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Effect of low-dose aspirin on the occurrence of venous thromboembolism: a randomized trial.

Abstract

BACKGROUND

Short-term aspirin therapy can lower the risk for venous thromboembolism (VTE) in high-risk patients, but whether the long-term use of low-dose aspirin reduces risk in healthy adults is uncertain.

OBJECTIVE

To test the efficacy of long-term aspirin therapy for preventing VTE.

DESIGN

Secondary analysis of a 10-year randomized, double-blind, placebo-controlled trial.

SETTING

U.S. female health care professionals in the Women's Health Study.

PARTICIPANTS

39,876 initially healthy women age 45 years or older (26,779 gave blood samples that were evaluated for factor V Leiden, G20210A prothrombin, and MTHFR 677C>T polymorphisms).

MEASUREMENTS

Documented VTE (deep venous thrombosis or pulmonary embolism) and unprovoked VTE (no recent surgery, trauma, or cancer diagnosis) were prospectively evaluated, secondary end points.

INTERVENTION

Aspirin, 100 mg, or placebo on alternate days.

RESULTS

Venous thromboembolism occurred in 482 women during follow-up, an incidence higher than that of myocardial infarction and nearly equal to that of stroke. The incidence of VTE (per 1000 person-years) was 1.18 among women randomly assigned to active aspirin, compared with 1.25 among women randomly assigned to placebo (relative hazard, 0.95 [95% CI, 0.79 to 1.13]; rate difference, -0.06 [CI, -0.28 to 0.16]). For unprovoked VTE, the relative hazard was 0.90 (CI, 0.70 to 1.16) and the rate difference was -0.06 (CI, -0.21 to 0.10). Relative hazards associated with aspirin use in higher-risk subgroups were 0.83 (CI, 0.50 to 1.39) among women with either factor V Leiden or the prothrombin mutation and 1.36 (CI, 0.77 to 2.41) among those with a history of VTE.

LIMITATION

Venous thromboembolism was a secondary end point in the Women's Health Study.

CONCLUSION

These data suggest that long-term, low-dose aspirin treatment has little effect on the prevention of VTE in initially healthy women. ClinicalTrials.gov registration number: NCT00000479.

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  • Authors+Show Affiliations

    ,

    Brigham and Women's Hospital, Harvard Medical School, and Harvard School of Public Health, Boston, Massachusetts 02215, USA. rglynn@rics.bwh.harvard.edu .

    , ,

    Source

    Annals of internal medicine 147:8 2007 Oct 16 pg 525-33

    MeSH

    Aspirin
    Double-Blind Method
    Drug Administration Schedule
    Female
    Fibrinolytic Agents
    Follow-Up Studies
    Hemorrhage
    Humans
    Incidence
    Middle Aged
    Peptic Ulcer
    Prospective Studies
    Risk Factors
    Thromboembolism
    Venous Thrombosis

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    17938390

    Citation

    Glynn, Robert J., et al. "Effect of Low-dose Aspirin On the Occurrence of Venous Thromboembolism: a Randomized Trial." Annals of Internal Medicine, vol. 147, no. 8, 2007, pp. 525-33.
    Glynn RJ, Ridker PM, Goldhaber SZ, et al. Effect of low-dose aspirin on the occurrence of venous thromboembolism: a randomized trial. Ann Intern Med. 2007;147(8):525-33.
    Glynn, R. J., Ridker, P. M., Goldhaber, S. Z., & Buring, J. E. (2007). Effect of low-dose aspirin on the occurrence of venous thromboembolism: a randomized trial. Annals of Internal Medicine, 147(8), pp. 525-33.
    Glynn RJ, et al. Effect of Low-dose Aspirin On the Occurrence of Venous Thromboembolism: a Randomized Trial. Ann Intern Med. 2007 Oct 16;147(8):525-33. PubMed PMID: 17938390.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of low-dose aspirin on the occurrence of venous thromboembolism: a randomized trial. AU - Glynn,Robert J, AU - Ridker,Paul M, AU - Goldhaber,Samuel Z, AU - Buring,Julie E, PY - 2007/10/17/pubmed PY - 2007/11/9/medline PY - 2007/10/17/entrez SP - 525 EP - 33 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 147 IS - 8 N2 - BACKGROUND: Short-term aspirin therapy can lower the risk for venous thromboembolism (VTE) in high-risk patients, but whether the long-term use of low-dose aspirin reduces risk in healthy adults is uncertain. OBJECTIVE: To test the efficacy of long-term aspirin therapy for preventing VTE. DESIGN: Secondary analysis of a 10-year randomized, double-blind, placebo-controlled trial. SETTING: U.S. female health care professionals in the Women's Health Study. PARTICIPANTS: 39,876 initially healthy women age 45 years or older (26,779 gave blood samples that were evaluated for factor V Leiden, G20210A prothrombin, and MTHFR 677C>T polymorphisms). MEASUREMENTS: Documented VTE (deep venous thrombosis or pulmonary embolism) and unprovoked VTE (no recent surgery, trauma, or cancer diagnosis) were prospectively evaluated, secondary end points. INTERVENTION: Aspirin, 100 mg, or placebo on alternate days. RESULTS: Venous thromboembolism occurred in 482 women during follow-up, an incidence higher than that of myocardial infarction and nearly equal to that of stroke. The incidence of VTE (per 1000 person-years) was 1.18 among women randomly assigned to active aspirin, compared with 1.25 among women randomly assigned to placebo (relative hazard, 0.95 [95% CI, 0.79 to 1.13]; rate difference, -0.06 [CI, -0.28 to 0.16]). For unprovoked VTE, the relative hazard was 0.90 (CI, 0.70 to 1.16) and the rate difference was -0.06 (CI, -0.21 to 0.10). Relative hazards associated with aspirin use in higher-risk subgroups were 0.83 (CI, 0.50 to 1.39) among women with either factor V Leiden or the prothrombin mutation and 1.36 (CI, 0.77 to 2.41) among those with a history of VTE. LIMITATION: Venous thromboembolism was a secondary end point in the Women's Health Study. CONCLUSION: These data suggest that long-term, low-dose aspirin treatment has little effect on the prevention of VTE in initially healthy women. ClinicalTrials.gov registration number: NCT00000479. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/17938390/Effect_of_low_dose_aspirin_on_the_occurrence_of_venous_thromboembolism:_a_randomized_trial_ L2 - https://www.annals.org/article.aspx?volume=147&issue=8&page=525 DB - PRIME DP - Unbound Medicine ER -