Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• The efficacy of vascular closure devices (VCD) for hemostasis following transfemoral coronary angiography is debated.
• Transfemoral access is common for coronary angiography, necessitating effective hemostasis strategies.

Purpose of the Study:

• To compare the safety and efficacy of VCD-based hemostasis versus manual compression after diagnostic coronary angiography.
• To evaluate the noninferiority of VCDs regarding vascular access-site complications.
• To compare the performance of intravascular and extravascular VCDs.

Main Methods:

• A large-scale, multicenter, randomized, open-label clinical trial involving 4524 patients undergoing coronary angiography via 6 French sheath transfemoral access.
• Patients were randomized to receive hemostasis via intravascular VCD, extravascular VCD, or manual compression (1:1:1 ratio).
• The primary endpoint was a composite of access site-related vascular complications at 30 days, with a 2% noninferiority margin.

Main Results:

• Vascular closure devices (VCD) were noninferior to manual compression, with 6.9% complications versus 7.9% (P for noninferiority < .001).
• Time to hemostasis was significantly shorter with VCD (1 minute) compared to manual compression (10 minutes) (P < .001).
• Intravascular VCDs achieved faster hemostasis (0.5 minutes) and had lower failure rates (5.3%) than extravascular VCDs (2.0 minutes, 12.2%; P < .001).

Conclusions:

• Vascular closure devices (VCD) are a safe and effective alternative to manual compression for achieving hemostasis after transfemoral coronary angiography.
• VCDs significantly reduce the time required for hemostasis.
• Intravascular VCDs demonstrate superior performance over extravascular VCDs in terms of speed and reliability.