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.
Palabras clave:
aspirina, enfermedad cardiovascular, prevención primaria, riesgo hemorrágico, número necesario a tratar
Resumen
La aspirina ha sido un tratamiento esencial para la prevención primaria de las enfermedades cardiovasculares (ECV). Varios estudios controlados aleatorizados no apoyan el uso rutinario de la aspirina principalmente debido a su asociación con el riesgo de sangrado. Esta revisión sistemática tiene como objetivo evaluar la prescripción de aspirina basada en el Número Necesario para Tratar (NNT) y el Número Necesario para Dañar (NNH). Esta combinación proporciona una buena medida del esfuerzo para evitar un resultado desfavorable, sopesado frente a los posibles riesgos asociados. Se realizó una búsqueda de estudios aleatorios sobre el tratamiento con aspirina en dos períodos separados. En el análisis se incluyeron cuatro estudios de 1988 a 1998 y seis de 2001 a 2018 (157 060 participantes). El criterio principal de valoración fue un resultado compuesto de infarto de miocardio no mortal (NFMI), accidente cerebrovascular isquémico no mortal (NFIS) y mortalidad cardiovascular. La hemorragia mayor fue el punto final de seguridad. Se calculó la reducción del riesgo absoluto (RAR), el NNT y el NNH, junto con el riesgo relativo (RR) y el IC del 95% de cada criterio principal de valoración. Los resultados de todos los estudios incluidos (10) mostraron un beneficio neto con el tratamiento con aspirina para NFMI (NNT= 383) y el resultado compuesto (NNT=445) con una reducción significativa del riesgo relativo del 20% (p=0,003; I2= 0%) y 10% (p<0,001; I2 = 0%), respectivamente. Hubo un incremento relevante del 60% en el riesgo de sangrado (p<0,0001, NNH=208; I2 = 3%). El NNT y el NNH pueden constituir medidas de eficacia y riesgo en la toma de decisiones clínicas compartidas. Sin embargo, es importante establecer consistentemente que el riesgo-beneficio de los pacientes debe ser individualizado, y no una guía clínica para todos.
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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.
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Eidelman RS, Hebert PR, Weisman SM, Hennekens CH. An update on aspirin in the primary prevention of cardiovascular disease. Arch Intern Med 2003;163(17):2006- 10. doi: 10.1001/archinte.163.17.2006.
The Medical Research Council’s General Practice Research Framework. Thrombosis prevention trial: a randomized trial of low-intensity oral anticoagulation with warfarin and low-dose aspirin in the primary prevention of ischemic heart disease in men at increased risk Lancet 1998;351(9098):233-241. https://doi.org/10.1016/S0140-6736(97)11475-1.
Hansson L, Zanchetti A, Carruthers SG, Dahlöf B, Elmfeldt D, Julius S, Ménard J, Rahn KH, Wedel H, Westerling S, for the HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomized trial. Lancet 1998;351:1755-1762. https://doi.org/10.1016/s0140-6736(98)04311-6.
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.
US Preventive Services Task Force. Aspirin for the primary prevention of cardiovascular events: recommendation and rationale. Ann Intern Med 2002;136:157-160. doi: 10.7326/0003-4819-136-2-200201150-00015.
Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Greenland P, Grundy SM, Hong Y, Miller NH, Lauer RM, Ockene IS, Sacco RL, Sallis Jr JF, Smith Jr SC, Stone NJ, Taubert KA. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee. Circulation 2002;106(3):388-391. doi: 1161/01.cir.0000020190.45892.75.
Diez-Ewald M, Arocha F, Vizcaíno G. Effect of low-dose of aspirin on platelet function from patients at risk of myocardial infarction (Spanish). Invest Clín 1984;25:125-137.
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.
Zuern CS, Lindemann S, Gawaz M. Platelet function and response to aspirin: gender-specific features and implications for female thrombotic risk and management. Semin Thromb Hemost 2009;35(3):295- 306. doi:10.1055/s-0029-1222608.
Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, Newby LK, Piña IL, Roger VL, Shaw LJ, Zhao D, Beckie TM, Bushnell C, D’Armiento J, Kris-Etherton PM, Fang J, Ganiats TG, Gomes AS, Gracia CR, Haan CK, Jackson EA, Judelson DR, Kelepouris E, Lavie CJ, Moore A, Nussmeier NA, Ofili E, Oparil S, Ouyang P, Pinn VW, Sherif K, Smith SC Jr, Sopko G, Chandra-Strobos N, Urbina EM, Vaccarino V, Wenger NK. Effectiveness-based guidelines for the prevention of cardiovascular disease in women–2011 update: a guideline from the American Heart Association. Circulation 2011;123:1243–1262. doi: 10.1161/ CIR.0b013e31820faaf8.
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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.
McNeil JJ, Wolfe R, Woods RL, Tonkin AM, Donnan GA, Nelson MR, Reid CM, Lockery JE, Kirpach B, Storey E, Shah RC, Williamson JD, Margolis KL, Ernst ME, Abhayaratna WP, Stocks N, Fitzgerald SM, Orchard SG, Trevaks RE, Beilin LJ, Johnston CI, Ryan J, Radziszews- ka B, Jelinek M, Malik M, Eaton CB, Brauer D, Cloud G, Wood EM, Mahady SE, Satterfield S, Grimm R, Murray AM; ASPREE Investigator Group. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med 2018;379(16):1509-1518. doi: 10.1056/ NEJMoa1805819.
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.
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Publicado
2023-08-25
Cómo citar
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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