Bivalirudin versus heparin and protamine in off-pump coronary artery bypass surgery.
BACKGROUND
Bivalirudin is a short-acting direct thrombin inhibitor, with advantages over unfractionated heparin for anticoagulation in cardiac surgery. We hypothesized that bivalirudin is not associated with a clinically important increase in blood loss compared with heparin with protamine reversal in patients undergoing off pump coronary artery bypass (OPCAB) surgery. We also assessed flow with angiography at 3 months using a modified Thombolysis in Myocardial Infarction (TIMI) grade in the grafted coronary arteries.


METHODS
One hundred patients were randomly assigned to receive bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion) or heparin (150 to 300 U/kg bolus) with protamine reversal.


RESULTS
A median of 3 (range, 1 to 5) grafts were inserted per patient. Blood loss for the 12 hours after study drug initiation in the bivalirudin group (median, 793 mL; interquartile range, 532 to 1,214 mL; range, 320 to 4,909 mL; n = 50) was not significantly greater than in the heparin group (median, 805 mL; interquartile range, 517 to 1,117 mL; range, 201 to 2,567 mL; n = 50; p = 0.165). Median graft flow was 3.0 in the bivalirudin group (n = 40) and 2.67 in the heparin group (n = 39; p = 0.047). The bivalirudin group had more patients with grade 3 (ie, full) flow in at least 1 graft (100% versus 90%; p = 0.04), a trend toward more patients with grade 3 flow in all grafts (60% versus 38%; p = 0.06), and more grafts with grade 3 flow (82% versus 67%; p = 0.03).


CONCLUSIONS
Anticoagulation for OPCAB surgery with bivalirudin was feasible without a clinically important increase in perioperative blood loss. Graft flow was better in the bivalirudin patients; the impact of this on clinical outcomes requires a larger study.
Department of Cardiothoracic Surgery, Green Lane Hospital, Auckland, New Zealand. a.merry@auckland.ac.nz
Alan F
AF
Merry
Peter J
PJ
Raudkivi
Neil G
NG
Middleton
John M
JM
McDougall
Parma
P
Nand
Brigid P
BP
Mills
Bruce J
BJ
Webber
Chris M
CM
Frampton
Harvey D
HD
White
D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage*; D000991:Antithrombins / Q000008:administration & dosage / Q000627:therapeutic use*; D016063:Blood Loss, Surgical; D001026:Coronary Artery Bypass / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006494:Heparin Antagonists / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage / Q000627:therapeutic use*; D011479:Protamines / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000925:Anticoagulants; D000991:Antithrombins; D006494:Heparin Antagonists; D006629:Hirudins; D010446:Peptide Fragments; D011479:Protamines; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin