Document Detail

Role of clopidogrel loading dose in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty: results from the HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial.
MedLine Citation:
PMID:  19796737     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Our aim was to determine whether a 600-mg loading dose of clopidogrel compared with 300 mg results in improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: A 600-mg loading dose of clopidogrel compared with 300 mg provides more rapid and potent inhibition of platelet activation. METHODS: In the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial, 3,602 patients with STEMI undergoing primary PCI were randomized to bivalirudin (n = 1,800) or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (n = 1,802). Randomization was stratified by thienopyridine loading dose, which was determined before random assignment. RESULTS: Patients in the 600-mg (n = 2,158) compared with the 300-mg (n = 1,153) clopidogrel loading dose group had significantly lower 30-day unadjusted rates of mortality (1.9% vs. 3.1%, p = 0.03), reinfarction (1.3% vs. 2.3%, p = 0.02), and definite or probable stent thrombosis (1.7% vs. 2.8%, p = 0.04), without higher bleeding rates. Compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin monotherapy resulted in similar reductions in net adverse cardiac event rates within the 300-mg (15.2% vs. 12.3%) and 600-mg (10.4% vs. 7.3%) clopidogrel loading dose subgroups (p(interaction) = 0.41). By multivariable analysis, a 600-mg clopidogrel loading dose was an independent predictor of lower rates of 30-day major adverse cardiac events (hazard ratio: 0.72 [95% confidence interval: 0.53 to 0.98], p = 0.04). CONCLUSIONS: In patients with STEMI undergoing primary PCI with contemporary anticoagulation regimens, a 600-mg loading dose of clopidogrel may safely reduce 30-day ischemic adverse event rates compared with a 300-mg loading dose. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).
George Dangas; Roxana Mehran; Giulio Guagliumi; Adriano Caixeta; Bernhard Witzenbichler; Jiro Aoki; Jan Z Peruga; Bruce R Brodie; Dariusz Dudek; Ran Kornowski; LeRoy E Rabbani; Helen Parise; Gregg W Stone;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  54     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-10-02     Completed Date:  2009-10-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1438-46     Citation Subset:  AIM; IM    
Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York 10022, USA.
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MeSH Terms
Acute Coronary Syndrome / drug therapy
Angioplasty, Balloon*
Anticoagulants / therapeutic use
Confidence Intervals
Logistic Models
Middle Aged
Multivariate Analysis
Myocardial Infarction / drug therapy*,  therapy
Peptide Fragments / therapeutic use
Platelet Aggregation Inhibitors / administration & dosage,  therapeutic use*
Proportional Hazards Models
Recombinant Proteins / therapeutic use
Ticlopidine / administration & dosage,  analogs & derivatives*,  therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Anticoagulants; 0/Hirudins; 0/Peptide Fragments; 0/Platelet Aggregation Inhibitors; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

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

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