrum München in Germany.

“The increase in efficacy of VCD with no trade-off in safety provides a sound rationale for the use of VCD over manual compression in daily routine.” 

The ISAR-CLOSURE trial received no extramural funding. Dr. Schulz reported no disclosures.

 

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