Document Detail


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.
MedLine Citation:
PMID:  20118151     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. METHODS AND 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:
Timothy A Sanborn; Ramin Ebrahimi; Steven V Manoukian; Brent T McLaurin; David A Cox; Frederick Feit; Martial Hamon; Roxana Mehran; Gregg W Stone
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-01-26
Journal Detail:
Title:  Circulation. Cardiovascular interventions     Volume:  3     ISSN:  1941-7632     ISO Abbreviation:  Circ Cardiovasc Interv     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-17     Completed Date:  2010-06-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101499602     Medline TA:  Circ Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  57-62     Citation Subset:  IM    
Affiliation:
Evanston Northwestern Healthcare, Ill, USA. tsanborn@northshore.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00093158
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / epidemiology,  physiopathology,  therapy*
Adult
Aged
Aged, 80 and over
Angiography
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects,  instrumentation*,  methods
Equipment and Supplies*
Female
Femoral Artery / surgery
Fibrinolytic Agents / therapeutic use
Hematoma / epidemiology,  etiology*
Heparin / analogs & derivatives,  therapeutic use
Hirudins
Humans
Incidence
Male
Middle Aged
Peptide Fragments / therapeutic use
Recombinant Proteins / therapeutic use
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; 0/Hirudins; 0/Peptide Fragments; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 9005-49-6/Heparin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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