Abstract 17613: Bivalirudin Leads to Less Major Bleeding but Does Not Reduce Major Cardiovascular Outcomes in Diabetes Patients Undergoing Percutaneous Coronary Intervention. A Pooled Analysis of Randomized Trials
Background: Effectiveness of bivalirudin in diabetes patients, as part of patients for percutaneous coronary intervention (PCI), has been evaluated in multiple trials but with conflicting results. A meta-analysis was performed to compare the efficacy and safety of bivalirudin versus heparin and glycoprotein IIbIIIA inhibitor (GPI) during PCI in diabetes patients as well as comparing outcomes of diabetes versus non diabetes patients. We hypothesize that Bivalirudin has better outcomes in diabetes patients, whom in general have more events with PCI.
Methods: We searched the literature for randomized control trials that compared heparin and GPI therapy with Bivalirudin alone in patients undergoing PCI, the sub analysis results for diabetes patients were used for this study. The incidence of Major Adverse Cardiovascular Events (MACE), death from any cause, Myocardial infarction (MI), urgent revascularization and major bleeding, at 30 days, were pooled and analyzed. Also events of diabetic patients in both treatment arms were compared with non-diabetic patients.
Results: A total of 23, 431 patients were included; 6069 patients were diabetic and 17,231 were non-diabetic. Bivalirudin in comparison to heparin and GPI in diabetes patients decreased major bleeding at 30 days (Odds Ratio (OR) 0.628, 95% CI [0.481, 0.819]; P 0.001) but didn’t seem to decrease MACE, death from any cause, MI or urgent revascularization. Compared to non-diabetic patients, diabetic patients had more MACE (OR 1.13, 95% CI [1.01, 1.26]; P 0.031), death from any cause (OR 1.75 95% CI [1.38, 2.2]; P <0.0001) and major bleeding (OR 1.29, 95% CI [1.13, 1.48]; P <0.0001).
Conclusion: Bivalirudin had an advantage over heparin and GPI in terms of less major bleeding but that didn’t translate to less major cardiovascular complications in this pooled analysis. Diabetic patients undergoing PCI tend to have more MACE, death and major bleeding than non diabetics.
- © 2013 by American Heart Association, Inc.