Clinical Experience with the Use of Bivalirudin in a Large Population Undergoing Endovascular Abdominal Aortic Aneurysm Repair
Received 18 March 2008; received in revised form 25 September 2008; accepted 28 September 2008. published online 21 November 2008.
Purpose
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).
Materials and 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.
aUniversity of Miami Miller School of Medicine, Baptist Cardiac and Vascular Institute, 8900 North Kendall Drive, Miami, FL 33176
bDivision of Vascular Surgery, Baptist Cardiac and Vascular Institute, 8900 North Kendall Drive, Miami, FL 33176
cDivision of Clinical and Interventional Angiology and Vascular Research, Swiss Cardiovascular Center, Inselspital, University Hospital, Bern, Switzerland
Address correspondence to B.T.K.
None of the authors have identified a conflict of interest.
ABSTRACT