JAMA. Aspirin Use in Adults: Cancer, All-Cause Mortality, and Harms: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Study Population: Approximately 164,000 subjects at varying risk for cardiovascular disease. Please enable it to take advantage of the complete set of features! The generic term for the brand name is acetylsalicylic acid (ASA). The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease. Agency for Healthcare Research and Quality (US). Researchers said the findings support a recent change to guidelines on low-dose aspirin: The blood thinner should now be reserved for people at high risk of heart attack or stroke. Eur Heart J. : 12(14)-EHC149-EF. Aspirin for the Primary Prevention of Cardiovascular Events: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. This means that the effectiveness of oral anticoagulants is roughly the same as aspirin in this group of patients. A Benefit and Harm Analysis. You'll find all of our therapeutic/number needed to treat reviews, arranged by medical specialty, organ system, alphabetically, and by color rating. | The absolute stroke reduction was 2.3% per year with rivaroxaban plus aspirin (NNT= 43 for one year). Stegeman I, Bossuyt PM, Yu T, Boyd C, Puhan MA. The bulk of the evidence for this came from the second international study of … When we weighted outcomes equally in a sensitivity analysis, the harm from aspirin was greater compared with the main analysis because of greater relative weight for GI bleeds. Learn more about the effect of aspirin therapy given within 48 hours of acute ischemic stroke in reducing the risk of death, dependence, or recurrent stroke, and the chance of complete recovery. This study talks about the efficacy of oral anticoagulants when compared with aspirin. The first trial to demonstrate that aspirin could prevent a primary CV event was the Physicians' Health Study. Mahmoud AN, Gad MM, Elgendy AY, Elgendy IY, Bavry AA. Show details . Dehmer SP, Maciosek MV, Flottemesch TJ, LaFrance AB, Whitlock EP. Prior work has described various quantitative approaches to the assessment of benefits and harms of medical interventions. Aspirin inhibits platelet aggregation which reduces clot formation. Bibbins-Domingo K. Aspirin Use for the Primary Prevention of Cardiovascular Disease and Colorectal Cancer: U.S. Preventative Service Task Force Recommendation Statement. There is debate across reviews about the definition of“primary prevention.” In the ETDRS study14 half of the patients had known CVD, and all patients in the POPADAD study15 and the AAA study16 had arterial disease. 1428. It is an … 2017;38:598-608. Aspirin increased the risk of major bleeding by 0.077% ( [NNH] = 1,295), with the most common bleeds being extracranial and GI. Therapy (NNT) Reviews. The older USPTF analysis and the newer review by Mahmoud et al. We compared the number-needed-to-treat (NNT) and number-needed-to-harm (NNH) approach and the Gail/National Cancer Institute (NCI) approach for assessing the benefits (prevention of myocardial infarction [MI] and ischemic stroke) and harms (excess of hemorrhagic stroke and major gastrointestinal [GI] bleeds) of aspirin for primary prevention of cardiovascular events. We based our main analyses for these two approaches on the treatment effects from a meta-analysis of large primary prevention trials, and the incidence rates from observational studies. USA.gov. The average event rate per year is calculated as the number of events divided by the patient-years at risk. … This site needs JavaScript to work properly. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Nov. Report No. Thrombolytics for stroke thennt thenntthennt. Caveats: The older USPSTF report has limitations. The interventions included sulindac, celecoxib, or aspirin (ASA). The original manuscript was published in Academic Emergency Medicine as part of the partnership between TheNNT.com and AEM. exp date isn't null, but text field is. Categories. 68-94 View As: NNT % Details for this Review; Source: ISIS2: Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17187 cases of suspected acute myocardial infarction. Posted By. For the end point of myocardial infarction, stroke, revascularization, or death, the 5-year NNT within JUPITER was 20 (95% CI, 14 to 34). Vandvik P, Lincoff A, Gore J, Gutterman D, Sonnenberg F, Alonso-Coello P, et al. Author: Kristopher Roach, MD; Michael Ritchie, MD; Shahriar Zehtabchi, MDSupervising Editor: Kabir Yadav, MD. Conclusion: Abstract Background Combination antiplatelet therapy with clopidogrel and aspirin may reduce the rate of recurrent stroke during the first 3 months after a … Unfortunately, that calculator substantially overestimates risk (by anywhere from 20-100% or more).11,s 12, 13 Given the razor-thin benefit margins found, any overestimate of baseline risk would convert the finding of overall benefit to a finding of overall harm. study may explain why Zheng et al. The American College of Obstetricians and Gynecologists issued the Hypertension in Pregnancy Task Force Report recommending daily low-dose aspirin beginning in the late first trimester for women with a history of early-onset preeclampsia and preterm delivery at less than … Aspirin or other antiplatelet vs placebo or no treatment. When the NNT and NNH values were different, to be conservative, we reported the higher NNT value and the lower NNH value. | The varying inclusion of the three studies who enrolled patients with apparent CVD resulted in 96% overlap between the Mahmoud et al. We focused on observational studies that were most applicable to our target population—aged 50 to 84 years, living in the United States without evidence of cardiovascular disease or stroke. While overall benefit may be true in secondary prevention in high-risk patients, results from these primary prevention reviews are uniform in the benefits not outweighing the harms. Aspirin was discovered in 1897 and marketed initially as an analgesic. NET BENEFIT AND NNT FOR ASPIRIN RELATED TO CORONARY HEART DISEASE EVENT RISK. 2019;321:277–87. JAMA 1992;268:1292-300. So we have to take aspirin into account when interpreting the NNT … Methods: Researchers rarely use these approaches in the context of a systematic review. What is the role of aspirin for primary ASCVD prevention? NEJM. Results: The NNT and NNH for aspirin declined with increasing age because of the increase in baseline incidence rates for all outcomes across age categories as obtained from observational studies. Our objectives were to illustrate two quantitative approaches to assessing benefits and harms in the context of a systematic review, and to determine the methodological challenges of applying these approaches in a systematic review. 2018;392:1036-46. Aspirin NNT/NNH. 0.7% were helped by preventing a recurrent stroke at 30 days. The point estimates of the NNT are higher, and there is no overlap of the confidence intervals. Effects of aspirin on risks of vascular events and cancer according to bodyweight and dose: analysis of individual patient data from randomised trials. Available at: https://www.acc.org/latest-in-cardiology/articles/2014/08/25/14/48/strengths-and-limitations-of-the-ascvd-risk-score-and-what-should-go-in-the-risk-discussion. No, the statement should be: 1 in every 30 high-risk patients gets additional benefit from oral anticoagulants, compared with aspirin. Aspirin works to reduce events among patients who have a higher likelihood of having an event, and there remains an argument for aspirin in patients who are at exceptionally high risk but who have not yet had a heart attack or a stroke. This was true both overall (for CAC≥100, NNT 5 =140 versus NNH 5 =518) and within ASCVD risk strata. If you have guidelines, requests, or questions on a specific nnt evaluate, please send us a message and we’ll attempt to deal with it as soon as viable. 2012;141:e637s-e668s. Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, et al. By Shereen K. Lehman, DC, MS and James Lehman, DC THE NUMBER NEEDED TO TREAT NNT represents an estimate of the number of people who need to undergo the treatment of interest in order to prevent one additional adverse outcome from occurring. Tags. Whitlock EP, Williams SB, Burda BU, Feightner A, Beil T. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Sep. Report No. 4 Meta-analysis showed that aspirin reduced the risk of first CV event by about 12%, which was not as dramatic as the 22% reduction seen in secondary prevention. For this purpose, we summarize the 2015 US PreventiveServices Task Force report2 and two recent systematic reviews of aspirin for primary prevention.3, 4 The USPSTF report, published in 2016, was the definitive systematic review until three trials were published after its release. These benefits of aspirin were evident in just a few days, with little risk of bleeding in this short time. concluded “a high degree” of heterogeneity (I2=67%). Further concern regarding the USPTF report reliance on the AHA calculator to project a subgroup benefit is that coronary events occurred at less than a third the predicted rate in the ASPREE trial,7 and less than half predicted in the ARRIVE,5and ASCEND6 trials. | For persons with known CVD, the beneficial effect of aspirin use for preventing cardiovascular events outweighs the harmful side effects (e.g. By so doing, values of 5-year NNT within JUPITER could then be compared to 5-year NNT values obtained in prior statin trials in both primary and secondary prevention, as well as 5-year NNT values deriving from other prevention settings including the treatment of hypertension among middle aged men and women as well as the prophylactic use of aspirin. For example, in men aged 45–54, the NNT was 1,786 person-years of treatment to prevent one MI, and the NNH was 1,344 person-years of treatment to induce one major GI bleed (which corresponds to 5.6 MI prevented and 57.4 GI bleeds induced if 1,000 people are treated with aspirin for 10 years, compared with no aspirin use). National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error, Evaluation of the Benefits and Harms of Aspirin for Primary Prevention of Cardiovascular Events: A Comparison of Quantitative Approaches [Internet]. Ann Intern Med. NNT Annualised NNT; Serious vascular event. Risk score overestimation: the impact of individual cardiovascular risk factors and preventive therapies on the performance of the American Heart Association-American College of Cardiology-Atherosclerotic Cardiovascular Disease risk score in a modern multi-ethnic cohort. prevention significantly reduces the risk of total CVD events (Number need to treat (NNT) 120 over 6 years), largely through its effect on nonfatal myocardial infarction (NNT 162 over 6 years). Less clear are differences in the two new meta-analyses regarding the heterogeneity of the trials. Print. The benefit of aspirin on reducing vascular events did not outweigh the increased risk for serious bleeding in this new large primary prevention trial in diabetic patients. American College of Cardiology. At a coronary heart disease event risk of 0.5%/year, the NNT … 3.3% = 1/30) [1]. Number Needed to Treat (NNT) represents the number of patients over a given time period that one would need to treat to achieve one additional study endpoint. We aimed to cast more light on aspirin's role for the primary prevention of CVD. For example, in men aged 45–54, the NNT was 1,786 person-years of treatment to prevent one MI, and the NNH was 1,344 person-years of treatment to induce one major GI bleed (which corresponds to 5.6 MI prevented and 57.4 GI bleeds induced if 1,000 people are treated with aspirin … The NNT for aspirin to prevent cardiovascular calamities is even higher. the effect of aspirin on vascular and non-vascular outcomes5 concluded that aspirin in primary prevention significantly reduces the risk of total CVD events (Number need to treat (NNT) 120 over 6 years), largely through its effect on nonfatal myocardial infarction (NNT 162 over 6 years). 1 in 79 were helped (death, dependency avoided) 1 in 143 were helped (prevented repeat stroke) The ARR is thus the difference between the aspirin rate and the clopidogrel rate. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data … McNeil JJ, Woods RL, Nelson MR, Reid CM, Kirpach B, Wolfe R, et al. By so doing, values of 5-year NNT within JUPITER could then be compared to 5-year NNT values obtained in prior statin trials in both primary and secondary prevention, as well as 5-year NNT values deriving from other prevention settings including the treatment of hypertension among middle aged men and women as well as the prophylactic use of aspirin. 98% saw no benefit. The NNT 5 was also greater than or similar to the NNH 5 among estimated ASCVD risk strata. Results: Most studies involved aspirin doses between 75 mg and 100 mg daily. Primary and secondary prevention of cardiovascular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Antiplatelet agents probably marginally increase placental abruption, but the quality of the evidence was downgraded to moderate due to low event … Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta -analysis and trial sequential analysis of randomized controlled trials. Conclusions—Absolute risk reductions and consequent NNT values associated with statin therapy among those with elevated high-sensitivity C-reactive protein and low low-density lipoprotein cholesterol are comparable if not superior Ticagrelor added to aspirin resulted in a significant 27% relative risk reduction of stroke or death as compared to placebo added to aspirin, with an NNT of only 34 (95% CI, 19–171) as compared to a NNT of 92 (95% CI, 51–509) in the overall THALES population. More recently there has been interest in the use of aspirin for primary and secondary prevention of cancer. Lloyd-Jones DM. Some patients may value avoiding nonfatal heart attacks or possibly avoiding ischemic strokes as being worth the increased risk of major bleeding. Assuming an 18% reduction in CHD, for individuals with CAC≥100 in this sample to have a net harm with aspirin (NNT 5 < NNH 5), the absolute bleeding rate would have to increase by a rate of 0.9% over 5 years with aspirin use, a 3.5-fold higher rate of major bleeding compared with rate seen in the meta-analysis used for this study. did not find that aspirin prevented ischemic stroke, combined fatal and nonfatal.2, 3 Only the systematic review by Zheng et al.4 showed a small reduction in risk of ischemic stroke in patients allocated to the aspirin group, with an NNT value of 625 (Table 2). The overall NNT 5 with aspirin to prevent 1 cardiovascular disease event was 476 and the NNH 5 was 355. (Defined as MI, stroke or vascular death). found a statistically significant small stroke prevention benefit, while Mahmoud et al. 1988 Aug 13;2(8607):349-60. For the most part, the reported number-needed-to-treat (NNT) values and number-needed-to-harm (NNH) values were similar between the two reviews (Table 2). Aspirin reduced major adverse CV events (MACE) by 0.052% (NNT = 1,908) and MI by 0.041% (NNT = 2,452). Therapy (NNT) Reviews by Date December 2020. Pooled comparison of 400 mg ibuprofen over 200 mg was statistically superior, with an NNT … These sources weighted major stroke nearly twice as much as MI and nearly eight times as much as major GI bleeds. Aspirin for Primary Prevention of Cardiovascular Disease and Cancer. Incidence of the composite CV outcome was 57 per 10,000 person-years for aspirin users and 61 per 10,000 person-years for non–aspirin users. If faulty calculators and conservative gestalt lead to overestimation of risk, and clinicians wrongly believe higher risk means greater benefit from aspirin, overall harm due to aspirin prescribing for primary prevention is probably widespread. 2018;392:387-99. These differences in the results could be from existing heterogeneity among different trials that were included (11 trials in the analysis by Mahmoud et al. NEJM. Combining them with simple analgesics improves analgesic efficacy. : 13-05193-EF-1. CONCLUSION: The NICE and USPSTF guidelines offer a simple and specific approach for recommending aspirin prophylaxis for women at high-risk of pre-eclampsia where more advanced screening methods are not available. There was no benefit on CV death or on cancer deaths or on all-cause mortality. Background and Aims: Aspirin leads to substantial benefits for the secondary prevention of cardiovascular disease (CVD). : 15-05229-EF-1. Main outcome measures—Benefit from aspirin, expressed as reduction in cardiovascular events, myocardial infarctions, strokes, and total mortality; harm caused by aspirin in relation to significant bleeds and major haemorrhages. The title bar is color-coded with our overall recommendation. Conversely, CAC≥100 and CAC≥400 identified subgroups in which NNT 5 was lower than NNH 5. Clipboard, Search History, and several other advanced features are temporarily unavailable. Ann Intern Med. Over the years it has been used for other purposes including the prevention of both arterial and venous thrombosis, and as an anti-inflammatory drug. A sensitivity analysis that considered different baseline incidence rates from randomized trials showed a much higher NNH for GI bleeds because the baseline incidence rate of that outcome was 2–3 times lower than in observational studies. 2016;164:836-845. Aspirin significantly reduced the risk of serious vascular events, including death. Muntner P, Colantonio LD, Cushman M, Goff DC Jr, Howard G, Howard VJ, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Aspirin is a trademark owned by Bayer AG, a German pharmaceutical company. If you have suggestions, requests, or questions about a particular NNT review, please send us a message and we’ll try to address it as soon as possible. 2015. From the combined results of three trials, significantly fewer subjects in the low dose ASA group developed recurrent sporadic CRAs [RR 0.77 (95% CI 0.61, 0.96), (NNT 12.5 (95% CI 7.7, 25)] after one to three years. Effect of aspirin on disability-free survival in the healthy elderly (ASPREE). ETDRS Investigators. We considered Black (Harmful) but recognize there may be subgroups studies that will identify patients who can benefit. The summary table above of benefits and harms are derived from the two most recent meta-analyses by Mahmoud et al.3 and Zheng et al.4 because the USPTF report does not include the most recent trials. We obtained relative weights denoting the relative importance of different outcomes (required by the Gail/NCI approach) from literature sources. Median follow-up was 5 years. Source: Bibbins-Domingo K. Aspirin Use for the Primary Prevention of Cardiovascular Disease and Colorectal Cancer: U.S. Preventative Service Task Force Recommendation Statement. Methods: Databases were searched for clinical trials comparing aspirin vs. no aspiri … review (157000 subjects) and Zheng et al. 29 -31 months 28-40. Ann Intern Med. Precise inflammatory conditions in which aspirin is. The benefit of aspirin on reducing vascular events did not outweigh the increased risk for serious bleeding in this new large primary prevention trial in diabetic patients. Mean 5.8 years 246. These patients constitute less than 9000 subjects (5%) of the total patients analyzed. review (164000 subjects). 2019;321:277–87. The RRR in our model is not specifically related to a particular time point. Ann Intern Med. When we weighted stroke as a very important outcome (weight of 1), MI as an important outcome (weight of 0.5), and GI bleed as an unimportant outcome (weight of 0), aspirin was associated with net benefit for all sex and age categories. Would you like email updates of new search results? As an example, in the PROSEVA trial of patients with severe ARDS, prone positioning decreased 28-day all-cause mortality compared to supine positioning (16% vs. 32.8%) with a NNT of 6. The NNT and NNH for aspirin declined with increasing age because of the increase in baseline incidence rates for all outcomes across age categories as obtained from observational studies. For the end point of myocardial infarction, stroke, revascularization, or death, the 5-year NNT within JUPITER was 20 (95% CI, 14 to 34). It is part of a group of drugs called salicylates, that work by stopping the production of prostaglandins, active lipid compounds in the human body which cause inflammation. BMJ 2008;337:a184. did not (Table 2). Quantitative approaches can be particularly valuable in demonstrating how the expected balance of benefits and harms depends on assumptions about the relative weights of different outcomes. Fowkes FG, Price JF, Stewart MC, Butcher I, Leng GC, Pell AC, et al. Strengths and Limitations of the ASCVD Risk Score and What should Go in the Risk Discussion. Eur Heart J. Major Bleeding: NIH 2015 Jul 7;10(7):e0127194. Zheng et al. (5-year NNT, 40 to 70), for antihypertensive therapy (5-year NNT, 80 to 160), or for aspirin (5-year NNT, 300). Aspirin has been used as a pain reliever for more than 100 years. The NNS was 2336 and NNT 71. Association of Aspirin Use for Primary Prevention With Cardiovascular Events and Bleeding Events: A Systematic Review and Meta-analysis. Moreover, the model is out of date as three new large randomized controlled trials have been published since its release. We have illustrated that quantitative approaches are feasible in a specific decisionmaking context—using data from a systematic review of aspirin for primary prevention. Table 4 sets out benefit (number of myocardial infarctions prevented and NNT) net of bleeding complications of different severity, assuming that 100 people are treated for five years, for coronary heart disease event risks of 0.5%, 1.0%, and 1.5% a year. The USPSTF approach demonstrated similar performance. Background: (5-year NNT, 40 to 70), for antihypertensive therapy (5-year NNT, 80 to 160), or for aspirin (5-year NNT, 300). From the combined results of three trials, significantly fewer subjects in the low dose ASA group developed recurrent sporadic CRAs [RR 0.77 (95% CI 0.61, 0.96), (NNT 12.5 (95% CI 7.7, 25)] after one to three years. 2018;379:1499-1508. Benefits in NNT. The finding of overall benefit for 50-59 year old patients is a computer projection based upon a statistical model.10 The model uses data from subgroups across several trials, and applies the benefits found with aspirin to a hypothetical person - in this case, a 50-59 year-old American male - with a baseline cardiovascular risk estimated using the AHA risk calculator. Of vascular events, hemorrhagic strokes whom aspirin would likely yield net harm ( NNT ) for attack!, Gorelick PB, et al RRR in our model is out of date as new. Group of patients the brand name is acetylsalicylic acid ( ASA ) as major bleed! Attack, stroke, measured over 5-7 years aspirin or other antiplatelet vs placebo or no treatment for three of. 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