Similar success rates with bivalirudin and unfractionated heparin in bare-metal stent implantation.
BACKGROUND
Unfractionated heparin (UFH) is the traditional agent utilized during percutaneous peripheral interventions (PPIs) despite its well-known limitations. Bivalirudin, a thrombin-specific anticoagulant, overcomes many of the limitations of UFH and has consistently demonstrated comparable efficacy with significantly fewer bleeding complications. The purpose of this study was to compare procedural success in patients undergoing bare-metal stent implantation for atherosclerotic blockage of the renal, iliac, and femoral arteries and receiving either bivalirudin (0.75 mg/kg bolus/1.75 mg/kg/hr infusion) or UFH (50-70 U/kg/hr bolus) as the primary anticoagulant.


METHODS
This study was an open-label, nonrandomized retrospective registry with the primary endpoint of procedural success. Secondary endpoints included incidence of: death, myocardial infarction (MI), urgent revascularization, amputation, and major and minor bleeding.


RESULTS
One hundred and five consecutive patients were enrolled (bivalirudin = 53; heparin = 52). Baseline demographics were comparable between groups. Patients were pretreated with clopidogrel (approx. 71%) and aspirin (approx. 79%). Procedural success was achieved in 97% and 96% of patients in the bivalirudin- and heparin-treated groups, respectively. Event rates were low and similar between groups.


CONCLUSIONS
Bivalirudin maintained an equal rate of procedural success in this cohort without sacrificing patient safety. Results of this study add to the growing body of evidence supporting the safety and efficacy of bivalirudin as a possible substitute for UFH in anticoagulation during peripheral vascular bare-metal stent implantation.
Hallak
Omar
O
CAMC Institute, Centers for Clinical Science Research, Charleston, West Virginia, USA.
Shams
S Ali
SA
Broce
Mike
M
Lavigne
P Scott
PS
Lucas
B Daniel
BD
Elhabyan
Abdul-Karim
AK
Reyes
Bernardo J
BJ
D000368:Aged; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D050197:Atherosclerosis / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D007083:Iliac Artery; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D011474:Prosthesis Design; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012077:Renal Artery; D012107:Research Design; D012189:Retrospective Studies; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
D000925:Anticoagulants; D006629:Hirudins; D008670:Metals; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin