title: Bivalirudin Versus Heparin Plus Glycoprotein IIb/IIIa Inhibitors in Patients with Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials.
abstract: Diabetes mellitus (DM) is a pro-thrombotic state with enhanced thrombin generation and platelet reactivity. For most patients undergoing percutaneous coronary intervention (PCI), bivalirudin demonstrates efficacy comparable with that of heparin and glycoprotein IIb/IIIa inhibitors (GPIs). Yet, because of their pro-thrombotic condition, we hypothesized that patients with DM may benefit from more aggressive dual antithrombin and antiplatelet therapy. The aim of this paper was to provide a systematic review comparing outcomes of PCI with bivalirudin versus heparin plus GPI in patients with DM using meta-analytical techniques. Eligible studies needed to have reported a subgroup analysis of outcomes among diabetic patients. Six trials comprising 5924 diabetic patients were eligible. At 30 days, bivalirudin was associated with a reduction in net adverse cardiac events [relative risk (RR) 0.81, 95 % confidence interval (CI) 0.70-0.93, p = 0.002] and major bleeds (RR 0.68, 95 % CI 0.49-0.95; p = 0.02), with no difference in composite ischemia (RR 0.92, 95 % CI 0.74-1.14; p = 0.43) or mortality (RR 0.71, 95 % CI 0.45-1.13; p = 0.15). At 1 year, bivalirudin was associated with a significant reduction in all-cause mortality (RR 0.73, 95 % CI 0.54-1.00, p = 0.05) despite similar composite ischemia (RR 1.02, 95 % CI 0.56-1.21, p = 0.811). In conclusion, thrombin inhibition with bivalirudin alone was associated with reduced 30-day major bleeding and 1-year all-cause mortality compared with heparin plus GPI in diabetic patients undergoing PCI.
authors.affiliation: Division of Cardiovascular Diseases, University of Tennessee Health Sciences Center, 365 Court Avenue, Suite D334, Memphis, TN, 38163, USA, uibebuog@uthsc.edu.
authors.forename: Uzoma N
authors.initials: UN
authors.lastname: Ibebuogu
authors.forename: Oluwaseyi
authors.initials: O
authors.lastname: Bolorunduro
authors.forename: Smith
authors.initials: S
authors.lastname: Giri
authors.forename: Sam
authors.initials: S
authors.lastname: Dagogo-Jack
authors.forename: Blake G
authors.initials: BG
authors.lastname: Smith
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Guy L
authors.initials: GL
authors.lastname: Reed
mesh_terms: D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects; D001777:Blood Coagulation / Q000187:drug effects; D023903:Coronary Restenosis / Q000517:prevention & control*; D048909:Diabetes Complications / Q000097:blood*; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D017063:Outcome Assessment, Health Care; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin