Clinical experience with the use of bivalirudin in a large population undergoing endovascular abdominal aortic aneurysm repair.
OBJECTIVE
To retrospectively evaluate the safety and effectiveness of the use of bivalirudin, a direct thrombin antagonist, compared with unfractionated heparin in endovascular aneurysm repair (EVAR).


METHODS
Between March 1994 and September 2007, 740 consecutive patients (mean age, 75.7 y +/- 7.7; 69 women) underwent elective EVAR for infrarenal abdominal aortic aneurysm. Bivalirudin was used in 98 of these 740 (13.2%) and unfractioned heparin was used in the other 642 (86.8%). Complications were classified according to the Society of Vascular Surgery/International Society for Cardiovascular Surgery criteria. Major bleeding was defined as clinically overt blood loss resulting in a decrease of hemoglobin of more than 3 g/dL, any decrease in hemoglobin of more than 4 g/dL, transfusion of 2 U or more of red blood cells, or intracranial or retroperitoneal hemorrhage.


RESULTS
Grade 1 major complications were observed in 161 of 642 patients (25.2%) in the heparin group and 12 of 98 patients (12.2%) in the bivalirudin group (P = .0046), whereas the incidences of grade 3 major complications were not significantly different between groups (P = .57). The rate of total complications was higher in the heparin group than in the bivalirudin group (247 of 642 [38.5%] vs 21 of 98 [21.4%]; P = .001). Major bleeding occurred in 10 of 98 patients (10.2%) receiving bivalirudin and in 91 of 642 patients (14.2%) receiving heparin (P = .34). One of 21 major complications (4.76%) in the bivalirudin group and 12 of 247 major complications (4.86%) in the heparin group were attributable to thrombosis (P = 1.0).


CONCLUSIONS
Bivalirudin is a safe and feasible alternative to unfractionated heparin in patients undergoing EVAR.
Stamler
Sarah
S
University of Miami Miller School of Medicine, USA.
Katzen
Barry T
BT
Tsoukas
Athanassios I
AI
Baum
Samuel Z
SZ
Diehm
Nicolas
N
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D005240:Feasibility Studies; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D013917:Thrombin / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome
D000925:Anticoagulants; D006454:Hemoglobins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; D013917:Thrombin; C074619:bivalirudin