PMID- 20197573 OWN - NLM STAT- MEDLINE DCOM- 20100610 LR - 20161125 IS - 1557-2501 (Electronic) IS - 1042-3931 (Linking) VI - 22 IP - 3 DP - 2010 Mar TI - Efficacy and safety of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention in current clinical practice. PG - 94-100 AB - OBJECTIVES: This study sought to evaluate the short- and long-term efficacy and safety of bivalirudin in diabetic patients undergoing percutaneous coronary intervention (PCI) in contemporary clinical practice. BACKGROUND: Early trials of platelet glycoprotein (GP) IIb/IIIa inhibitors have suggested a survival benefit in diabetic patients undergoing PCI. More recently, randomized trials have demonstrated that diabetic patients have similar protection from acute ischemic events, while lowering the risk of bleeding complications, when treated with bivalirudin monotherapy versus heparin plus GP IIb/IIIa blockade. However, the impact of bivalirudin use on long-term outcomes in diabetic patients undergoing PCI remains unclear. METHODS AND RESULTS: Using the Cornell Angioplasty Registry, we studied 786 consecutive diabetic patients undergoing urgent or elective PCI with a mean clinical follow up of 24.6 +/- 7.8 months. Of these, 428 patients (54.5%) received bivalirudin monotherapy and 358 patients (45.5%) received unfractionated heparin (UFH) plus GP IIb/IIIa inhibition. The incidence of in-hospital death (0% vs. 0.3%; p = 0.46), post-procedural myocardial infarction (MI) (4.7% vs. 7.0%; p = 0.169), and major adverse cardiovascular events (MACE) (death, MI, stroke or urgent revascularization) (4.9% vs. 7.3%; p = 0.176) was similar in the two groups, with less minor bleeding (9.6% vs. 14.5%; p = 0.035) in the bivalirudin vs. UFH plus GP IIb/IIIa inhibitor group, respectively. By the end of follow up, there were 38 (8.9%) deaths in the bivalirudin vs. 19 (5.3%) deaths in the GP IIb/IIIa inhibitor arm (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.0-3.1; p = 0.04). However, after a propensity score-adjusted multivariate Cox regression analysis, there was no longer a significant difference in long-term mortality between the two groups (HR 1.63; chi(2) = 2.61; 95% CI 0.90-2.94; p = 0.106). CONCLUSIONS: These findings indicate that in diabetic patients, bivalirudin monotherapy results in similar protection from acute ischemic events and long-term mortality, while lowering the risk of minor bleeding in comparison to UFH plus GP IIb/IIIa inhibition. FAU - Kim, Luke K AU - Kim LK AD - New York Presbyterian Hospital, Weill Cornell Medical College, Greenberg Division of Cardiology, 520 East 70th Street, New York, NY 10021, USA. FAU - Wong, S Chiu AU - Wong SC FAU - Minutello, Robert M AU - Minutello RM FAU - Bergman, Geoffrey AU - Bergman G FAU - Feldman, Dmitriy N AU - Feldman DN LA - eng PT - Comparative Study PT - Journal Article PL - United States TA - J Invasive Cardiol JT - The Journal of invasive cardiology JID - 8917477 RN - 0 (Anticoagulants) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM CIN - J Invasive Cardiol. 2010 Mar;22(3):101-2. PMID: 20197574 MH - Aged MH - *Angioplasty, Balloon, Coronary MH - Anticoagulants/administration & dosage/adverse effects/therapeutic use MH - Coronary Artery Disease/*etiology/*therapy MH - Diabetes Complications/*complications MH - Female MH - Follow-Up Studies MH - Heparin/therapeutic use MH - Hirudins/administration & dosage/adverse effects MH - Humans MH - Infusions, Intravenous MH - Logistic Models MH - Male MH - Middle Aged MH - Myocardial Infarction/*prevention & control MH - Peptide Fragments/administration & dosage/adverse effects/*therapeutic use MH - Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors MH - Recombinant Proteins/administration & dosage/adverse effects/therapeutic use MH - Registries MH - Retrospective Studies MH - Stroke/*prevention & control MH - Treatment Outcome EDAT- 2010/03/04 06:00 MHDA- 2010/06/11 06:00 CRDT- 2010/03/04 06:00 PHST- 2010/03/04 06:00 [entrez] PHST- 2010/03/04 06:00 [pubmed] PHST- 2010/06/11 06:00 [medline] PST - ppublish SO - J Invasive Cardiol. 2010 Mar;22(3):94-100.