Comparison of ticagrelor with clopidogrel on quality of life in patients with acute coronary syndrome

Hyeyeon Moon, Yoon-Sung Jo, Soo-Jin Kim, Sua Jo, Kyungil Park, Hyeyeon Moon, Yoon-Sung Jo, Soo-Jin Kim, Sua Jo, Kyungil Park

Abstract

Background: Ticagrelor has a Class I recommendation for use following percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS). However, ticagrelor needs to be taken twice a day, as compared to clopidogrel. Its adverse effects, such as dyspnea or bleeding, are known to be more common than with clopidogrel. Dyspnea may tend to be uncomfortable and limit activity. Major bleeding often leads to hospitalization or transfusions, and frequent minor bleeding, which might not result in patients seeking medical care, can make ACS patients feel unhealthy. Thus, these characteristics may affect the health-related quality of life (HQOL).

Methods: In the PLEIO (comParison of ticagreLor and clopidogrEl on mIcrocirculation in patients with acute cOronary syndrome) trial, we randomized 120 participants to receive ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for at least 12 months. We carried out an HQOL assessment with the Short Form 36 Health Survey (SF-36) questionnaire on the day of discharge following PCI, as well as six months later.

Results: At discharge, the HQOL measures were similar in the ticagrelor and clopidogrel groups, both having a physical component summary (PCS) and a mental component summary (MCS) score. A six-month HQOL follow-up assessment showed that there were no differences between the two study groups in either the PCS or the MCS scores. In both groups, the PCS scores significantly increased over six months of treatment (both p < 0.01). However, the MCS score did not differ significantly. A baseline MCS score is an independent predictor of better physical and mental health status at six months.

Conclusions: Ticagrelor, as compared to clopidogrel, did not significantly reduce the HQOL during the six months following PCI in patients with ACS. Clinical Trial Registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT02618733.

Keywords: Acute coronary syndrome; Clopidogrel; Health-related quality of life; Ticagrelor.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow chart showing the enrollment of patients by using the 36-Item Short-Form Health Survey
Fig. 2
Fig. 2
Mean scores over times in PCS and MCS of the SF-36 in ticagrelor and clopidogrel groups. Shown are mean (± SE) measure levels of PCS (Panel A), are mean (± SE) measure levels of MCS (Panel B) from baseline to 6 months in the two study groups. MCS mental component summary, PCS physical component summary

References

    1. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, et al. Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC) Eur Heart J. 2016;37(3):267–315. doi: 10.1093/eurheartj/ehv320.
    1. Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC) Eur Heart J. 2018;39(2):119–177. doi: 10.1093/eurheartj/ehx393.
    1. Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045–1057. doi: 10.1056/NEJMoa0904327.
    1. Shah R, Rashid A, Hwang I, Fan TM, Khouzam RN, Reed GL. Meta-analysis of the relative efficacy and safety of oral P2Y12 inhibitors in patients with acute coronary syndrome. Am J Cardiol. 2017;119(11):1723–1728. doi: 10.1016/j.amjcard.2017.03.011.
    1. Storey RF, Becker RC, Harrington RA, Husted S, James SK, Cools F, et al. Characterization of dyspnoea in PLATO study patients treated with ticagrelor or clopidogrel and its association with clinical outcomes. Eur Heart J. 2011;32(23):2945–2953. doi: 10.1093/eurheartj/ehr231.
    1. Happe LE, Rao SV, Horblyuk R, Franklin M, Lunacsek OE, Menditto L. Consequences of major bleeding in hospitalized patients with non-ST segment elevation acute coronary syndromes receiving injectable anticoagulants. Curr Med Res Opin. 2009;25(2):413–420. doi: 10.1185/03007990802649133.
    1. Shang P, Liu GG, Zheng X, Ho PM, Hu S, Li J, et al. Association between medication adherence and 1-year major cardiovascular adverse events after acute myocardial infarction in China. J Am Heart Assoc. 2019;8(9):e0011793. doi: 10.1161/JAHA.118.011793.
    1. Lee YM, Kim RB, Lee HJ, Kim K, Shin MH, Park HK, et al. Relationships among medication adherence, lifestyle modification, and health-related quality of life in patients with acute myocardial infarction: a cross-sectional study. Health Qual Life Outcomes. 2018;16(1):100. doi: 10.1186/s12955-018-0921-z.
    1. Mommersteeg PMC, Denollet J, Spertus JA, Pedersen SS. Health status as a risk factor in cardiovascular disease: a systematic review of current evidence. Am Heart J. 2009;157(2):208–218. doi: 10.1016/j.ahj.2008.09.020.
    1. Bonaca MP, Bhatt DL, Oude Ophuis T, Steg PG, Storey R, Cohen M, et al. Long-term tolerability of Ticagrelor for the secondary prevention of major adverse cardiovascular events: a secondary analysis of the PEGASUS-TIMI 54 Trial. JAMA Cardiol. 2016;1(4):425–432. doi: 10.1001/jamacardio.2016.1017.
    1. Granger CB, Berger PB. Understanding the adverse effects of Ticagrelor in practice. JAMA Cardiol. 2016;1(4):381–383. doi: 10.1001/jamacardio.2016.1018.
    1. Arora S, Shemisa K, Vaduganathan M, Qamar A, Gupta A, Garg SK, et al. Premature Ticagrelor discontinuation in secondary prevention of atherosclerotic CVD: JACC review topic of the week. J Am Coll Cardiol. 2019;73(19):2454–2464. doi: 10.1016/j.jacc.2019.03.470.
    1. Levin LA, Wallentin L, Bernfort L, Andersson D, Storey RF, Bergström G, et al. Health-related quality of life of Ticagrelor versus Clopidogrel in patients with acute coronary syndromes—results from the PLATO Trial. Value Health. 2013;16(4):574–580. doi: 10.1016/j.jval.2013.01.013.
    1. Doble B, Pufulete M, Harris JM, Johnson T, Lasserson D, Reeves BC, Wordsworth S. Health-related quality of life impact of minor and major bleeding events during dual antiplatelet therapy: a systematic literature review and patient preference elicitation study. Health Qual Life Outcomes. 2018;16(1):191. doi: 10.1186/s12955-018-1019-3.
    1. Park K, Cho YR, Park JS, Park TH, Kim MH, Kim YD. Comparison of the effects of Ticagrelor and Clopidogrel on microvascular dysfunction in patients with acute coronary syndrome using invasive physiologic indices. Circ Cardiovasc Interv. 2019;12(10):e008105. doi: 10.1161/CIRCINTERVENTIONS.119.008105.
    1. Jeong YJ, Park K, Kim YD. Comparison between Ticagrelor and Clopidogrel on myocardial blood flow in patients with acute coronary syndrome, using 13 N-ammonia positron emission tomography. Am Heart J. 2020;222:121–130. doi: 10.1016/j.ahj.2020.01.013.
    1. Peterson RA, Kim Y. On the relationship between coefficient alpha and composite reliability. J Appl Psychol. 2013;98(1):194–198. doi: 10.1037/a0030767.
    1. Park K, Cho YR, Park JS, Park TH, Kim MH, Kim YD. Design and Rationale for comparison between ticagrelor and clopidogrel on microcirculation in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PLEIO) trial. J Cardiovasc Transl Res. 2018;11(1):42–49. doi: 10.1007/s12265-017-9783-8.
    1. Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009;338:a3006. doi: 10.1136/bmj.a3006.
    1. Maruish ME, Maruish M, Kosinski M, Bjorner JB, Gandek B, Turner-Bowker DM, Ware JE. User's manual for the SF-36v2 Health Survey. Lincoln: Quality Metric Inc.; 2011.
    1. Failde I, Ramos I. Validity and reliability of the SF-36 Health Survey Questionnaire in patients with coronary artery disease. J Clin Epidemiol. 2000;53:359–365. doi: 10.1016/s0895-4356(99)00175-4.
    1. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736–2747. doi: 10.1161/CIRCULATIONAHA.110.009449.
    1. Norris CM, Spertus JA, Jensen L, Johnson J, Hegadoren KM, et al. Sex and gender discrepancies in health-related quality of life outcomes among patients with established coronary artery disease. Circ Cardiovasc Qual Outcomes. 2008;1(2):123–130. doi: 10.1161/CIRCOUTCOMES.108.793448.
    1. Unsar S, Sut N, Durna Z. Health-related quality of life in patients with coronary artery disease. J Cardiovasc Nurs. 2007;22(6):501–507. doi: 10.1097/01.JCN.0000297382.91131.8d.
    1. Uchmanowicz I, Loboz-Grudzien K, Jankowska-Polanska B, Sokalski L. Influence of diabetes on health-related quality of life results in patients with acute coronary syndrome treated with coronary angioplasty. Acta Diabetol. 2013;50(2):217–225. doi: 10.1007/s00592-011-0280-2.
    1. Maddox TM, Reid KJ, Rumsfeld JS, Spertus JA. One-year health status outcomes of unstable angina versus myocardial infarction: a prospective, observational cohort study of ACS survivors. BMC Cardiovasc Disord. 2007;7:28. doi: 10.1186/1471-2261-7-28.
    1. Kim MJ, Jeon DS, Gwon HC, Kim SJ, Chang K, Kim HS, et al. Health-related quality-of-life after percutaneous coronary intervention in patients with UA/NSTEMI and STEMI: the Korean Multicenter Registry. J Korean Med Sci. 2013;28(6):848–854. doi: 10.3346/jkms.2013.28.6.848.
    1. Anchah L, Hassali MA, Lim MS, Ibrahim MI, Sim KH, Ong TK. Health related quality of life assessment in acute coronary syndrome patients: the effectiveness of early phase I cardiac rehabilitation. Health Qual Life Outcomes. 2017;15(1):10. doi: 10.1186/s12955-016-0583-7.
    1. Lee BJ, Go JY, Kim AR, Chun SM, Park M, Yang DH, et al. Quality of life and physical ability changes after hospital-based cardiac rehabilitation in patients with myocardial infarction. Ann Rehabil Med. 2017;41(1):121–128. doi: 10.5535/arm.2017.41.1.121.
    1. Rumsfeld JS, MaWhinney S, McCarthy M, Jr, Shroyer AL, VillaNueva CB, O'Brien M, et al. Health-related quality of life as a predictor of mortality following coronary artery bypass graft surgery. Participants of the Department of Veterans Affairs Cooperative Study Group on Processes, Structures, and Outcomes of Care in Cardiac Surgery. JAMA. 1999;281(14):1298–1303. doi: 10.1001/jama.281.14.1298.
    1. Dickens C, Cherrington A, McGowan L. Depression and health-related quality of life in people with coronary heart disease: a systematic review. Eur J Cardiovasc Nurs. 2012;11(3):265–275. doi: 10.1177/1474515111430928.
    1. Bahall M, Legall G, Khan K. Quality of life among patients with cardiac disease: the impact of comorbid depression. Health Qual Life Outcomes. 2020;18(1):189. doi: 10.1186/s12955-020-01433-w.
    1. Tang EW, Wong CK, Herbison P. Global Registry of Acute Coronary Events (GRACE) hospital discharge risk score accurately predicts long-term mortality post acute coronary syndrome. Am Heart J. 2007;153(1):29–35. doi: 10.1016/j.ahj.2006.10.004.
    1. Choi JH, Seo JM, Lee DH, Park K, Kim YD. Clinical utility of new bleeding criteria: a prospective study of evaluation for the Bleeding Academic Research Consortium definition of bleeding in patients undergoing percutaneous coronary intervention. J Cardiol. 2015;65(4):324–329. doi: 10.1016/j.jjcc.2014.06.011.
    1. Park DW, Kwon O, Jang JS, Yun SC, Park H, Kang DY, et al. Clinically significant bleeding with ticagrelor versus clopidogrel in Korean patients with acute coronary syndromes intended for invasive management: a randomized clinical trial. Circulation. 2019;140(23):1865–1877. doi: 10.1161/CIRCULATIONAHA.119.041766.
    1. Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007;297(2):177–186. doi: 10.1001/jama.297.2.177.
    1. Shimbo T, Goto M, Morimoto T, Hira K, Takemura M, Matsui K, et al. Association between patient education and health-related quality of life in patients with Parkinson's disease. Qual Life Res. 2004;13(1):81–89. doi: 10.1023/B:QURE.0000015306.59840.95.
    1. Ghisi GLM, Rouleau F, Ross MK, Dufour-Doiron M, Belliveau SL, Brideau JR, et al. Effectiveness of an education intervention among cardiac rehabilitation patients in Canada: a multi-site study. CJC Open. 2020;2(4):214–221. doi: 10.1016/j.cjco.2020.02.008.
    1. Montiel-Luque A, Núñez-Montenegro AJ, Martín-Aurioles E, Canca-Sánchez JC, Toro-Toro MC, González-Correa JA. Medication-related factors associated with health-related quality of life in patients older than 65 years with polypharmacy. PLoS ONE. 2017;12(2):e0171320. doi: 10.1371/journal.pone.0171320.
    1. Chapman RH, Benner JS, Petrilla AA, Tierce JC, Collins SR, Battleman DS, Schwartz JS. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med. 2005;165(1):1147–1152. doi: 10.1001/archinte.165.10.1147.
    1. Richter A, Anton SF, Koch P, Dennett SL. The impact of reducing dose frequency on health outcomes. Clin Ther. 2003;25(8):2307–2335. doi: 10.1016/s0149-2918(03)80222-9.
    1. Bradley SM, Rumsfeld JS. Depression and cardiovascular disease. Trends Cardiovasc Med. 2015;25(7):614–622. doi: 10.1016/j.tcm.2015.02.002.
    1. Lichtman JH, Froelicher ES, Blumenthal JA, Carney RM, Doering LV, Frasure-Smith N, et al. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014;129(12):1350–1369. doi: 10.1161/CIR.0000000000000019.
    1. Jha MK, Qamar A, Vaduganathan M, Charney DS, Murrough JW. Screening and management of depression in patients with cardiovascular disease: JACC state-of-the-art review. J Am Coll Cardiol. 2019;73(14):1827–1845. doi: 10.1016/j.jacc.2019.01.041.
    1. Rumsfeld JS, Alexander KP, Goff DC, Graham MM, Ho PM, Masoudi FA, et al. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013;127(22):2233–2249. doi: 10.1161/CIR.0b013e3182949a2e.
    1. Malla A, Joober R, Garcia A. "Mental illness is like any other medical illness": a critical examination of the statement and its impact on patient care and society. J Psychiatry Neurosci. 2015;40(3):147–150. doi: 10.1161/CIR.0b013e3182949a2e.
    1. Li R, Yan BP, Dong M, Zhang Q, Yip GW, Chan CP, et al. Quality of life after percutaneous coronary intervention in the elderly with acute coronary syndrome. Int J Cardiol. 2012;155(1):90–96. doi: 10.1016/j.ijcard.2010.09.050.
    1. Azmi S, Goh A, Fong A, Anchah L. Quality of life among patients with acute coronary syndrome in Malaysia. Value Health Reg Issues. 2015;6:80–83. doi: 10.1016/j.vhri.2015.03.015.
    1. Tegn N, Abdelnoor M, Aaberge L, Ranhoff AH, Endresen K, Gjertsen E, et al. Health-related quality of life in older patients with acute coronary syndrome randomised to an invasive or conservative strategy. The After Eighty randomised controlled trial. Age Ageing. 2018;47(1):42–47. doi: 10.1093/ageing/afx121.
    1. Chudek J, Kowalczyk A, Kowalczyk AK, Kwiatkowska J, Raczak G, Kozłowski D. Quality of life (QOL) evaluation after acute coronary syndrome with simultaneous clopidogrel treatment. Arch Med Sci. 2014;10(1):33–38. doi: 10.5114/aoms.2013.38708.
    1. Beck CA, Joseph L, Bélisle P, Pilote L. Predictors of quality of life 6 months and 1 year after acute myocardial infarction. Am Heart J. 2001;142(2):271–279. doi: 10.1067/mhj.2001.116758.
    1. Szygula-Jurkiewicz B, Zembala M, Wilczek K, Wojnicz R, Polonski L. Health related quality of life after percutaneous coronary intervention versus coronary artery bypass graft surgery in patients with acute coronary syndromes without ST-segment elevation. 12-month follow up. Eur J Cardiothorac Surg. 2005;27(5):882–886. doi: 10.1016/j.ejcts.2005.01.037.

Source: PubMed

3
Se inscrever