Abstract 4010: The Effect of Bivalirudin on Bleeding Risk in Patients with Chronic Renal Failure Undergoing Contemporary Percutaneous Coronary Intervention (PCI): an Analysis From a Large Multicenter PCI Registry
Background: Prior studies have shown the non-inferiority of bivalirudin compared with heparin and GP IIbIIIa inhibition in patients undergoing PCI, and have suggested a reduction in bleeding risk particularly in patients with chronic renal failure (CRF). There is however still a paucity of data in patients with CRF and in the setting of real-world PCI.
Methods: The study sample included 1,485 patients with CRF defined as admission Creatinine ≥2.0 mg/dL, and undergoing PCI in a large, multicenter, validated, regional PCI registry between April 2001 and March 2006. Of these, 406 patients were treated with bivalirudin and 1,079 patients were treated with heparin and GP IIbIIIa inhibitors. End-points evaluated included in-hospital death, GI bleeding, vascular complications, post-procedure transfusion and a combined major adverse cardiovascular event endpoint (MACE). Multivariate logistic regression modeling was used to adjust for comorbidities and for propensity of using bivalirudin.
Results: Compared with patients who received heparin plus GP IIbIIIa inhibitors, patients who received bivalirudin had a lower incidence of in-hospital death (1.97% vs. 4.26%, p=0.04), transfusion (10.6% vs. 19.3%, p<0.0001), GI bleeding (1.23% vs. 4.08, p<0.001), vascular complications (4.19% vs. 4.54, p=0.77) and MACE (4.19% vs. 7.78%, p=0.01). After adjusting for baseline co-morbidities and for the propensity to receive bivalirudin, there was no difference in the odds of death, MACE, GI bleeding and vascular complications, while there was a marked reduction in the odds ratio of transfusion (Adjusted OR 0.64, 95% CI 0.43– 0.94, p=0.02).
Conclusion: Use of bivalirudin (versus heparin) in an unselected population of patients with CRF undergoing PCI is associated with a marked reduction in the odds of blood transfusion, and with similar odds of MACE, death, GI bleeding and vascular complication.