Impact of bivalirudin on outcomes after percutaneous coronary revascularization with drug-eluting stents

Background The direct thrombin inhibitor bivalirudin ha's been found to be noninferior to heparin plus planned glycoprotein (GP) llb/Illa blockade in the prevention of acute ischemic end points and 1-year mortality after percutaneous coronary intervention (PCl) with bare metal stents. We investigated whether long-term outcomes after bivalirudin use remained comparable to heparin plus GP llb/Illa 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 PCl with periprocedural use of bivalirudin or heparin plus GP llb/Illa platelet inhibitors. Patients presenting with an acute ST-elevation myocardial infarction (MI) <= 24 hours, thrombolytic therapy <= 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 llb/Illa 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/PCl, and Ml (6.9% vs 8.3%, P =.199) was similar in the bivaliruclin and heparin plus GP llb/Illa 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 llb/Illa inhibitor group. Mean clinical follow-up was 24.8 +/- 7.7 months. At follow-up, there were 87 (6.5%) deaths in the bivaliruclin group versus 42 (3.6%) in the heparin plus GP llb/Illa inhibitor group (hazard ratio 1.87, 95% Cl 1.30-2.71, P =.001). After a propensity score adjusted multivariate Cox analysis, bivaliruclin use was associated with a nonsignificant trend toward increased long-term mortality (hazard ratio 1.45, 95% Cl 0.98-2.16, P =.065). Conclusions Compared with heparin plus GP llb/Illa inhibition, routine use of bivaliruclin as the procedural anticoagulant in contemporary PCl with drug-eluting stents was associated with lower rates of inhospital complications and similar long-term all-cause mortality.