Draft Recommendation Statement
Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication
October 12, 2021
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
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- Update in Progress for Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication
|Adults ages 40 to 59 years with a 10% or greater 10-year cardiovascular disease (CVD) risk||The decision to initiate low-dose aspirin use for the primary prevention of CVD in adults ages 40 to 59 years who have a 10% or greater 10-year CVD risk should be an individual one. Evidence indicates that the net benefit of aspirin use in this group is small. Persons who are not at increased risk for bleeding and are willing to take low-dose aspirin daily are more likely to benefit.||C|
|Adults age 60 years or older||The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults age 60 years or older.||D|
- Aspirin Use to Prevent Cardiovascular Disease (Consumer Guide): Draft Recommendation | Link to File New Resource for Clinicians and Patients
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The USPSTF concludes with moderate certainty that aspirin use for the primary prevention of CVD events in adults ages 40 to 59 years who have a 10% or greater 10-year CVD risk has a small net benefit.
The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.
Patient Population Under Consideration
This recommendation applies to adults age 40 years or older without known CVD (including history of myocardial infarction or stroke) who are not at increased risk for bleeding (e.g., no history of gastrointestinal ulcers, recent bleeding, or other medical conditions, or use of medications that increase bleeding risk). In this Recommendation Statement, CVD risk and the net benefits of aspirin use are discussed using the terms “men” and “women,” although it is likely that CVD risk and net benefit estimates are driven by sex (i.e., male/female) rather than gender identity.
Assessment of Risk
Age is one of the strongest risk factors for CVD. Men carry a higher overall burden of CVD, although women experience higher mortality from certain cardiovascular events, such as stroke. Men tend to experience CVD events earlier in life compared with women. The burden of CVD also differs by race and ethnicity. Among both sexes, Black Americans have the highest prevalence of CVD.1
The USPSTF recommends using the American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equations to estimate 10-year risk of CVD. The ACC/AHA risk calculator is, to date, the only U.S.-based CVD risk prediction tool that has published external validation studies in other U.S.-based populations.3 The calculator has sex- and race-specific equations, including the risk factors of age, cholesterol levels, systolic blood pressure level, antihypertension treatment, presence of diabetes, and smoking status, and focuses on hard clinical outcomes (heart attack and death from coronary heart disease; ischemic stroke and stroke-related death) as the outcomes of interest. It is important to note that the 10-year CVD event risk estimated by the ACC/AHA risk calculator is heavily influenced by increasing age. The risk prediction equations generally show higher risk for African American persons than White persons.3 The USPSTF recognizes that race is a social construct, and it is an imperfect proxy for social determinants of health and the effects of structural racism. Concerns about calibration exist, with many external validation studies showing overprediction in broad populations (men and women across racial and ethnic groups).4-6 Limited evidence also suggests underprediction in disadvantaged communities7,8 that could lead to underutilization of preventive therapies.
The risk for gastrointestinal bleeding, intracranial hemorrhage, and hemorrhagic stroke, with or without aspirin use, increases with older age. Other risk factors include male sex, diabetes, and a history of gastrointestinal issues (such as peptic ulcer disease), liver disease, smoking, and elevated blood pressure. Certain medications, including nonsteroidal anti-inflammatory drugs, steroids, and anticoagulants, increase the risk of bleeding.9-12 These risk factors should be considered in the overall decision about whether to start or continue aspirin therapy.
Treatment or Intervention
Aspirin’s benefits for CVD prevention appear similar for a low dose (≤100 mg/d) and all doses that have been studied in CVD prevention trials (50 to 500 mg/d).13 A pragmatic approach would be to use 81 mg/d, which is the most commonly prescribed dose in the United States.
As discussed above, because risk prediction using the ACC/AHA Pooled Cohort Equations is imperfect at the individual level, the USPSTF suggests using its risk estimates as a starting point to discuss with appropriate candidates their desire for daily aspirin use. The benefits of initiating aspirin use are greater for individuals at higher risk for CVD events (e.g., those with >15% or >20% 10-year CVD risk).
Decisions about initiating aspirin use should be based on shared decision making between clinicians and patients about the potential benefits and harms. Persons who place a higher value on the potential benefits than the potential harms may choose to initiate low-dose aspirin use. Persons who place a higher value on the potential harms or on the burden of taking a daily preventive medication than the potential benefits may choose not to initiate low-dose aspirin use.
Annual bleeding events in individuals without risk factors for increased bleeding (e.g., history of gastrointestinal bleeding risk, history of peptic ulcer disease, or use of nonsteroidal anti-inflammatory drugs or corticosteroids) are rare, but risk for bleeding increases modestly with advancing age.11 For persons who have initiated aspirin use, the net benefits continue to accrue over time in the absence of a bleeding event. The net benefits, however, become smaller with advancing age because of an increased risk for bleeding, so modeling data suggest that it may be reasonable to consider stopping aspirin use around age 75 years.
Additional Tools and Resources
Million Hearts 2022 is a national initiative to prevent 1 million heart attacks and strokes within 5 years. It focuses on implementing a small set of evidence-based priorities and targets that can improve cardiovascular health for all and is available at https://millionhearts.hhs.gov/.
The Centers for Disease Control and Prevention have resources related to risk of heart disease and the prevention of heart disease for patients and health professionals at https://www.cdc.gov/heartdisease/index.htm.
The National Heart, Lung, and Blood Institute has patient resources related to coronary heart disease at https://www.nhlbi.nih.gov/health-topics/coronary-heart-disease.
Other Related USPSTF Recommendations
The USPSTF has made several other recommendations on CVD prevention, including statin use to prevent CVD,14 smoking cessation,15 counseling to promote a healthful diet and physical activity in persons with and without cardiovascular risk factors,16, 17 interventions to prevent obesity-related morbidity and mortality,18 as well as screening for high blood pressure19 and diabetes.20
When final, this recommendation will replace the 2016 USPSTF recommendation on aspirin use to prevent CVD and colorectal cancer (CRC).21 In 2016, the USPSTF recommended initiating low-dose aspirin use for the primary prevention of CVD and CRC in adults ages 50 to 59 years who have a 10% or greater 10-year CVD risk, are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years, and that the decision to initiate low-dose aspirin use in adults ages 60 to 69 years who have a 10% or greater 10-year CVD risk should be an individual one. The USPSTF found that the evidence was insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of CVD and CRC in adults younger than age 50 years or adults age 70 years or older.
For the current draft recommendation, the USPSTF has changed the age ranges and grades of its recommendation on aspirin use. The USPSTF recommends that the decision to initiate low-dose aspirin use for the primary prevention of CVD in adults ages 40 to 59 years who have a 10% or greater 10-year CVD risk should be an individual one, and recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults age 60 years or older. Based on new analyses of the evidence from primary CVD prevention populations,13 longer-term followup data from the Women’s Health Study (WHS) (JE Buring, personal communication, November 23, 2020), and new trial evidence,22 the USPSTF concluded that the evidence is inadequate that low-dose aspirin use reduces CRC incidence or mortality.
Scope of Review
To update its 2016 recommendation, the USPSTF commissioned a systematic review on the effectiveness of aspirin to reduce the risk of CVD events (myocardial infarction and stroke), cardiovascular mortality, and all-cause mortality in persons without a history of CVD. The systematic review also investigated the effect of aspirin use on CRC incidence and mortality in primary CVD prevention populations, as well as the harms, particularly bleeding harms, associated with aspirin use.13
In addition to the systematic evidence review, the USPSTF commissioned a microsimulation modeling study to assess the net balance of benefits and harms from aspirin use for primary prevention of CVD and CRC, stratified by age, sex, and CVD risk level. Modeling study parameter inputs were informed by the results of the systematic review, and the primary outcomes were net benefits expressed as quality-adjusted life-years and life-years.23
Benefits of Preventive Medication
The USPSTF found 13 randomized clinical trials (RCTs) that reported on the benefits of aspirin use for the primary prevention of cardiovascular morbidity and mortality.13 The total number of participants was 161,680, and most trials used low-dose aspirin of 100 mg/d or less or aspirin every other day. The 13 primary prevention trials included a balanced number of male and female participants and included a broad distribution of ages, with mean age ranging from 53 years in the Physicians' Health Study24 to 74 years in the Aspirin in Reducing Events in the Elderly (ASPREE) trial.22
This body of evidence shows that aspirin use for primary prevention of CVD is associated with a decreased risk of myocardial infarction and stroke but not cardiovascular mortality or all-cause mortality. Results are quite similar when including studies using all doses of aspirin compared with studies using low-dose aspirin.13 Since low-dose aspirin is most relevant to current practice, the analyses below report outcomes pooling studies of low-dose aspirin use. As noted below, pooled effect estimates of studies using low-dose aspirin were also used to inform the parameters and assumptions of the microsimulation modeling study.23
A pooled analysis of 11 trials (n=134,470) showed that low-dose aspirin use is associated with a statistically significant decreased risk of nonfatal myocardial infarction (Peto odds ratio [OR], 0.88 [95% CI, 0.80 to 0.96]). Similarly, a pooled analysis of five trials (n=54,947) demonstrated that low-dose aspirin use is associated with a statistically significant decreased risk of nonfatal ischemic stroke (Peto OR, 0.88 [95% CI, 0.78 to 1.00]; p<0.05). Fatal cardiovascular events were less common, and pooled analyses showed that low-dose aspirin use was not associated with a statistically significant effect on fatal myocardial infarction, fatal stroke, cardiovascular mortality, or all-cause mortality (at 3.6 to 10.1 years of followup).13 Although evidence does not suggest that the relative effect of aspirin on CVD outcomes is modified by baseline CVD risk, the absolute magnitude of the benefit is higher in persons at higher CVD risk.
New RCT data, as well as newly available information on the age distribution of participants in the WHS, show that almost 22,000 participants younger than age 50 years and more than 37,000 participants age 70 years or older were included in the CVD prevention trials. Most trials with age subanalyses did not find a statistically significant difference in the relative effect of aspirin on CVD outcomes by age.13 The USPSTF thus concluded that evidence on the benefits of aspirin on CVD outcomes was adequate for all groups, including adults ages 40 to 49 years and adults age 70 years or older.
The USPSTF found fewer studies reporting on the effects of aspirin use on CRC incidence or mortality. Four studies conducted in primary CVD prevention populations found no association between aspirin use and CRC incidence at up to approximately 10 years of followup.13 Only one trial, WHS (n=39,876), reported on the effect of low-dose aspirin use on CRC incidence beyond 10 years by including posttrial observational followup; it reported a lower incidence of CRC at 17.5 years of followup (Peto OR, 0.82 [95% CI, 0.69 to 0.98]) (JE Buring, personal communication, November 23, 2020).25 However, recently reported data from the WHS showed that this effect did not persist from 17.5 to 26 years of followup (JE Buring, personal communication, November 23, 2020). Two RCTs, ASPREE22 and WHS (JE Buring, personal communication, November 23, 2020), reported CRC mortality during the trial phase. ASPREE reported that aspirin use was associated with statistically significantly higher CRC mortality at 4.7 years of followup (Peto OR, 1.74 [95% CI, 1.02 to 2.95]), while the WHS did not find a statistically significant increase in CRC mortality at 10 years. Two trials of low-dose aspirin use reported reductions in CRC mortality when longer-term observational data was included in analyses. In the Thrombosis Prevention Trial26,27 (n=2,540), low-dose aspirin use was associated with a statistically significant lower risk of CRC mortality at 18.3 years of observational followup (Peto OR, 0.62, [95% CI, 0.41 to 0.94]), and WHS reported lower CRC mortality at 17.5 years of observational followup that was not statistically significant (Peto OR, 0.86 [95% CI, 0.64 to 1.16]) and was attenuated from 17.5 to 26 years of followup (JE Buring, personal communication, November 23, 2020).
The body of evidence on the effects of aspirin use on CRC incidence and mortality is limited by several factors. Overall, only a small number of trials reported on CRC outcomes. The ASPREE trial in older adults found aspirin use to be associated with an increased risk of CRC mortality.22 Longer-term followup data suggesting that aspirin use is associated with lower CRC risk is heavily weighted by one trial conducted in women only, and the evidence on CRC mortality is limited by few CRC deaths. Additionally, posttrial followup data may be subject to biases, and in some cases, CRC outcomes data were collected by outside investigators.13
Harms of Preventive Medication
The USPSTF reviewed 14 RCTs in CVD primary prevention populations that reported on the bleeding harms of aspirin. Studies reported a variety of outcomes, including total major bleeds (defined as a composite of intracranial hemorrhage, major gastrointestinal bleeding, or major bleeding from other sites), major gastrointestinal bleeds (defined as a gastrointestinal bleed that required a transfusion, hospital admission, or resulted in death), extracranial bleeds (defined as major bleeding that was not intracranial), hemorrhagic stroke, and intracranial bleeds (defined as hemorrhagic stroke, subarachnoid hemorrhage, and subdural hemorrhage).13
When looking at studies reporting on the harms of low-dose aspirin use (≤100 mg/d), which is most relevant to current practice, a pooled analysis of 10 trials (n=119,130) showed that aspirin use was associated with a 58% increase in major gastrointestinal bleeding (Peto OR, 1.58 [95% CI, 1.38 to 1.80]). A pooled analysis of 11 trials (N=134,470) showed an increase in intracranial bleeds in the aspirin group compared with the control group (Peto OR, 1.31 [95% CI, 1.11 to 1.54]). Low-dose aspirin use was not associated with a statistically significant increase in risk of fatal hemorrhagic stroke.13
Data suggest that the increased risk of bleeding associated with aspirin use occurs relatively quickly after initiating aspirin, and data do not suggest that aspirin has a differential relative bleeding risk based on age, sex, presence of diabetes, level of CVD risk, or race or ethnicity.13 Although the increase in relative risk does not appear to differ based on age, the absolute risk of bleeding, and thus the magnitude of bleeding harm, does increase with age, and more so in adults age 60 years or older. Because of the very small number of fatal gastrointestinal bleeding events in trials, and inconsistent reporting, it is uncertain whether aspirin use increases fatal gastrointestinal bleeding.13
Estimate of Magnitude of Net Benefit
The USPSTF commissioned a microsimulation model to estimate the magnitude of net benefit of low-dose aspirin use.23 The model incorporated findings from the systematic review to inform its parameters and assumptions, including that daily low-dose (≤100 mg/d) aspirin use reduces the risk of nonfatal myocardial infarction and nonfatal stroke, increases the risk of major gastrointestinal bleeding and intracranial hemorrhage and has no effect on the risk of CVD mortality. As there was insufficient evidence that aspirin use reduces CRC incidence, the modeling study base case assumed no effect of aspirin on CRC incidence.
Modeling outcomes were stratified by age, decade of aspirin initiation (40–49 years, 50–59 years, 60–69 years, and 70–79 years), sex, and baseline 10-year CVD risk level (5% to 20%). When combined with primary trial data and pooled analyses from the systematic evidence review, the model provides additional information to assess the balance of benefits and harms of aspirin use. The primary model outcomes were net quality-adjusted life-years and life-years gained or lost over a lifetime as a result of aspirin use. Also considered was the effect of stopping aspirin over 5-year age intervals from ages 65 to 85 years.23
Modeling data demonstrate that aspirin use in both men and women ages 40 to 59 years with 10% or greater 10-year CVD risk generally provides a modest net benefit in both quality-adjusted life-years and life-years gained. Initiation of aspirin use in persons ages 60 to 69 years results in quality-adjusted life-years gained that range from slightly negative to slightly positive depending on CVD risk level, and life-years gained are generally negative. In persons ages 70 to 79 years, initiation of aspirin use results in a loss of both quality-adjusted life-years and life-years at essentially all CVD risk levels modeled (i.e., up to 20% 10-year CVD risk) (Table 2).23 The USPSTF thus determined that aspirin use has a small net benefit in persons ages 40 to 59 years with 10% or greater 10-year CVD risk, and initiation of aspirin use has no net benefit in persons age 60 years or older.
When looking at net lifetime benefit of continuous aspirin use until stopping at age 65, 70, 75, 80, or 85 years, modeling data suggest that there is generally little incremental lifetime net benefit in continuing aspirin use beyond the age of 75 to 80 years.23 It is important to note that the net benefit of continuing aspirin use by a person in their 60s or 70s is not the same as the net benefit of initiating aspirin use by a person in their 60s or 70s. This is because, in part, of the fact that CVD risk is heavily influenced by age. Persons who meet the eligibility criteria for aspirin use at a younger age (i.e., ≥10% 10-year CVD risk in their 40s or 50s) typically have even higher CVD risk by their 60s or 70s compared with persons who first reach a 10% or greater 10-year CVD risk in their 60s or 70s, and may gain more benefit by continuing aspirin use than a person at lower risk might gain by initiating aspirin use.
How Does Evidence Fit With Biological Understanding?
Aspirin’s mechanism of action to promote CVD prevention is well known. At lower doses, aspirin is an irreversible cyclooxygenase (COX)-1 enzyme inhibitor. At higher doses, aspirin also inhibits COX-2. Aspirin reduces the risk for atherothrombosis through the inhibition of platelet function (through COX-1 inhibition) and has been used widely for the prevention of CVD events, particularly for secondary prevention.28 The COX-1 enzyme is also responsible for producing a variety of prostaglandins that protect the gastrointestinal mucosa.29 By inhibiting this enzyme, aspirin use can promote gastrointestinal bleeding.30
Research Needs and Gaps
More research is needed to evaluate the following.
- More research is needed on the gastrointestinal bleeding risk associated with aspirin use in populations representative of the U.S. primary CVD prevention population.
- More research is needed on improving the accuracy of CVD risk prediction in all racial and ethnic and socioeconomic groups.
- More research is needed to characterize the distribution of patient preferences across the spectrum of cardiovascular risk after patients are informed about the benefits and harms of aspirin.
- More research is needed on the effects of low-dose aspirin on CRC incidence and mortality over the long term (10 to 20 years and longer) in primary prevention populations, and in the context of current CRC screening practices.
The ACC/AHA recommends that low-dose aspirin use (75 to 100 mg/d) might be considered for the primary prevention of atherosclerotic CVD among select adults ages 40 to 70 years at higher CVD risk but not at increased risk of bleeding. Low-dose aspirin use is not recommended on a routine basis for primary prevention of CVD in adults older than age 70 years, or among adults of any age who are at increased risk of bleeding.31 The American Academy of Family Physicians supports the 2016 USPSTF recommendation on aspirin use.32
1. Virani SS, Alonso A, Aparicio HJ, et al. Heart disease and stroke statistics-2021 update: a report from the American Heart Association. Circulation. 2021;143(8):e254-e743.
2. U.S. Preventive Services Task Force. Procedure Manual. https://uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual. Accessed September 20, 2021.
3. Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:2935-59.
4. DeFilippis AP, Young R, Carrubba CJ, et al. An analysis of calibration and discrimination among multiple cardiovascular risk scores in a modern multiethnic cohort. Ann Intern Med. 2015;162(4):266-275.
5. Cook NR, Ridker PM. Calibration of the pooled cohort equations for atherosclerotic cardiovascular disease: an update. Ann Intern Med. 2016;165(11):786-794.
6. Rana JS, Tabada GH, Solomon MD, et al. Accuracy of the atherosclerotic cardiovascular risk equation in a large contemporary, multiethnic population. J Am Coll Cardiol. 2016;67(18):2118-2130.
7. Dalton JE, Perzynski AT, Zidar DA, et al. Accuracy of cardiovascular risk prediction varies by neighborhood socioeconomic position: a retrospective cohort study. Ann Intern Med. 2017;167(7):456-464.
8. Colantonio LD, Richman JS, Carson AP, et al. Performance of the atherosclerotic cardiovascular disease pooled cohort risk equations by social deprivation status. J Am Heart Assoc. 2017;6(3):e005676.
9. Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009;373:1849-60.
10. De Berardis G, Lucisano G, D'Ettorre A, et al. Association of aspirin use with major bleeding in patients with and without diabetes. JAMA. 2012;307:2286-94.
11. Selak V, Jackson R, Poppe K, et al. Predicting bleeding risk to guide aspirin use for the primary prevention of cardiovascular disease: a cohort study. Ann Intern Med. 2019;170(6):357-368.
12. de Groot NL, Hagenaars MP, Smeets HM, et al. Primary non-variceal upper gastrointestinal bleeding in NSAID and low-dose aspirin users: development and validation of risk scores for either medication in two large Dutch cohorts. J Gastroenterol. 2014;49(2):245-253.
13. Guirguis-Blake JM, Evans CV, Perdue LA, Bean SI, Senger CA. Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Evidence Synthesis No. 211. Rockville, MD: Agency for Healthcare Research and Quality; 2021. AHRQ publication no. 21-05283-EF-1.
14. US Preventive Services Task Force. Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(19):1997-2007.
15. US Preventive Services Task Force. Interventions for tobacco smoking cessation in adults, including pregnant persons: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(3):265-279.
16. US Preventive Services Task Force. Behavioral counseling interventions to promote a healthy diet and physical activity for cardiovascular disease prevention in adults with cardiovascular risk factors: US Preventive Services Task Force recommendation statement. JAMA. 2020;324(20):2069-2075.
17. US Preventive Services Task Force. Behavioral counseling to promote a healthful diet and physical activity for cardiovascular disease prevention in adults without cardiovascular risk factors: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(2):167-174.
18. US Preventive Services Task Force. Behavioral weight loss interventions to prevent obesity-related morbidity and mortality in adults: US Preventive Services Task Force recommendation statement. JAMA. 2018;320(11):1163-1171.
19. US Preventive Services Task Force. Screening for hypertension in adults: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2021;325(16):1650-1656.
20. US Preventive Services Task Force. Screening for prediabetes and type 2 diabetes: US Preventive Services Task Force recommendation statement. JAMA. 2021;326(8):736-743.
21. U.S. Preventive Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2016;164(12):836-845.
22. McNeil JJ, Wolfe R, Woods RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. New Engl J Med. 2018;379(16):1509-1518.
23. Dehmer SP, O’Keefe LR, Grossman ES, Maciosek MV. Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer: An Updated Decision Analysis for the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 2021. AHRQ publication no. 21-05283-EF-2.
24. Final report on the aspirin component of the ongoing Physicians' Health Study. Steering Committee of the Physicians' Health Study Research Group. N Engl J Med. 1989;321(3):129-35.
25. Cook NR, Lee IM, Zhang SM, Moorthy MV, Buring JE. Alternate-day, low-dose aspirin and cancer risk: long-term observational follow-up of a randomized trial. Ann Intern Med. 2013;159:77-85.
26. Thrombosis Prevention Trial: randomised trial of low-intensity oral anticoagulation with warfarin and low-dose aspirin in the primary prevention of ischaemic heart disease in men at increased risk. The Medical Research Council's General Practice Research Framework. Lancet. 1998;351(9098):233-241.
27. Rothwell PM, Wilson M, Elwin CE, et al. Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials. Lancet. 2010;376:1741-50.
28. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics-2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-e596.
29. Wallace JL. Prostaglandins, NSAIDs, and gastric mucosal protection: why doesn’t the stomach digest itself? Physiol Rev. 2008;88(4):1547-65.
30. Nemerovski CW, Salinitri FD, Morbitzer KA, Moser LR. Aspirin for primary prevention of cardiovascular disease events. Pharmacotherapy. 2012;32(11):1020-35.
31. Arnett DK, Blumenthal RS, Albert MA, et. al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646.
32. American Academy of Family Physicians. Clinical Preventive Service Recommendations: Aspirin Use to Prevent CVD and Colorectal Cancer. https://www.aafp.org/family-physician/patient-care/clinical-recommendations/all-clinical-recommendations/aspirin-use-prevention.html. Accessed September 9, 2021.
|Benefits of Aspirin Use||Adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults age 40 years or older who have no history of CVD but are at increased CVD risk. Evidence shows that the magnitude of benefit increases with increasing 10-year CVD risk, and that the magnitude of the lifetime benefits are greater when aspirin is initiated at a younger age.|
|Harms of Aspirin Use||Adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms are small overall but increase in older age groups, particularly in adults older than age 60 years.|
The USPSTF concludes with moderate certainty that aspirin use for the primary prevention of CVD events in adults ages 40 to 59 years who have a 10% or greater 10-year CVD risk has a small net benefit.The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.
Abbreviation: CVD=cardiovascular disease; USPSTF=U.S. Preventive Services Task Force.
|Age 40-49 y||Age 50-59 y||Age 60-69 y||Age 70-79y|
|Men, Net QALYs per 1,000 persons (95% CI)|
|7.5% 10-y CVD Risk||29.1 (22.3 to 36.0)||12.5 (6.5 to 18.5)||2.6 (-1.9 to 7.2)||-4.6 (-7.7 to -1.5)|
|10% 10-y CVD Risk||48.0 (40.6 to 55.5)*||18.0 (12.0 to 24.0)*||7.0 (2.2 to 11.8)||-1.1 (-4.4 to 2.2)|
|15% 10-y CVD Risk||52.3 (44.5 to 60.1)*||32.3 (26.2 to 38.5)*||8.3 (3.5 to 13.0)||-1.9 (-5.4 to 1.6)|
|20% 10-y CVD Risk||66.2 (58.2 to 74.1)*||48.4 (41.9 to 54.8)*||16.3 (11.4 to 21.1)||0.9 (-2.2 to 3.9)|
|Men, Net Life-Years per 1,000 persons (95% CI)|
|7.5% 10-y CVD Risk||16.2 (9.0 to 23.5)||0.4 (-6.1 to 6.9)||-6.7 (-11.5 to -1.9)||-10.1 (-13.4 to -6.8)|
|10% 10-y CVD Risk||36.1 (28.1 to 44.1)*||4.2 (-2.3 to 10.8)*||-3.0 (-8.0 to 1.9)||-6.9 (-10.5 to -3.4)|
|15% 10-y CVD Risk||37.9 (29.6 to 46.2)*||18.6 (11.7 to 25.4)*||-2.2 (-7.2 to 2.9)||-7.6 (-11.3 to -3.9)|
|20% 10-y CVD Risk||52.4 (43.9 to 60.9)*||33.9 (26.9 to 40.9)*||4.9 (-0.1 to 10.0)||-5.5 (-8.8 to -2.2)|
|Women, Net QALYs per 1,000 persons (95% CI)|
|7.5% 10-y CVD Risk||19.6 (12.3 to 26.8)||10.4 (3.9 to 16.9)||-5.8 (-10.9 to -0.7)||-6.4 (-10.0 to -2.8)|
|10% 10-y CVD Risk||35.1 (27.3 to 43.0)*||17.1 (10.2 to 24.0)*||2.3 (-2.7 to 7.4)||-6.1 (-9.4 to -2.7)|
|15% 10-y CVD Risk||43.0 (35.4 to 50.5)*||30.8 (24.5 to 37.2)*||11.6 (6.9 to 16.4)||-6.9 (-10.7 to -3.0)|
|20% 10-y CVD Risk||50.4 (42.3 to 58.5)*||41.6 (34.8 to 48.5)*||19.1 (14.2 to 24.1)||-4.4 (-8.1 to -0.7)|
|Women, Net Life-Years per 1,000 persons (95% CI)|
|7.5% 10-y CVD Risk||-2.6 (-10.0 to 4.7)||-11.8 (-18.7 to -5.0)||-20.2 (-25.6 to -14.9)||-15.4 (-19.0 to -11.8)|
|10% 10-y CVD Risk||11.4 (3.2 to 19.7)*||-6.5 (-13.6 to 0.7)*||-13.5 (-18.7 to -8.4)||-16.6 (-20.0 to -13.2)|
|15% 10-y CVD Risk||17.7 (9.8 to 25.5)*||7.5 (0.9 to 14.1)*||-7.2 (-12.3 to -2.1)||-17.9 (-21.9 to -14.0)|
|20% 10-y CVD Risk||24.2 (15.7 to 32.7)*||16.9 (9.7 to 24.1)*||-1.6 (-6.8 to 3.6)||-14.8 (-18.6 to -11.0)|