Short- and long-term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta-analysis of randomized trials.
BACKGROUND
Diabetes patients undergoing percutaneous coronary intervention (PCI) have more complications than nondiabetes patients, including increased long-term mortality. Use of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitors (GPI) in diabetes patients undergoing PCI and its effect on long-term mortality were evaluated in few randomized trials, but with conflicting results.


METHODS
We searched the literature for randomized controlled trials that compared heparin and GPI therapy with bivalirudin in diabetes patients undergoing PCI. The incidence of major adverse cardiovascular events (MACE), death from any cause, myocardial infarction (MI), urgent revascularization, major and minor bleeding (at 30 days), as well as all-cause mortality at 1 year were included, and meta-analysis was performed.


RESULTS
A total of 5,137 patients with diabetes were included in four randomized trials. At 30 days, bivalirudin, compared with heparin and GPI, caused less major bleeding (odds ratio (OR), 0.68; 95% confidence interval (CI), 0.52-0.89; P = 0.005) and less minor bleeding (OR, 0.48; 95% CI, 0.41-0.57; P < 0.00001) and similar rates of MACE (OR, 0.87; 95% CI, 0.70-1.08; P = 0.21), MI (OR, 0.87; 95% CI, 0.68-1.10; P = 0.25), and urgent revascularization (OR, 1.12; 95% CI, 0.76-1.65; P = 0.57). Death from any cause at 30 day was numerically lower with bivalirudin use but not statistically significant (OR, 0.72; 95% CI, 0.46-1.13; P = 0.15). Mortality at 1 year was significantly lower in diabetes patients treated with bivalirudin compared with heparin and GPI (OR, 0.72; 95% CI, 0.52-0.99; P = 0.04). A secondary analysis suggests that the major bleeding benefit with bivalirudin may be driven by mandated use of GPI in heparin arm.


CONCLUSIONS
Among patients with diabetes undergoing PCI, bivalirudin caused less major and minor bleeding compared with heparin and GPI, with similar rates of MACE, death, MI, and urgent revascularization at 30 days, but significantly lower mortality rates at 1 year.
Department of Cardiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Ramez
R
Nairooz
Department of Cardiology, University of Utah, Salt Lake City, Utah.
Partha
P
Sardar
Department of Medicine, New York Medical College-Metropolitan Hospital Center, New York City, New York.
Hossam
H
Amin
Department of Cardiology, St. Luke's-Roosevelt Hospital Center of the Mount Sinai Health System, New York City, New York.
Saurav
S
Chatterjee
Department of Cardiology, University of Cincinnati, Cincinnati, Ohio.
Tarek
T
Helmy
Department of Cardiology, Winthrop University Hospital, Mineola, New York.
Srihari S
SS
Naidu
D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D003327:Coronary Disease / Q000628:therapy*; D048909:Diabetes Complications; D004359:Drug Therapy, Combination; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D010446:Peptide Fragments / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
PCI; anticoagulation; bleeding; diabetes