Abstract 2653: Bivalirudin Use Is Associated with Increased Long-Term Mortality in ACS Patients Undergoing Drug-Eluting Stents Implantation
Background: In a randomized trial (ACUITY), bivalirudin with provisional GP IIb/IIIa inhibition was found to be noninferior to heparin plus GP IIb/IIIa blockade for the prevention of acute ischemic events in PCI for ACS. The impact of bivalirudin use on long-term outcomes in ACS patients undergoing PCI with drug-eluting stents (DES) is unknown.
Methods: Using the 2004/2005 Cornell Angioplasty Registry, we studied 1,523 consecutive patients undergoing urgent or elective PCI for ACS with peri-procedural use of bivalirudin or GP IIb/IIIa platelet inhibitors. Patients presenting with an acute MI ≤24 hours, hemodynamic instability/shock, thrombolytic therapy ≤7 days were excluded. Mean clinical follow-up was 440 days (range 1– 818 days).
Results: We studied 836 patients (54.9%) receiving bivalirudin and 687 (45.1%) receiving GP IIb/IIIa inhibitors. DES were used in 87% of PCI. The incidence of in-hospital death (0.4% vs. 0.1%, p=0.63), non-Q-wave MI (7.3% vs. 7.0%, p=0.82), and MACE (death, CVA, emergent CABG/PCI) (7.5% vs. 7.1%, p=0.84) was similar in the bivalirudin and GP IIb/IIIa inhibitor arms. By follow-up, there were 36 (4.3%) deaths in the bivalirudin vs. 14 (2.0%) in the GP IIb/IIIa inhibitor arm (HR 2.2, 95%CI 1.2– 4.0, p=0.01) (Figure⇓). After multivariate Cox analysis, bivalirudin use remained an independent predictor of long-term mortality (HR 2.0, 95%CI 1.0 −3.8, p=0.04).
Conclusion: These data suggest that routine use of bivalirudin with provisional GP IIb/IIIa blockade in ACS patients treated with DES may be associated with increased long-term mortality. Long-term follow-up data from a prospective, randomized, double-blind ACS trial in the era of DES are needed.