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Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial.

Abstract

BACKGROUND

Chronic heart failure remains a major cause of mortality and morbidity. The role of antithrombotic therapy in patients with chronic heart failure has long been debated. The objective of this study was to determine the optimal antithrombotic agent for heart failure patients with reduced ejection fractions who are in sinus rhythm.

METHODS AND RESULTS

This prospective, randomized clinical trial of open-label warfarin (target international normalized ratio of 2.5 to 3.0) and double-blind treatment with either aspirin (162 mg once daily) or clopidogrel (75 mg once daily) had a 30-month enrollment period and a minimum of 12 months of treatment. We enrolled 1587 men and women >/=18 years of age with symptomatic heart failure for at least 3 months who were in sinus rhythm and had left ventricular ejection fraction of </=35%. The primary outcome was the time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke. For the primary composite end point, the hazard ratios were as follows: for warfarin versus aspirin, 0.98 (95% CI, 0.86 to 1.12; P=0.77); for clopidogrel versus aspirin, 1.08 (95% CI, 0.83 to 1.40; P=0.57); and for warfarin versus clopidogrel, 0.89 (95% CI, 0.68 to 1.16; P=0.39). Warfarin was associated with fewer nonfatal strokes than aspirin or clopidogrel. Hospitalization for worsening heart failure occurred in 116 (22.2%), 97 (18.5%), and 89 (16.5%) patients treated with aspirin, clopidogrel, and warfarin, respectively (P=0.02 for warfarin versus aspirin).

CONCLUSIONS

The primary outcome measure and the mortality data do not support the primary hypotheses that warfarin is superior to aspirin and that clopidogrel is superior to aspirin.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Veterans Affairs, San Francisco, CA, USA.

    , , , , , , , , , , ,

    Source

    Circulation 119:12 2009 Mar 31 pg 1616-24

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Aspirin
    Chronic Disease
    Clopidogrel
    Death
    Double-Blind Method
    Female
    Fibrinolytic Agents
    Heart Failure
    Humans
    Male
    Middle Aged
    Myocardial Infarction
    Stroke
    Stroke Volume
    Ticlopidine
    Warfarin

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, Non-P.H.S.

    Language

    eng

    PubMed ID

    19289640

    Citation

    Massie, Barry M., et al. "Randomized Trial of Warfarin, Aspirin, and Clopidogrel in Patients With Chronic Heart Failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial." Circulation, vol. 119, no. 12, 2009, pp. 1616-24.
    Massie BM, Collins JF, Ammon SE, et al. Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial. Circulation. 2009;119(12):1616-24.
    Massie, B. M., Collins, J. F., Ammon, S. E., Armstrong, P. W., Cleland, J. G., Ezekowitz, M., ... Warren, S. R. (2009). Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial. Circulation, 119(12), pp. 1616-24. doi:10.1161/CIRCULATIONAHA.108.801753.
    Massie BM, et al. Randomized Trial of Warfarin, Aspirin, and Clopidogrel in Patients With Chronic Heart Failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial. Circulation. 2009 Mar 31;119(12):1616-24. PubMed PMID: 19289640.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial. AU - Massie,Barry M, AU - Collins,Joseph F, AU - Ammon,Susan E, AU - Armstrong,Paul W, AU - Cleland,John G F, AU - Ezekowitz,Michael, AU - Jafri,Syed M, AU - Krol,William F, AU - O'Connor,Christopher M, AU - Schulman,Kevin A, AU - Teo,Koon, AU - Warren,Stuart R, AU - ,, Y1 - 2009/03/16/ PY - 2009/3/18/entrez PY - 2009/3/18/pubmed PY - 2009/4/25/medline SP - 1616 EP - 24 JF - Circulation JO - Circulation VL - 119 IS - 12 N2 - BACKGROUND: Chronic heart failure remains a major cause of mortality and morbidity. The role of antithrombotic therapy in patients with chronic heart failure has long been debated. The objective of this study was to determine the optimal antithrombotic agent for heart failure patients with reduced ejection fractions who are in sinus rhythm. METHODS AND RESULTS: This prospective, randomized clinical trial of open-label warfarin (target international normalized ratio of 2.5 to 3.0) and double-blind treatment with either aspirin (162 mg once daily) or clopidogrel (75 mg once daily) had a 30-month enrollment period and a minimum of 12 months of treatment. We enrolled 1587 men and women >/=18 years of age with symptomatic heart failure for at least 3 months who were in sinus rhythm and had left ventricular ejection fraction of </=35%. The primary outcome was the time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke. For the primary composite end point, the hazard ratios were as follows: for warfarin versus aspirin, 0.98 (95% CI, 0.86 to 1.12; P=0.77); for clopidogrel versus aspirin, 1.08 (95% CI, 0.83 to 1.40; P=0.57); and for warfarin versus clopidogrel, 0.89 (95% CI, 0.68 to 1.16; P=0.39). Warfarin was associated with fewer nonfatal strokes than aspirin or clopidogrel. Hospitalization for worsening heart failure occurred in 116 (22.2%), 97 (18.5%), and 89 (16.5%) patients treated with aspirin, clopidogrel, and warfarin, respectively (P=0.02 for warfarin versus aspirin). CONCLUSIONS: The primary outcome measure and the mortality data do not support the primary hypotheses that warfarin is superior to aspirin and that clopidogrel is superior to aspirin. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/19289640/full_citation L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.108.801753?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -