| 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. | |
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MedLine Citation:
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PMID: 20118151 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-01-26 |
Journal Detail:
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Title: Circulation. Cardiovascular interventions Volume: 3 ISSN: 1941-7632 ISO Abbreviation: Circ Cardiovasc Interv Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-02-17 Completed Date: 2010-06-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101499602 Medline TA: Circ Cardiovasc Interv Country: United States |
Other Details:
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Languages: eng Pagination: 57-62 Citation Subset: IM |
Affiliation:
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Evanston Northwestern Healthcare, Ill, USA. tsanborn@northshore.org |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00093158 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acute Coronary Syndrome
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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:
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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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