Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study

Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We con...

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Veröffentlicht in:Circulation (New York, N.Y.) N.Y.), 2002-02, Vol.105 (5), p.557-563
Hauptverfasser: FIORE, Louis D, EZEKOWITZ, Michael D, BROPHY, Mary T, LU, David, SACCO, Joseph, PEDUZZI, Peter
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container_end_page 563
container_issue 5
container_start_page 557
container_title Circulation (New York, N.Y.)
container_volume 105
creator FIORE, Louis D
EZEKOWITZ, Michael D
BROPHY, Mary T
LU, David
SACCO, Joseph
PEDUZZI, Peter
description Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P
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We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P&lt;0.001). There were 14 individuals with intracranial bleeds in both the aspirin and combination therapy groups. In post-myocardial infarction patients, warfarin therapy (at a mean international normalized ratio of 1.8) combined with low-dose aspirin did not provide a clinical benefit beyond that achievable with aspirin monotherapy.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/hc0502.103329</identifier><identifier>PMID: 11827919</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams &amp; Wilkins</publisher><subject>Anti-Inflammatory Agents, Non-Steroidal - adverse effects ; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use ; Anticoagulants - adverse effects ; Anticoagulants - therapeutic use ; Aspirin - adverse effects ; Aspirin - therapeutic use ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Hemorrhage - etiology ; Hospitals, Veterans ; Humans ; International Normalized Ratio - statistics &amp; numerical data ; Male ; Medical sciences ; Middle Aged ; Myocardial Infarction - drug therapy ; Pharmacology. Drug treatments ; Proportional Hazards Models ; Risk Assessment ; Survival Rate ; Treatment Outcome ; United States ; Warfarin - adverse effects ; Warfarin - therapeutic use</subject><ispartof>Circulation (New York, N.Y.), 2002-02, Vol.105 (5), p.557-563</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright American Heart Association, Inc. 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Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P&lt;0.001). There were 14 individuals with intracranial bleeds in both the aspirin and combination therapy groups. 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We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P&lt;0.001). There were 14 individuals with intracranial bleeds in both the aspirin and combination therapy groups. In post-myocardial infarction patients, warfarin therapy (at a mean international normalized ratio of 1.8) combined with low-dose aspirin did not provide a clinical benefit beyond that achievable with aspirin monotherapy.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams &amp; Wilkins</pub><pmid>11827919</pmid><doi>10.1161/hc0502.103329</doi><tpages>7</tpages></addata></record>
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source MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete
subjects Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
Anticoagulants - adverse effects
Anticoagulants - therapeutic use
Aspirin - adverse effects
Aspirin - therapeutic use
Biological and medical sciences
Blood. Blood coagulation. Reticuloendothelial system
Drug Therapy, Combination
Female
Follow-Up Studies
Hemorrhage - etiology
Hospitals, Veterans
Humans
International Normalized Ratio - statistics & numerical data
Male
Medical sciences
Middle Aged
Myocardial Infarction - drug therapy
Pharmacology. Drug treatments
Proportional Hazards Models
Risk Assessment
Survival Rate
Treatment Outcome
United States
Warfarin - adverse effects
Warfarin - therapeutic use
title Department of veterans affairs cooperative studies program clinical trial comparing combined warfarin and aspirin with aspirin alone in survivors of acute myocardial infarction: Primary results of the CHAMP study
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