Anticoagulation with bivalirudin for off-pump coronary artery bypass grafting: the results of the EVOLUTION-OFF study.
OBJECTIVE
Unfractionated heparin has many shortcomings, including indirect and partial inhibition of thrombin, antibody formation, and platelet activation. Bivalirudin, a short-acting direct thrombin inhibitor, avoids these limitations and has superior outcomes during percutaneous revascularization. This trial was performed to evaluate the safety and efficacy of bivalirudin in off-pump coronary artery bypass grafting.


METHODS
An open-label, multicenter randomized trial compared heparin with protamine reversal to bivalirudin in patients undergoing off-pump coronary artery bypass. The primary objective was safety as demonstrated by similar rates of procedural success defined as freedom from a composite of death, myocardial infarction, stroke, and repeat revascularization. Twenty-one institutions randomized 105 patients to receive bivalirudin and 52 patients to receive heparin.


RESULTS
The mean age was 65 years for both groups. The bivalirudin group had more grafts: 3.0 +/- 1 versus 2.5 +/- 1. Procedural success rates at 30 days were identical in bivalirudin- and heparin-treated patients (93%). Operative times, total blood loss, reoperations for bleeding, and major adverse events were not significantly different. Strokes were more frequent in the heparin group: 5.5% versus 0; P = .05. Mortality was 2% in each group. Repeat revascularization was required in 3% of bivalirudin- and 2% of the heparin-treated patients.


CONCLUSIONS
For patients undergoing off-pump coronary artery bypass grafting, bivalirudin was an effective anticoagulant, without excessive bleeding and with a safety profile similar to that of heparin. Further trials are warranted to assess whether anticoagulation with bivalirudin improves clinical outcomes.
Smedira
Nicholas G
NG
Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. smedirn@ccf.org
Dyke
Cornelius M
CM
Koster
Andreas
A
Jurmann
Michael
M
Bhatia
Devinder S
DS
Hu
Tingfei
T
McCarthy
Harry L
HL
Lincoff
A Michael
AM
Spiess
Bruce D
BD
Aronson
Solomon
S
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D047549:Coronary Artery Bypass, Off-Pump / Q000009:adverse effects; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006494:Heparin Antagonists / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011479:Protamines / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use
D000925:Anticoagulants; D006494:Heparin Antagonists; D006629:Hirudins; D010446:Peptide Fragments; D011479:Protamines; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin