Vascular closure devices (VCD) are not inferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis in patients undergoing transfemoral coronary angiography, according to a study published in JAMA.
Patients with VCDs had shorter times to hemostasis than those with manual compression, and access site-related vascular complications were similar among the groups, Stefanie Schulz-Schüpke, MD, of the Deutsches Herzzentrum München, Technische Universität, in Munich, and colleagues reported.
The researchers recruited patients undergoing coronary angiography with a 6 French sheath via the common femoral artery at four centers in Germany from April 2011 through May 2014. After angiography, each patient was randomly assigned to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio.
The primary endpoint was the composite of access site-related vascular complications at 30 days after randomization with a 2% non-inferiority margin.
Out of the 4,524 total participants, 3,015 were assigned to the VCD group (1,509 in the intravascular group and 1,506 in the extravascular group) and 1,509 were in the manual compression group. The primary endpoint was seen in 6.9% of the VCD group and in 7.9% of the manual compression group.
Time to hemostasis was significantly shorter in patients with VCD compared with those with manual compression. Within the VCD groups, time to hemostasis was significantly shorter among patients with intravascular VCD compared with those with extravascular VCD.
The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial.
Study researcher Stefanie Schulz-Schüpke, MD, of the Deutsches Herzzentrum München, Technische Universität, in Munich, and colleagues compared outcomes with the use of two hemostasis strategies after diagnostic coronary angiography performed via transfemoral access — a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs. standard manual compression.
The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access–site complications.