title: Meta-analysis of randomized clinical trials comparing bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention and in patients with ST-segment elevation myocardial infarction.
abstract: This study sought to investigate the relative safety and efficacy of bivalirudin versus heparin plus glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention (PCI) and in those with ST-segment elevation myocardial infarction (STEMI). The safety of bivalirudin in PCI, particularly in patients with STEMI, continues to be debated. We searched the on-line databases for randomized controlled trials of bivalirudin versus heparin plus GP IIb/IIIa inhibitors. Data on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes at 30 days were extracted. A total of 19,856 PCI patients included in 7 randomized trials and 5,820 patients with STEMI included in 2 randomized trials were separately analyzed. At 30 days, bivalirudin use in patients undergoing PCI resulted in similar rates of death, myocardial infarction, repeat revascularization, and stent thrombosis. In patients with STEMI, bivalirudin use resulted in decreased cardiac mortality (risk ratio [RR] 0.70, 95% confidence interval [CI] 0.50 to 0.97, p=0.03) compared with heparin plus GP IIb/IIIa inhibitors but an increase in definite stent thrombosis at 30 days (RR 1.88, 95% CI 1.09 to 3.24, p=0.02) driven by an increase in acute stent thrombosis (RR 5.48, 95% CI 2.30 to 13.07, p=0.0001). Bivalirudin use was associated with a decrease in Thrombolysis In Myocardial Infarction (TIMI) major (RR 0.58, 95% CI 0.46 to 0.74, p<0.0001) and TIMI minor (RR 0.55, 95% CI 0.48 to 0.63, p<0.0001) bleeding rates in PCI patients as well as in a subgroup of patients with STEMI. In conclusion, in PCI patients anticoagulation with bivalirudin results in similar ischemic adverse events and a reduction in TIMI major and minor bleeding at 30 days compared with heparin plus GP IIb/IIIa inhibitors. In patients with STEMI, bivalirudin use is associated with a reduction in TIMI major and minor bleeding and fewer deaths from cardiac causes but an increase in acute and 30-day definite stent thrombosis.
authors.affiliation: Department of Cardiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas. Electronic address: ramez.nairooz@gmail.com.
authors.forename: Ramez
authors.initials: R
authors.lastname: Nairooz
authors.affiliation: Department of Medicine, New York Medical College-Metropolitan Hospital Center, New York, New York.
authors.forename: Partha
authors.initials: P
authors.lastname: Sardar
authors.affiliation: Department of Cardiology, Texas Tech University Health Sciences Center, El Paso, Texas.
authors.forename: Hossam
authors.initials: H
authors.lastname: Amin
authors.affiliation: Division of Cardiology, Weill Cornell Medical College, NewYork-Presbyterian Hospital, New York, New York.
authors.forename: Rajesh V
authors.initials: RV
authors.lastname: Swaminathan
authors.affiliation: Department of Cardiology, Texas Tech University Health Sciences Center, El Paso, Texas.
authors.forename: Luke K
authors.initials: LK
authors.lastname: Kim
authors.affiliation: Department of Cardiology, St Luke's Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York, New York.
authors.forename: Saurav
authors.initials: S
authors.lastname: Chatterjee
authors.affiliation: Division of Cardiology, Weill Cornell Medical College, NewYork-Presbyterian Hospital, New York, New York.
authors.forename: Dmitriy N
authors.initials: DN
authors.lastname: Feldman
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D009203:Myocardial Infarction / Q000628:therapy*; D010446:Peptide Fragments / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011300:Preoperative Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin