Safety evaluation of the use of femural percutaneous closure systems with simultaneous use of abciximab

Rev Port Cardiol. 2003 Sep;22(9):1063-72.
[Article in English, Portuguese]

Abstract

Introduction: The growing use of abciximab during coronary angioplasty, with 12 hours of intravenous perfusion, prolongs hospital stay and increases the risk of hemorrhage after sheath removal at the puncture site. Femoral percutaneous closure devices can reduce immobilization time, but their safety in the presence of abciximab in respect to hemorrhage has not been clearly determined.

Objectives: To evaluate the safety and efficacy of the Perclose system in patients undergoing angioplasty with abciximab.

Population and methods: The Perclose system was used in 79 patients undergoing angioplasty, with abciximab in 31 patients (58.6 +/- 12.2 years, 90% male, p = NS)--Group 1, and 48 pts without abciximab (61.8 +/- 10.9 years, 79% male, p = NS)--Group 2. We compared heparin dose, sheath diameters, primary success rate, coronary care unit admissions and minor and major complications. One patient was previously anticoagulated with warfarin and all the others were on oral antiplatelet therapy before and after angioplasty.

Results: Primary success with the use of the Perclose system was 78%. We found no significant statistical differences between groups in respect to the presence of diabetes, sheath diameter or referral for intervention. Heparin dosage was slightly higher in group 2 (p = 0.09) and ACT was also higher in group 2 (p = 0.01). More patients in group 1 had delayed ambulation (p = 0.04) due to abciximab perfusion. In 7 patients in group 1 and 9 in group 2, additional manual/mechanical compression was needed for moderate bleeding in the first hours (p = NS). One rupture of the femoral artery with need for surgical repair (primary failure) and another delayed rupture (48 hours) occurred in group 1 (both with an associated infection), and 1 pseudoaneurysm in a patient from group 2, without abciximab but taking warfarin (p = NS). None of the variables analyzed determined the occurrence of complications. Only oral anticoagulation determined the occurrence of major complications.

Conclusions: User of the Perclose system for percutaneous closure of the femoral artery in patients undergoing coronary angioplasty with simultaneous use of abciximab was not associated with greater morbidity than in patients without glycoprotein IIb/IIIa receptor antagonists.

Publication types

  • Clinical Trial

MeSH terms

  • Abciximab
  • Angioplasty, Balloon, Coronary*
  • Antibodies, Monoclonal / therapeutic use*
  • Anticoagulants / therapeutic use*
  • Female
  • Femoral Artery*
  • Humans
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Male
  • Middle Aged
  • Punctures / adverse effects
  • Punctures / instrumentation*

Substances

  • Antibodies, Monoclonal
  • Anticoagulants
  • Immunoglobulin Fab Fragments
  • Abciximab