Temporal trends, safety, and efficacy of bivalirudin in elective percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.
OBJECTIVE
To evaluate the safety and efficacy of bivalirudin based therapy among patients undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease in a large multicenter registry.


BACKGROUND
The REPLACE I trial demonstrated the non-inferiority of a strategy of bivalirudin compared with heparin and glycoprotein (GP) IIbIIIa inhibition in patients undergoing PCI. There is a paucity of outcome data with bivalirudin use in the setting of real-world PCI practice.


METHODS
We evaluated the outcome of 11,719 patients who underwent elective PCI for stable coronary artery disease (CAD) from 2002 to 2004 in a large regional consortium, and who were treated with bivalirudin (n = 2051) or with heparin and GP IIbIIIa inhibitors (n = 9,668). The primary endpoints were transfusion and in-hospital major adverse cardiovascular events (MACE) defined as the composite of death, MI, stroke, and any coronary artery bypass grafting (CABG) or target lesion revascularization.


RESULTS
Compared with patients who received heparin plus GP IIbIIIa inhibitors, patients who received bivalirudin had a similar incidence of post-procedural MI, stroke, in-hospital death, MACE (2.88 vs. 2.48, P = 0.30), or transfusion (2.83% vs. 2.41%, P = 0.27). Patients at greater risk of bleeding were more likely to be treated with bivalirudin. After adjusting for the propensity to receive bivalirudin and for baseline co-morbidities, there was no difference in the odds of MACE or the need for transfusion between the two groups.


CONCLUSIONS
Compared with heparin plus GP IIbIIIa inhibition, use of bivalirudin in patients undergoing PCI for stable CAD is associated with similar ischemic and bleeding complications. Given the ease of administration and lower cost, bivalirudin provides an attractive treatment option in this patient population.
Gurm
Hitinder S
HS
University of Michigan, Ann Arbor, MI 48103-0311, USA.
Smith
Dean E
DE
Chetcuti
Stan J
SJ
Share
David
D
Khanal
Sanjaya
S
Riba
Arthur
A
Carter
Andrew J
AJ
Lalonde
Thomas
T
Kline-Rogers
Eva
E
O'Donnell
Michael
M
O'Neill
William
W
Safian
Robert
R
Moscucci
Mauro
M
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000628:therapy; D017558:Elective Surgical Procedures; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D008824:Michigan; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin