Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device.

OBJECTIVES: This study is the first head-to-head analysis of StarClose vs. ProGlide in patients undergoing 5F or 6F percutaneous coronary catheterization or peripheral artery interventions.

BACKGROUND: The clip based StarClose and the suture mediated ProGlide vascular closure device are well established for femoral hemostasis in endovascular therapy. However, until now no prospective randomized study compared the safety and efficacy of the two devices.

METHODS: This prospective, randomized, single-center study enrolled 505 patients (69.6 ± 11.2 years) resulting in 538 procedures due to more than one intervention in several patients: We analyzed 422 cardiac catheterization and 116 peripheral artery interventions via a common femoral artery access. Patients were randomized to StarClose or ProGlide (1:1). In-hospital complications (major bleeding, hematoma, pseudoaneurysm, vessel occlusion, and arteriovenous fistula) and device failure were recorded. The puncture site was assessed by ultrasound in all patients prior to discharge.

RESULTS: Overall complication rate was 3.9%. There were more complications after utilization of StarClose compared to ProGlide (5.6 vs. 2.2%, P = 0.064), which was significant in adjusted logistic regression analysis with a 2.9-fold increased risk of complications for StarClose (P < 0.05). In the subgroup of coronary catheterizations there were significantly more complications for StarClose compared to ProGlide (1.4 vs. 5.2%, P < 0.05) with a 4.7-fold increased risk. Device failure rate was not significantly different between the two devices.

CONCLUSION: In this first randomized trial comparing the two closure systems complication rate was higher for StarClose with equal efficacy compared to ProGlide. © 2017 Wiley Periodicals, Inc.