Design and rationale for the ASSOS study: Appropriateness of aspirin use in medical outpatients a multicenter and observational study

Oğuzhan Çelik, Cem Çil, Bülent Özlek, Eda Özlek, Volkan Doğan, Özcan Başaran, Erkan Demirci, Lütfü Bekar, Macit Kalçık, Osman Karaarslan, Mücahit Yetim, Tolga Doğan, Vahit Demir, Sedat Kalkan, Buğra Özkan, Şıho Hidayet, Gökay Taylan, Zafer Küçüksu, Yunus Çelik, Süleyman Çağan Efe, Onur Aslan, Murat Biteker, Oğuzhan Çelik, Cem Çil, Bülent Özlek, Eda Özlek, Volkan Doğan, Özcan Başaran, Erkan Demirci, Lütfü Bekar, Macit Kalçık, Osman Karaarslan, Mücahit Yetim, Tolga Doğan, Vahit Demir, Sedat Kalkan, Buğra Özkan, Şıho Hidayet, Gökay Taylan, Zafer Küçüksu, Yunus Çelik, Süleyman Çağan Efe, Onur Aslan, Murat Biteker

Abstract

Objective: The aim of this study was to describe the current status of aspirin use and the demographic characteristics of patients on aspirin for primary and secondary prevention of cardiovascular diseases.

Methods: The Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study (ASSOS) trial was a multicenter, cross-sectional, and observational study conducted in Turkey. The study was planned to include 5000 patients from 14 cities in Turkey. The data were collected at one visit, and the current clinical practice regarding aspirin use was evaluated (ClinicalTrials.gov number NCT03387384).

Results: The study enrolled all consecutive patients who were admitted to the outpatient cardiology clinics from March 2018 until June 2018. Patients should be at least 18 years old, have signed written informed consent, and on aspirin (80-325 mg) therapy within the last 30 days. Cardiologists from the hospital participates in the study. Patients were divided into 2 categories according to presence or absence of atherosclerotic cardiovascular disease, namely secondary prevention group and primary prevention group, respectively. The appropriate use of aspirin in the primary and secondary prevention groups was assessed according to the European Society of Cardiology guidelines and US Preventive Services Task Force. The patients' gastrointestinal bleeding risk factors and colorectal cancer risk were evaluated.

Conclusion: The ASSOS registry will be the most comprehensive and largest study in Turkey evaluating the appropriateness of aspirin use. The results of this study help understand the potential misuse of aspirin in a real-world setting.

Conflict of interest statement

Conflict of interest: None declared.

Figures

Figure 1
Figure 1
Geographic distribution of ASSOS study patients in Turkey by region

References

    1. Goli RR, Contractor MM, Nathan A, Tuteja S, Kobayashi T, Giri J. Antiplatelet Therapy for Secondary Prevention of Vascular Disease Complications. Curr Atheroscler Rep. 2017;19:56.
    1. [No authors listed] Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Lancet. 1988;2:349–60.
    1. Berger JS, Brown DL, Becker RC. Low-dose aspirin in patients with stable cardiovascular disease: a meta-analysis. Am J Med. 2008;121:43–9.
    1. Antithrombotic Trialists'(ATT) Collaboration. Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, 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.
    1. Antithrombotic Trialists'Collaboration. Collaborative metaanalysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324:71–86.
    1. Amsterdam EA, Wenger NK, Brindis RG, Casey DE, Jr, Ganiats TG, Holmes DR, Jr, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64:e139–e228.
    1. Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016;134:e123–55.
    1. de Gaetano G. Collaborative Group of the Primary Prevention Project. Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general practice. Collaborative Group of the Primary Prevention Project. Lancet. 2001;357:89–95.
    1. Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med. 2005;352:1293–304.
    1. Belch J, MacCuish A, Campbell I, Cobbe S, Taylor R, Prescott R, et al. Prevention of Progression of Arterial Disease and Diabetes Study Group;Diabetes Registry Group;Royal College of Physicians Edinburgh. Prevention of Progression of Arterial Disease and Diabetes Study Group;Diabetes Registry Group;Royal College of Physicians Ediburgh. 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. BMJ. 2008;337:a1840.
    1. Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, et al. Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008;300:2134–41.
    1. Fowkes FG, Price JF, Stewart MC, Butcher I, Leng GC, Pell AC, et al. Aspirin for Asymptomatic Atherosclerosis Trialists. Aspirin for prevention of cardiovascular events in a general population screened for a low ankle brachial index: a randomized controlled trial. JAMA. 2010;303:841–8.
    1. Ikeda Y, Shimada K, Teramoto T, Uchiyama S, Yamazaki T, Oikawa S, et al. 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;312:2510–20.
    1. Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, et al. ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention &Rehabilitation (EACPR) Eur Heart J. 2016;37:2315–81.
    1. Vandvik PO, Lincoff AM, Gore JM, Gutterman DD, Sonnenberg FA, Alonso-Coello P, et al. 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. Chest. 2012;141(2 Suppl):e637S–e668S.
    1. Goff DC, Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Sr, Gibbons R, et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 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(25 Pt B):2935–59.
    1. Bibbins-Domingo K. 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;164:836–45.
    1. Authors/Task Force Members. Rydén L, Grant PJ, Anker SD, Berne C, Cosentino F, et al. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD) Eur Heart J. 2013;34:3035–87.
    1. Fox CS, Golden SH, Anderson C, Bray GA, Burke LE, de Boer IH, et al. American Heart Association Diabetes Committee of the Council on Lifestyle and Cardiometabolic Health, Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, Council on Quality of Care and Outcomes Research, and the American Diabetes Association. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence: A Scientific Statement From the American Heart Association and the American Diabetes Association. Circulation. 2015;132:691–718.
    1. WHO Progress in the rational use of medicines. World Health Assembly Resolution, WHA60.16. Geneva: World Health Organisation; 2007. p. 71. .
    1. Biteker M, Başaran Ö, Dogan V, Beton O, Tekinalp M, ÇağrıAykan A, et al. Real-life use of digoxin in patients with non-valvular atrial fibrillation: data from the RAMSES study. J Clin Pharm Ther. 2016;41:711–7.
    1. Başaran Ö, Dogan V, Beton O, Tekinalp M, Aykan AC, Kalaycioğlu E, et al. Collaborators. Suboptimal use of non-vitamin K antagonist oral anticoagulants: Results from the RAMSES study. Medicine (Baltimore) 2016;95:e4672.
    1. Schulman S, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3:692–4.
    1. Shah RR, Pillai A, Omar A, Zhao J, Arora V, Kapoor D, et al. Utility of the HAS-BLED Score in Risk Stratifying Patients on Dual Antiplatelet Therapy Post 12 Months After Drug-Eluting Stent Placement. Catheter Cardiovasc Interv. 2017;89:E99–E103.
    1. Seshasai SR, Wijesuriya S, Sivakumaran R, Nethercott S, Erqou S, Sattar N, et al. Effect of aspirin on vascular and nonvascular outcomes: meta-analysis of randomized controlled trials. Arch Intern Med. 2012;172:209–16.
    1. Guirguis-Blake JM, Evans CV, Senger CA, O'Connor EA, Whitlock EP. Aspirin for the Primary Prevention of Cardiovascular Events: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Ann Intern Med. 2016;164:804–13.
    1. Naderi SH, Bestwick JP, Wald DS. Adherence to drugs that prevent cardiovascular disease: a meta-analysis on 376,162 patients. Am J Med. 2012;125:882–7.e1.
    1. VanWormer JJ, Greenlee RT, McBride PE, Peppard PE, Malecki KC, Che J, et al. Aspirin for primary prevention of CVD: are the right people using it? J Fam Pract. 2012;61:525–32.
    1. Doğan V, Başaran Ö, Biteker M, Özpamuk Karadeniz F, Tekkesin Aİ, Çakıllı Y, et al. and Collaborators. Analysis of geographical variations in the epidemiology and management of non-valvular atrial fibrillation: results from the RAMSES registry. Anatol J Cardiol. 2017;18:273–80.
    1. Tsoi KK, Chan FC, Hirai HW, Sung JJ. Risk of gastrointestinal bleeding and benefit from colorectal cancer reduction from long-term use of low-dose aspirin: A retrospective study of 612 509 patients. J Gastroenterol Hepatol. 2018;33:1728–36.
    1. Freedman AN, Slattery ML, Ballard-Barbash R, Willis G, Cann BJ, Pee D, et al. Colorectal cancer risk prediction tool for white men and women without known susceptibility. J Clin Oncol. 2009;27:686–93.

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