This statement summarizes the current U.S. Preventive Services Task Force (USPSTF) recommendation on aspirin for the primary prevention of cardiovascular events and the supporting scientific evidence, and updates the 1995 recommendation contained in the Guide to Clinical Preventive Services, Second Edition1.
Summary of Recommendation
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Clinical Considerations
Scientific Evidence
Recommendations of Others
References and Notes
Members of the Task Force
Contact the Task Force
Available Products
Task Force Ratings Strength of Recommendations and Quality of Evidence |
Cardiovascular disease, including ischemic coronary heart disease, stroke, and peripheral vascular disease, is the leading cause of death in the United States.3 Yearly, over 1 million Americans experience new or recurrent myocardial infarction or fatal coronary heart disease. Most events occur in older people and those with recognized risk factors for cardiovascular disease, including high cholesterol, high blood pressure, diabetes, or a history of smoking.
The early-documented and clear success of aspirin in preventing further clinical disease in some patients with known heart disease (secondary prevention) raised interest in aspirin as a potential primary preventive intervention in men and women without known heart disease.4 Two early randomized trials of aspirin had conflicting results, however, and lacked sufficient power to estimate major harms, such as gastrointestinal bleeding and hemorrhagic stroke.5,6 Thus, the role of aspirin in primary prevention has remained controversial. The new USPSTF recommendation incorporates additional data from three recent trials and provides more reliable estimates of both benefits and harms of aspirin in patients without known heart disease.
Five trials have examined the effects of daily or every-other-day aspirin for the primary prevention of cardiovascular events over periods of 4 to 7 years.5-9 Most participants were men older than 50 years. Meta-analysis of pooled data from all of the studies showed that aspirin therapy reduced the risk for CHD by 28 percent (summary odds ratio [OR], 0.72; 95 percent CI, 0.60 to 0.87). Summary estimates showed no significant effects of aspirin on total mortality (OR, 0.93; 95 percent CI, 0.84 to 1.02) and stroke (OR, 1.02; 95 percent CI, 0.85 to 1.23).
These five primary prevention trials, and a larger number of randomized controlled trials (RCTs) of secondary prevention that enrolled patients with heart disease or stroke, demonstrate that aspirin increases rates of gastrointestinal bleeding. Estimated rates of major gastrointestinal bleeding episodes are approximately 2 to 4 per 1,000 middle-aged individuals (4 to 12 for older individuals) given aspirin for 5 years.10-12
These controlled trials in primary and secondary prevention settings also suggest that aspirin increases rates of hemorrhagic strokes by a small amount (0-2 per 1,000 individuals given aspirin for 5 years).5-7 Such estimates are less reliable than those of gastrointestinal bleeding because few strokes were reported in the trials.
In 1994, the Canadian Task Force on Preventive Health Care concluded that the evidence was not strong enough to recommend for or against use of aspirin for primary prevention of heart disease in men or women and recommended that physicians and patients balance the reduced rate of nonfatal myocardial infarction against potential adverse effects.13 In 2000, the American Diabetes Association recommended that clinicians consider aspirin for primary prevention of heart disease in diabetic patients who are older than 30 years or have risk factors for cardiovascular disease and no contraindications to aspirin therapy.14 In 1997, the American Heart Association concluded that aspirin may be warranted for patients at high risk of myocardial infarction but that health care providers must consider a patient's particular cardiovascular risk profile, the demonstrated benefits of aspirin on reducing risk for a first myocardial infarction, and known as well an unknown side effects of aspirin.15
In 1998, the European Society of Cardiology recommended low-dose aspirin (75 mg) for patients with well-controlled hypertension and men at "particularly" high risk for coronary heart disease, but not for all individuals at high risk.16
This document is in the public domain within the United States. For information on reprinting, contact Randie Siegel, Director, Office of Communications and Knowledge Transfer, Agency for Healthcare Research and Quality, Suite 501, 2101 East Jefferson Street, Rockville, MD 20852. Requests for linking or to incorporate content in electronic resources should be sent to: info@ahrq.gov.
Source: U.S. Preventive Services Task Force. Aspirin for the primary prevention of cardiovascular events: recommendations and rationale. Ann Int Med 2002;136(2):157-60.
Members of the U.S. Preventive Services Task Force are Alfred O. Berg, M.D., M.P.H., Chair, USPSTF (Professor and Chair, Department of Family Medicine, University of Washington, Seattle, WA); Janet D. Allan, Ph.D., R.N., C.S., Vice-chair, USPSTF (Dean and Professor, School of Nursing, University of Texas Health Science Center, San Antonio, TX); Paul S. Frame, M.D. (Tri-County Family Medicine, Cohocton, NY, and Clinical Professor of Family Medicine, University of Rochester, Rochester, NY); Charles J. Homer, M.D., M.P.H. (Executive Director, National Initiative for Children's Healthcare Quality, Boston, MA); Mark S. Johnson, M.D., M.P.H. (Associate Professor of Clinical Family Medicine and Chairman Department of Family Medicine, University of Medicine and Dentistry of New Jersey-New Jersey Medical School, Newark, NJ); Jonathan D. Klein, M.D., M.P.H. (Associate Professor of Pediatrics and of Community and Preventive Medicine, University of Rochester School of Medicine, Rochester, NY), Tracy A. Lieu, M.D., M.P.H. (Associate Professor, Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School, Boston, MA); Cynthia D. Mulrow, M.D., M.Sc. (Professor of Medicine, University of Texas Health Science Center, Audie L. Murphy Memorial Veterans Hospital, San Antonio, TX); C. Tracy Orleans, Ph.D. (Senior Scientist, The Robert Wood Johnson Foundation, Princeton, NJ); Jeffrey F. Peipert, M.D., M.P.H (Director of Research, Women and Infants' Hospital, Providence, RI); Nola J. Pender, Ph.D., R.N. (Professor and Associate Dean for Research, School of Nursing, University of Michigan, Ann Arbor, MI); Albert L. Siu, M.D., M.S.P.H (Professor of Medicine, Chief of Division of General Internal Medicine, and Medical Director of the Primary Care and Medical Services Care Center, Mount Sinai School of Medicine and The Mount Sinai Medical Center, New York, NY); Steven M. Teutsch, M.D., M.P.H. (Senior Director, Outcomes Research and Management, Merck & Company, Inc., West Point, PA); Carolyn Westhoff, M.D., M.Sc. (Associate Professor of Obstetrics, Gynecology and Public Health, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY); and Steven H. Woolf, M.D., M.P.H. (Professor of Family Medicine, Department of Family Practice, Medical College of Virginia, Fairfax, VA).
Address correspondence to: Chair, U.S. Preventive Services Task Force; c/o Project Director, USPSTF; 540 Gaither Road; Rockville, MD 20850; E-mail: uspstf@ahrq.gov.
This recommendation and rationale statement, plus complete information on which this statement is based, including evidence tables and references, are available on the USPSTF Web site at http://www.preventiveservices.ahrq.gov.
Recommendations made by the USPSTF are independent of the U.S. Government. They should not be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.
Current as of January 2002
Internet Citation:
U.S. Preventive Services Task Force. Aspirin for the Primary Prevention of Cardiovascular Events: Recommendations and Rationale. January 2002. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/3rduspstf/aspirin/asprr.htm
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