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


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


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.
Timóteo
Ana Teresa
AT
Serviço de Cardiologia, Hospital de Santa Cruz, Carnaxide. ana_timoteo@yahoo.com
Batista
José
J
Almeida
Manuel
M
Machado
Francisco Pereira
FP
Palos
José Luís
JL
Silva
José Aniceto
JA
Seabra-Gomes
Ricardo
R
D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use*; D005260:Female; D005263:Femoral Artery; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011677:Punctures / Q000009:adverse effects / Q000295:instrumentation*
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab