| The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. | |
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MedLine Citation:
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PMID: 18929239 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: We sought to evaluate, in a double-blind, randomized, prospective study, safety and efficacy of elective percutaneous coronary intervention (PCI), with pharmacotherapy consisting of antiplatelet therapy and no anticoagulation therapy. BACKGROUND: Available guidelines recommend systemic anticoagulation agent use during PCI. Significant debate remains, however, with regard to the correlation between the effects of systemic anticoagulation therapy and ensuing ischemic and hemorrhagic complications. METHODS: From June 2005 to January 2007, 700 patients undergoing elective PCI of an uncomplicated lesion have been prospectively enrolled in the protocol. Patients should have been on aspirin and thienopyridine therapy and were assigned either to the control arm (70 to 100 UI/kg unfractionated heparin) or to the no-heparin arm. A clinical assessment was obtained before hospital discharge and at 30 days after PCI. RESULTS: Procedural success was obtained in 100% of the cases. No acute or subacute thrombosis was observed. The absence of anticoagulation therapy was associated with a significant decrease in post-procedural myocardial damage (p = 0.03) and bleeding events (p = 0.048). At 30 days, the primary end point (death, myocardial infarction, or urgent target vessel revascularization) was more frequent in the control arm than in the no-heparin arm (2.0% vs. 3.7%, respectively; absolute risk reduction 1.7% [95% confidence interval: -0.1% to 4.5%], p for superiority = 0.17, p for noninferiority <0.001). CONCLUSIONS: In the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications. |
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Authors:
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Eugenio Stabile; Wail Nammas; Luigi Salemme; Giovanni Sorropago; Angelo Cioppa; Tullio Tesorio; Vittorio Ambrosini; Esther Campopiano; Gregory Popusoi; Giuseppe Biondi Zoccai; Paolo Rubino |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of the American College of Cardiology Volume: 52 ISSN: 1558-3597 ISO Abbreviation: J. Am. Coll. Cardiol. Publication Date: 2008 Oct |
Date Detail:
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Created Date: 2008-10-20 Completed Date: 2008-11-04 Revised Date: 2009-05-18 |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 1293-8 Citation Subset: AIM; IM |
Affiliation:
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Laboratory of Invasive Cardiology, Division of Cardiology, Clinica Montevergine, Mercogliano, Italy. geko50@hotmail.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Transluminal, Percutaneous Coronary / methods* Anticoagulants / adverse effects, therapeutic use Chi-Square Distribution Combined Modality Therapy Confidence Intervals Coronary Angiography Coronary Stenosis / mortality, radiography, therapy* Double-Blind Method Female Follow-Up Studies Heparin / therapeutic use* Heparin, Low-Molecular-Weight / adverse effects, therapeutic use* Humans Male Middle Aged Probability Prospective Studies Reference Values Risk Assessment Severity of Illness Index Surgical Procedures, Elective / methods*, mortality Survival Rate Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Anticoagulants; 0/Heparin, Low-Molecular-Weight; 9005-49-6/Heparin |
| Comments/Corrections | |
Comment In:
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J Am Coll Cardiol. 2009 May 19;53(20):1921-2; author reply 922-3
[PMID:
19442895
]
J Am Coll Cardiol. 2008 Oct 14;52(16):1299-301 [PMID: 18929240 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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