title: The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial.
abstract: BACKGROUND
  Being female is an independent predictor of adverse events during percutaneous coronary interventions (PCI).
  
  
  OBJECTIVE
  To evaluate the safety and efficiency of bivalirudin during emergency PCI in female patients with acute myocardial infarction (AMI).
  
  
  METHODS
  The present study was a subgroup analysis of the randomized Bivalirudin in Acute Myocardial Infarction vs. Heparin and GPI plus Heparin (BRIGHT) trial. A total of 392 female patients enrolled in the BRIGHT trial were assigned to receive bivalirudin with post-procedure dose infusion (n = 127) or heparin with or without tirofiban (n = 265). The primary efficiency endpoint was 30-day net adverse clinical events (NACEs). The secondary efficiency endpoints were 30-day major cardiac and cerebral events (MACCEs) and bleeding events defined according to Bleeding Academic Research Consortium (BARC) definitions.
  
  
  RESULTS
  For female patients, bivalirudin treatment was associated with significantly lower incidences of 30-day NACEs (6.3% vs. 21.5%, P < 0.001), any bleeding (2.4% vs. 12.8%, P = 0.001) and BARC 2-5 type bleeding (1.6% vs. 7.2%, P = 0.021) compared with the control regimen. The incidence of MACCEs (3.4% vs. 9.4%, P = 0.055) and stent thrombosis (0% vs. 1.1%, P = 0.229) were comparable between the two groups. Multivariate analysis showed that bivalirudin (OR: 0.245, 95% CI: 0.113-0.532, P < 0.001), transradial access (OR: 0.119, 95% CI: 0.067-0.211, P < 0.001), and statin (OR: 0.254, 95% CI: 0.08-0.807, P = 0.02) were independent protective factors for 30-day NACEs in female patients.
  
  
  CONCLUSIONS
  The use of bivalirudin during emergency PCI for AMI in female patients significantly reduced the bleeding risk with anticoagulation effects compared with heparin with or without tirofiban.
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: Yi
authors.initials: Y
authors.lastname: Li
authors.affiliation: Shanxi Cardiovascular Hospital, Taiyuan, Shanxi Province, China.
authors.forename: Jingping
authors.initials: J
authors.lastname: Wang
authors.affiliation: Shijiazhuang Peace Hospital, Shijiazhuang, Hebei Province, China.
authors.forename: Dongmei
authors.initials: D
authors.lastname: Wang
authors.affiliation: No. 306 Hospital of PLA, Beijing, Beijing City, China.
authors.forename: Shouli
authors.initials: S
authors.lastname: Wang
authors.affiliation: Anhui Provincial Hospital, Hefei, Anhui Province, China.
authors.forename: Likun
authors.initials: L
authors.lastname: Ma
authors.affiliation: Beijing CAPF General Hospital, Beijing, Beijing City, China.
authors.forename: Huiliang
authors.initials: H
authors.lastname: Liu
authors.affiliation: Kunming General Hospital of Chengdu Military Region, Kunming, Yunnan Province, China.
authors.forename: Lixia
authors.initials: L
authors.lastname: Yang
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D004638:Emergency Treatment; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D016017:Odds Ratio; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011446:Prospective Studies; D065840:Protective Factors; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D000077466:Tirofiban; D016896:Treatment Outcome; D014443:Tyrosine / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D014443:Tyrosine; D006493:Heparin; D000077466:Tirofiban; C074619:bivalirudin
keywords: acute myocardial infarction; bivalirudin; female