Initial experience with a new femoral artery closure device following percutaneous coronary intervention with glycoprotein IIb/IIIa inhibition

• Published in: Catheterization and cardiovascular interventions 2005-10, Vol.66 (2), p.185-191
• Main Authors: Ruygrok, Peter N., Ormiston, John A., Stewart, James T., Webster, Mark W.I., El Jack, Seif, Simpson-Plaumann, Stephanie, Kay, I. Patrick, Chou, Tony M.
• Format: Article
• Language: English
• Subjects: Adult; Aged; angioplasty; Angioplasty, Balloon, Coronary; Aspirin - administration & dosage; Chi-Square Distribution; closure; Equipment Design; Feasibility Studies; Female; femoral artery; Femoral Artery - diagnostic imaging; Femoral Artery - surgery; Hemostasis, Surgical - instrumentation; Heparin - administration & dosage; Humans; intervention; Male; Middle Aged; Pilot Projects; Platelet Aggregation Inhibitors - administration & dosage; Platelet Glycoprotein GPIIb-IIIa Complex - antagonists & inhibitors; Prospective Studies; Punctures; Statistics, Nonparametric; Treatment Outcome; Ultrasonography
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.20484

The aim of the study was to determine the safety and efficacy of a novel femoral artery closure device (StarClose, Abbott Vascular Devices, Redwood City, CA) following percutaneous coronary intervention employing aspirin, heparin, and glycoprotein (GP) IIb/IIIa inhibition. A prospective nonrandomized single‐center pilot study of the StarClose device included a subset of patients undergoing percutaneous coronary intervention utilizing GP IIb/IIIa inhibitors. Those that fulfilled the inclusion criteria (age < 80, no periprocedural haematoma, puncture above the superficial femoral and profunda femoralis artery bifurcation, no significant femoral artery disease) underwent closure of the femoral artery puncture site with a StarClose device immediately on completion of the procedure. Time to hemostasis (TTH), bleeding, mobilization, and short‐term clinical follow‐up data were collected, and an ultrasound scan of the femoral artery was performed 2 weeks later. Twenty‐five patients were recruited, of whom 23 underwent percutaneous coronary intervention (PCI). Their mean age was 58 ± 12 years, 84% were male, and 63% had unstable angina. All were on aspirin 100–150 mg daily and all PCI patients received i.v. heparin 4–10,000 units at commencement of the procedure and clopidogrel 600 mg on completion. Two patients were on a tirofiban infusion and 23 received a double bolus of eptifibatide, each 0.18 mg/kg, separated by 10 min. The procedural success was 100% and device success 23/25 (92%), with 1 failure due to technical error. The median device delivery time was 36 sec (range, 11–178) and median TTH 37 sec (range, 10–509 sec). There were no major adverse events. In 10 patients, a moderate amount of tract ooze required a short period of adjunctive manual compression. Follow‐up ultrasound femoral artery scans revealed no compromise of the vessel lumen. Femoral artery closure with the device following coronary angiography and intervention using glycoprotein IIb/IIIa receptor inhibitors is safe and effective. A randomized trial of a larger number of patients is warranted. © 2005 Wiley‐Liss, Inc.