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.