Aspirin in primary cardiovascular prevention: the two faces of the coin and the importance of the Number Needed to Treat: a systematic review and meta- analysis.
Aspirina en prevención cardiovascular primaria. Las dos caras de la moneda y la importancia del número necesario a tratar. Revisión sistemática y metanálisis.
Keywords:
aspirin, cardiovascular disease, primary prevention, bleeding risk, number needed to treat
Abstract
Aspirin has been an essential treatment for the primary prevention of cardiovascular diseases (CVD). Several randomized controlled studies do not support the routine use of aspirin, mainly due to its association with bleeding risk. This systematic review aims to advocate aspirin prescription based on the Number Needed to Treat (NNT) and the Number Needed to Harm (NNH). This combination provides a good measure of the effort to avoid an unfavorable outcome, weighed against possible associated risks. A search of randomized studies on aspirin treatment was conducted in two separate periods. Four studies from 1988-1998 and six from 2001-2018 were included in the analysis (157,060 participants). The primary endpoint was a composite outcome of Non-fatal Myocardial Infarction (NFMI), Non-fatal Ischemic Stroke (NFIS), and CV mortality. Major bleeding was a safety endpoint. We calculated the Absolute Risk Reduction (ARR%), NNT, and NNH, alongside the Relative Risk (RR) and 95% CI of each primary endpoint. The results of all included studies (10) showed a net benefit with aspirin treatment for NFMI (NNT= 259) and the composite outcome (NNT=292) with a significant relative risk reduction of 20% (p=0.003; I2 = 0%) and 10% (p<0.001; I2 = 0%), respectively. There was a relevant 60% increase in the bleeding risk (p<0.0001, NNH=208; I2 = 3%). The NNT and NNH may constitute measures of efficacy and risk in clinical shared decision-making. However, it is essential to consistently establish that patients’ benefit-risk should be individualized and not represent a clinical guide for everyone.
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References
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Collaborative Group of the Primary Prevention Project. Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomized trial in general practice. Lancet 2001;357:89- 95. https://doi. org/10.1016/S0140-6736(00)03539-X.
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Berger JS, Roncaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials. JAMA 2006;295:306– 313. doi: 10.1001/jama.295.3.306.
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Citrome L, Ketter TA. When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Int J Clin Pract 2013;67(5):407- 411. doi:10.1111/ijcp.12142.
Zheng SL, Roddick AJ. Association of as- pirin use for primary prevention with cardiovascular events and bleeding events: a systematic review and meta-analysis. JAMA 2019;22;321(3):277-287. doi: 1001/ jama.2018.20578.
Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: a collaborative meta-analysis of individual participant data from randomized. Lancet 2009; 373:1849–1860. doi: 1016/S0140-6736(09)60503-1.
Mahmoud AN, Gad MM, Elgendy AY, Elgendy IY, Bavry AA. Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta-analysis and trial sequential analysis of randomized controlled trials. Eur Heart J 2019;40(7):607- 617. doi:10.1093/eurheartj/ehy813.
Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, Hennekens CH, Buring JE. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med 2005;352(13):1293-1304. doi:10.1056/N EJMoa050613.
Ikeda Y, Shimada K, Teramoto T, Uchiyama S, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Ishizuka N. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA 2014;312(23):2510- 2520. doi:10.1001/jama.2014.15690.
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Gaziano JM, Brotons C, Coppolecchia R, Crichelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomized doubled-blind, placebo-controlled trial. Lan- cet 2018;392(10152):1036-1046. doi:10. 1016/S0140-6736(18)31924-X.
ASCEND Study Collaborative Group, Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Wa- ters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med 2018;379(16):1529-1539. doi:10.1056/NEJMoa1804988.
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA, Stewart LA, Thomas J, Tricco AC, Welch VA, Whiting P, Moher D. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 1036/bmj.n71.
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan D, McQuay HJ. Assessing the quality of reports of randomized clinical trials: ¿is blinding necessary? Control Clin Trials 1996;17:1–12. https://doi.org/10.1016/0197-2456(95)00134-4.
Barratt A, Wyer PC, Hatala R, McGinn T, Dans AL, Keitz S, Moyer V, For GG; Evidence-Based Medicine Teaching Tips Working Group. Tips for learners of evidence- based medicine: 1. Relative risk reduction, absolute risk reduction, and, number needed to treat. CMAJ 2004;171(4):353-358.doi:10.1503/cmaj.1021197.
Altman DG. Confidence intervals for the number needed to treat. BMJ 1998; 317(7168):1309-1312. doi:10.1136/bmj.317.7168.1309.
Hull RD, Liang J, Bergqvist D, Yusen RD. Benefit-to-harm ratio of thromboprophylaxis for patients undergoing major orthopaedic surgery. A systematic review. Thromb Haemost 2014;111(2):199-212. doi:10.1160/TH13-08-0654.
Evidence Based Medicine: How to practice and teach EBM. Editors: Sharon Straus, Paul Glasziou, W. Scott Richardson, R. Brian Haynes (Spanish) 5th Edition Copyright: © Elsevier 2019, Published: April 7, 2019, eBook ISBN: 9788491135579, pp 360.
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Published
2023-08-25
How to Cite
Vizcaino, G., & Weir Medina, J. (2023). Aspirin in primary cardiovascular prevention: the two faces of the coin and the importance of the Number Needed to Treat: a systematic review and meta- analysis.: Aspirina en prevención cardiovascular primaria. Las dos caras de la moneda y la importancia del número necesario a tratar. Revisión sistemática y metanálisis. Investigación Clínica, 64(3), 405-423. https://doi.org/10.54817/IC.v64n3a11
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