Document Detail


Oral anticoagulant and antiplatelet therapy and peripheral arterial disease.
MedLine Citation:
PMID:  17634457     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Atherosclerotic peripheral arterial disease is associated with an increased risk of myocardial infarction, stroke, and death from cardiovascular causes. Antiplatelet drugs reduce this risk, but the role of oral anticoagulant agents in the prevention of cardiovascular complications in patients with peripheral arterial disease is unclear. METHODS: We assigned patients with peripheral arterial disease to combination therapy with an antiplatelet agent and an oral anticoagulant agent (target international normalized ratio [INR], 2.0 to 3.0) or to antiplatelet therapy alone. The first coprimary outcome was myocardial infarction, stroke, or death from cardiovascular causes; the second coprimary outcome was myocardial infarction, stroke, severe ischemia of the peripheral or coronary arteries leading to urgent intervention, or death from cardiovascular causes. RESULTS: A total of 2161 patients were randomly assigned to therapy. The mean follow-up time was 35 months. Myocardial infarction, stroke, or death from cardiovascular causes occurred in 132 of 1080 patients receiving combination therapy (12.2%) and in 144 of 1081 patients receiving antiplatelet therapy alone (13.3%) (relative risk, 0.92; 95% confidence interval [CI], 0.73 to 1.16; P=0.48). Myocardial infarction, stroke, severe ischemia, or death from cardiovascular causes occurred in 172 patients receiving combination therapy (15.9%) as compared with 188 patients receiving antiplatelet therapy alone (17.4%) (relative risk, 0.91; 95% CI, 0.74 to 1.12; P=0.37). Life-threatening bleeding occurred in 43 patients receiving combination therapy (4.0%) as compared with 13 patients receiving antiplatelet therapy alone (1.2%) (relative risk, 3.41; 95% CI, 1.84 to 6.35; P<0.001). CONCLUSIONS: In patients with peripheral arterial disease, the combination of an oral anticoagulant and antiplatelet therapy was not more effective than antiplatelet therapy alone in preventing major cardiovascular complications and was associated with an increase in life-threatening bleeding. (ClinicalTrials.gov number, NCT00125671 [ClinicalTrials.gov].).
Authors:
; Sonia Anand; Salim Yusuf; Changchun Xie; Janice Pogue; John Eikelboom; Andrzej Budaj; Bruce Sussex; Lisheng Liu; Randy Guzman; Claudio Cina; Richard Crowell; Matyas Keltai; Gilbert Gosselin
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  357     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-07-19     Completed Date:  2007-07-24     Revised Date:  2009-03-05    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  217-27     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2007 Massachusetts Medical Society.
Affiliation:
McMaster University, Hamilton, ON, Canada. anands@mcmaster.ca
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00125671
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MeSH Terms
Descriptor/Qualifier:
Acenocoumarol / therapeutic use
Administration, Oral
Anticoagulants / adverse effects,  therapeutic use*
Aspirin / therapeutic use
Atherosclerosis / drug therapy*
Cardiovascular Diseases / epidemiology,  mortality,  prevention & control*
Drug Therapy, Combination
Female
Follow-Up Studies
Hemorrhage / chemically induced,  mortality
Humans
Incidence
Male
Middle Aged
Peripheral Vascular Diseases / drug therapy*
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use*
Ticlopidine / analogs & derivatives,  therapeutic use
Warfarin / therapeutic use
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Platelet Aggregation Inhibitors; 152-72-7/Acenocoumarol; 50-78-2/Aspirin; 55142-85-3/Ticlopidine; 81-81-2/Warfarin; 90055-48-4/clopidogrel
Comments/Corrections
Comment In:
ACP J Club. 2007 Nov-Dec;147(3):60   [PMID:  17975862 ]
N Engl J Med. 2007 Jul 19;357(3):293-6   [PMID:  17634465 ]
Perspect Vasc Surg Endovasc Ther. 2008 Dec;20(4):383-4   [PMID:  19095638 ]
Kardiol Pol. 2007 Sep;65(9):1131-2; discussion 1133   [PMID:  18268816 ]

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


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