Impact of bivalirudin on outcomes after percutaneous coronary revascularization with drug-eluting stents.
BACKGROUND
The direct thrombin inhibitor bivalirudin has been found to be noninferior to heparin plus planned glycoprotein (GP) IIb/IIIa blockade in the prevention of acute ischemic end points and 1-year mortality after percutaneous coronary intervention (PCI) with bare metal stents. We investigated whether long-term outcomes after bivalirudin use remained comparable to heparin plus GP IIb/IIIa blockade in current clinical practice of drug-eluting stent use.


METHODS
Using the 2004-2005 Cornell Angioplasty Registry, we studied 2504 consecutive patients undergoing urgent or elective PCI with periprocedural use of bivalirudin or heparin plus GP IIb/IIIa platelet inhibitors. Patients presenting with an acute ST-elevation myocardial infarction (MI) < or = 24 hours, thrombolytic therapy < or = 7 days, hemodynamic instability/shock, or renal insufficiency were excluded.


RESULTS
Of the study cohort, 1340 patients (54%) received bivalirudin and 1164 patients (46%) received heparin plus GP IIb/IIIa blockade. The incidence of inhospital mortality (0.3% vs 0.2%, P = .692), MI (6.6% vs 8.1%, P = .191), and combined end point of death, stroke, emergent coronary artery bypass graft/PCI, and MI (6.9% vs 8.3%, P = .199) was similar in the bivalirudin and heparin plus GP IIb/IIIa inhibitor groups. There was a lower incidence of major (0.7% vs 1.9%, P = .012) and minor bleeding (9.6% vs 15.6%, P < .001) in the bivalirudin versus heparin plus GP IIb/IIIa inhibitor group. Mean clinical follow-up was 24.8 +/- 7.7 months. At follow-up, there were 87 (6.5%) deaths in the bivalirudin group versus 42 (3.6%) in the heparin plus GP IIb/IIIa inhibitor group (hazard ratio 1.87, 95% CI 1.30-2.71, P = .001). After a propensity score adjusted multivariate Cox analysis, bivalirudin use was associated with a nonsignificant trend toward increased long-term mortality (hazard ratio 1.45, 95% CI 0.98-2.16, P = .065).


CONCLUSIONS
Compared with heparin plus GP IIb/IIIa inhibition, routine use of bivalirudin as the procedural anticoagulant in contemporary PCI with drug-eluting stents was associated with lower rates of inhospital complications and similar long-term all-cause mortality.
Feldman
Dmitriy N
DN
Division of Cardiology, New York Presbyterian Hospital-Weill Medical College of Cornell University, New York, NY 10021, USA.
Wong
S Chiu
SC
Gade
Christopher L
CL
Gidseg
David S
DS
Bergman
Geoffrey
G
Minutello
Robert M
RM
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D052279:Creatine Kinase, MB Form / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D007431:Intraoperative Complications / Q000517:prevention & control; D016015:Logistic Models; D008297:Male; D010446:Peptide Fragments / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D011994:Recombinant Proteins / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D015607:Stents; D016896:Treatment Outcome; D019210:Troponin I / Q000097:blood
D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D019210:Troponin I; D006493:Heparin; D052279:Creatine Kinase, MB Form; C074619:bivalirudin