Document Detail

The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention.
MedLine Citation:
PMID:  18929239     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
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:
Created Date:  2008-10-20     Completed Date:  2008-11-04     Revised Date:  2009-05-18    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1293-8     Citation Subset:  AIM; IM    
Laboratory of Invasive Cardiology, Division of Cardiology, Clinica Montevergine, Mercogliano, Italy.
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MeSH Terms
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
Follow-Up Studies
Heparin / therapeutic use*
Heparin, Low-Molecular-Weight / adverse effects,  therapeutic use*
Middle Aged
Prospective Studies
Reference Values
Risk Assessment
Severity of Illness Index
Surgical Procedures, Elective / methods*,  mortality
Survival Rate
Treatment Outcome
Reg. No./Substance:
0/Anticoagulants; 0/Heparin, Low-Molecular-Weight; 9005-49-6/Heparin
Comment In:
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 ]

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