title: Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial.
abstract: OBJECTIVE
  The safety and efficacy of bivalirudin compared with heparin with or without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI) are uncertain.
  
  
  OBJECTIVE
  To determine if bivalirudin is superior to heparin alone and to heparin plus tirofiban during primary PCI.
  
  
  METHODS
  Multicenter, open-label trial involving 2194 patients with AMI undergoing primary PCI at 82 centers in China between August 2012 and June 2013.
  
  
  METHODS
  Patients were randomly assigned to receive bivalirudin with a post-PCI infusion (n = 735), heparin alone (n = 729), or heparin plus tirofiban with a post-PCI infusion (n = 730). Among patients treated with bivalirudin, a postprocedure 1.75 mg/kg/h infusion was administered for a median of 180 minutes (IQR, 148-240 minutes).
  
  
  METHODS
  The primary end point was 30-day net adverse clinical events, a composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or bleeding. Additional prespecified safety end points included the rates of acquired thrombocytopenia at 30 days, and stent thrombosis at 30 days and 1 year.
  
  
  RESULTS
  Net adverse clinical events at 30 days occurred in 65 patients (8.8%) of 735 who were treated with bivalirudin compared with 96 patients (13.2%) of 729 treated with heparin (relative risk [RR], 0.67; 95% CI, 0.50-0.90; difference, -4.3%, 95% CI, -7.5% to -1.1%; P = .008); and 124 patients (17.0%) of 730 treated with heparin plus tirofiban (RR for bivalirudin vs heparin plus tirofiban, 0.52; 95% CI, 0.39-0.69; difference, -8.1%, 95% CI, -11.6% to -4.7%; P < .001). The 30-day bleeding rate was 4.1% for bivalirudin, 7.5% for heparin, and 12.3% for heparin plus tirofiban (P < .001). There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events (5.0% for bivalirudin, 5.8% for heparin, and 4.9% for heparin plus tirofiban, P = .74), stent thrombosis (0.6% vs 0.9% vs 0.7%, respectively, P = .77), acquired thrombocytopenia (0.1% vs 0.7% vs 1.1%; P = .07), or in acute (<24-hour) stent thrombosis (0.3% in each group). At the 1-year follow-up, the results remained similar.
  
  
  CONCLUSIONS
  Among patients with AMI undergoing primary PCI, the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion resulted in a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban. This finding was primarily due to a reduction in bleeding events with bivalirudin, without significant differences in major adverse cardiac or cerebral events or stent thrombosis.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01696110.
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
authors.affiliation: Luhe Hospital, Capital Medical University, Beijing, China.
authors.forename: Jincheng
authors.initials: J
authors.lastname: Guo
authors.affiliation: The First Hospital of Jilin University, Changchun, Jilin Province, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: No. 463 Hospital of PLA, Shenyang, Liaoning Province, China.
authors.forename: Hongyun
authors.initials: H
authors.lastname: Zang
authors.affiliation: Wuhan Asia Heart Hospital, Wuhan, Hubei Province, China.
authors.forename: Xi
authors.initials: X
authors.lastname: Su
authors.affiliation: General Hospital of People's Liberation Army, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Nanjing First Hospital, Nanjing, Jiangsu Province, China.
authors.forename: Shaoliang
authors.initials: S
authors.lastname: Chen
authors.affiliation: Affiliated Hospital of Logistics University of CAPF, Tianjin, China.
authors.forename: Tiemin
authors.initials: T
authors.lastname: Jiang
authors.affiliation: The Third Hospital of Jilin University, Changchun, Jilin Province, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Yang
authors.affiliation: Guangdong General Hospital, Guangdong Province, China.
authors.forename: Jiyan
authors.initials: J
authors.lastname: Chen
authors.affiliation: No. 210 Hospital of PLA, Dalian, Liaoning Province, China.
authors.forename: Dongju
authors.initials: D
authors.lastname: Jiang
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Quanmin
authors.initials: Q
authors.lastname: Jing
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Zhenyang
authors.initials: Z
authors.lastname: Liang
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Haiwei
authors.initials: H
authors.lastname: Liu
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhao
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D000077466:Tirofiban; D014443:Tyrosine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D014443:Tyrosine; D006493:Heparin; D000077466:Tirofiban; C074619:bivalirudin