Abstract

OBJECTIVES:

This study sought to evaluate the frequency and efficacy of combination of bivalirudin and provisional glycoprotein (GP) IIb/IIIa blockade compared with bivalirudin monotherapy in current clinical practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES).

BACKGROUND:

Previous randomized trials have demonstrated that a strategy of bivalirudin with provisional (bailout) GP IIb/IIIa inhibition was non-inferior to unfractionated heparin (UFH) plus planned GP IIb/IIIa blockade for the prevention of acute and long-term adverse clinical events. However, the frequency and efficacy of provisional GP IIb/IIIa inhibition in addition to the full-dose bivalirudin in current practice is not well established.

METHODS:

Using the 2004/2005 Cornell Angioplasty Registry, we studied 1,340 consecutive patients undergoing urgent or elective PCI with periprocedural use of bivalirudin. We excluded patients presenting with an acute ST-elevation myocardial infarction (MI) within < or = 24 hours, hemodynamic instability/shock, thrombolytic therapy within < or = 7 days, or renal insufficiency. Mean clinical follow up was 24.2 +/- 7.7 months.

RESULTS:

Of the study cohort, 1,184 patients (88.4%) received bivalirudin alone and 156 (11.6%) received bivalirudin plus bailout GP IIb/IIIa blockade. DES were used in 86% of PCIs. The incidence of in-hospital mortality (0% vs. 0.3% p = 1.000), MI (7.1% vs. 6.6%; p = 0.864), and the combined endpoint of death, stroke, emergent coronary artery bypass graft surgery (CABG)/PCI, or MI (7.1% vs. 6.9%; p = 0.868) were similar in the bivalirudin-plus-bailout GP IIb/IIIa inhibitor versus the bivalirudin-alone arm. There was a higher incidence of bleeding complications (16.0% vs. 9.6%; p = 0.018) in the bivalirudin-plus-bailout GP IIb/IIIa versus the bivalirudin-alone group. At follow up, there were 4 (2.6%) deaths in the bivalirudin-plus-GP IIb/IIIa inhibitor group versus 83 (7.0%) deaths in the bivalirudin-alone arm (HR 0.36, 95% confidence interval [CI] 0.13-0.98; p = 0.044). After multivariate Cox regression analysis, bailout GP IIb/IIIa use in addition to bivalirudin was associated with similar long-term survival when compared to bivalirudin monotherapy (HR 0.41, 95% CI 0.15-1.12; p = 0.081).

CONCLUSIONS:

Provisional GP IIb/IIIa use in bivalirudin-treated patients is higher in contemporary non-emergent PCI practice than that seen in randomized trials and is associated with similar in-hospital ischemic events, but more frequent bleeding events. These data suggest that a strategy of bivalirudin monotherapy is preferable in order to reduce bleeding complications, and GP IIb/IIIa blockade should be reserved for patients with periprocedural complications in bivalirudin-treated patients undergoing PCI.