Abstract 15919: Impact of Bivalirudin Therapy on Mortality in Patients With High Risk Features Undergoing PCI: A Patient-Level Pooled Analysis From the REPLACE-2, ACUITY and HORIZONS-AMI Trials
Background. Compared to Heparin + GP IIb/IIIa inhibitors (GPI), bivalirudin has been shown to decrease bleeding complications in several clinical presentations including: percutaneous coronary intervention (PCI) in stable ischemic syndromes, unstable angina, NSTEMI and STEMI (REPLACE-2, ACUITY and HORIZONS trials).While a survival benefit was observed in STEMI patients, this was not observed in other scenarios. We therefore investigated the impact of bivalirudin on survival in patients enrolled in these trials according to high risk clinical features (reduced LVEF, advanced age, diabetes mellitus (DM), anemia, chronic kidney disease (CKD), clinical presentation, and prior MI).
Methods. We examined the patient-based pooled data of the 3 randomized trials, identified 14,258 pts who received dual anti-platelet therapy undergoing PCI, and constructed a risk adjusted mortality model using the following variables: age>65, presence of DM, hypertension, creatinine clearance<60 m/min, LVEF<35%, NSTEMI, STEMI, previous MI and hematocrit<36%. Cox regression methods were used for statistical analysis.
Results. The relative risks of 1-year mortality favored bivalirudin compared to heparin + GPI and were concordant in the presence of each individual high risk feature examined; the lowest relative risk was associated with LVEF<35% (0.47, 0.30-0.72, p=0.0004). The presence of 3 or more risk factors (n=6176; 43.3% of all pts) was also associated with lower 1-month and 1-year mortality with bivalirudin therapy compared to GPI (Figure). Results were consistent in all three trials.
Conclusions. Treatment with bivalirudin may improve survival in patients with high risk features and ACS and/or undergoing PCI. The largest benefit was present in patients with moderate/severe LV dysfunction. Further studies are required to confirm these findings.
- © 2011 by American Heart Association, Inc.