Bivalirudin as a foundation anticoagulant in peripheral vascular disease: a safe and feasible alternative for renal and iliac interventions.
BACKGROUND
Many heparin (UFH) limitations are overcome by bivalirudin (Angiomax ). The pharmacokinetic profile of bivalirudin appears well suited for percutaneous peripheral intervention (PPI), yet few data exist regarding its safety and feasibility in this setting.


METHODS
One hundred and eighty renal and 75 iliac PPIs performed between May 2001 and June 2002 with bivalirudin as anticoagulation were compared to a historical UFH control. Variables evaluated included thrombotic events, intracranial bleeding, major surgical complications, sheath removal time, vascular access complication, time to ambulate and length of stay (LOS). Follow-up included 6-month renal and iliac duplex ultrasound and ankle-brachial index.


RESULTS
Procedural success was achieved in 100% of patients treated with bivalirudin, with no thrombotic events, intracranial bleeding or major surgical complications observed. Procedural success was achieved in 179/180 (99%) renal and 74/75 (98.6%) iliac patients treated with UFH. Significant differences were observed for sheath removal time < 60 minutes (84% versus 59%; p < 0.0001), time to ambulation < 6 hours (75.5% versus 58%; p < 0.0005) and LOS < 24 hours (85.5% versus 72%; p = 0.002) in bivalirudin-treated renal PPI patients versus UFH-treated patients, respectively. Significant differences were also observed in favor of bivalirudin for the iliac PPIs for sheath removal time < 60 minutes (p = 0.012) and time to ambulation < 6 hours (p = 0.039). Following 6-month renal and iliac duplex ultrasound, repeat PPI was required in 7/180 (3.9%) and 9/180 (5%) of renal, and 3/75 (4%) and 4/75 (5.3%) of iliac patients treated with bivalirudin or UFH, respectively.


CONCLUSIONS
Bivalirudin is a safe and feasible alternative anticoagulant in renal and iliac PPI and may offer decreased sheath removal time, time to ambulation and LOS. A larger prospective randomized multicenter trial is warranted.
Allie
David E
DE
Cardiovascular Institute of the South, Lafayette and Houma, LA 70506, USA. David.Allie@cardio.com
Lirtzman
Mitchell D
MD
Wyatt
Charles H
CH
Keller
V Antoine
VA
Khan
Mohamed H
MH
Khan
Muhammad A
MA
Fail
Peter S
PS
Hebert
Chris J
CJ
Ellis
Sonja D
SD
Mitran
Elena
E
Chaisson
Gary
G
Stagg
Samuel
S
Allie
Adam A
AA
Walker
Craig M
CM
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000188:drug therapy*; D016022:Case-Control Studies; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006629:Hirudins / Q000031:analogs & derivatives*; D006801:Humans; D007083:Iliac Artery; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D016491:Peripheral Vascular Diseases / Q000175:diagnosis / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012078:Renal Artery Obstruction / Q000175:diagnosis / Q000188:drug therapy*; D012189:Retrospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome; D014654:Vascular Patency / Q000187:drug effects
D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin