title: Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.
abstract: BACKGROUND
  The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial demonstrated that bivalirudin monotherapy significantly reduces major bleeding compared with heparin (unfractionated or enoxaparin) or bivalirudin plus a glycoprotein IIb/IIIa inhibitor in acute coronary syndromes. Whether vascular closure devices (VCD) impact these results is unknown. Therefore, this study sought to determine whether VCD impact major access site bleeding (ASB) in patients with acute coronary syndromes undergoing early invasive management by the femoral approach.
  
  
  RESULTS
  Major ASB in ACUITY was defined as ASB requiring interventional or surgical correction, hematoma > or =5 cm at the access site, retroperitoneal bleeding, or hemoglobin drop > or =3 g/dL with ecchymosis or hematoma <5 cm, oozing blood, or prolonged bleeding (>30 minutes) at the access site. Stepwise logistical regression was performed to identify the independent determinants of ASB. Of 11 621 patients undergoing angiography with or without percutaneous coronary intervention by the femoral approach, 4307 (37.1%) received a VCD and 7314 (62.9%) did not. Rates of major ASB were lower with VCD compared with no VCD (2.5% versus 3.3%, relative risk, 0.76; 95% CI, 0.61 to 0.94; P=0.01) and were lowest in patients treated with bivalirudin monotherapy and a VCD (0.7%). Stepwise logistic regression revealed that a VCD (odds ratio, 0.78; 95% CI, 0.61 to 0.99; P=0.04) and bivalirudin monotherapy (odds ratio, 0.35; 95% CI, 0.25 to 0.49; P<0.0001) were both independent determinates of freedom from major ASB.
  
  
  CONCLUSIONS
  In patients with acute coronary syndromes undergoing an early invasive management strategy by the femoral approach, the use of a VCD, bivalirudin monotherapy, or both minimizes rates of major ASB. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique Identifier: NCT00093158.
authors.affiliation: Evanston Northwestern Healthcare, Ill, USA. tsanborn@northshore.org
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Sanborn
authors.forename: Ramin
authors.initials: R
authors.lastname: Ebrahimi
authors.forename: Steven V
authors.initials: SV
authors.lastname: Manoukian
authors.forename: Brent T
authors.initials: BT
authors.lastname: McLaurin
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D054058:Acute Coronary Syndrome / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004864:Equipment and Supplies; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006406:Hematoma / Q000453:epidemiology / Q000209:etiology*; D006493:Heparin / Q000031:analogs & derivatives / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin