В статье приводится анализ результатов крупного международного рандомизированного клинического исследования PLATO, в котором изучался новый антиагрегант тикагрелор в сравнении с клопидогрелом в дополнение к ацетилсалициловой кислоте у пациентов с острым коронарным синдромом (ОКС). Материал содержит описание дизайна исследования, основных результатов, касающихся эффективности и безопасности тикагрелора. Кроме того, в материале представлены те части современных клинических руководств, в которых описывается место тикагрелора в лечении ОКС и которые были изменены по результатам исследования PLATO.
This article provides an analysis of the results of a large international randomized clinical trial PLATO, in which to learn a new antiplatelet ticagrelor compared with clopidogrel in addition to aspirin in patients with acute coronary syndrome (ACS). Material contains a description of the study design, the main results concerning the efficacy and safety of ticagrelor. In addition, the material presented those parts of modern clinical practice guidelines, which describes the location of ticagrelor in the treatment of ACS and which are modified according to a PLATO study.
1. Libby P. Current concepts of the pathogenesis of the acute coronary syndromes. Circulation 2001; 104: 365–72.
2. Husted S, Emanuelsson H, Heptinstall S et al. Pharmacodynamics, pharmacokinetics, and safety of the oral reversible P2Y12 antagonist AZD6140 with aspirin in patients with atherosclerosis: a double-blind comparison to clopidogrel with aspirin. Eur Heart J 2006; 27: 1038–47.
3. Gubler PA, Bliden KP, Butler K et al. Randomized Double-Blind Assessment of the ONSET and OFFSET of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease. The ONSET/OFFSET Study. Circulation 2009; 120: 2577–85.
4. Wallentin L, Backer RC, Budaj A et al. Ticagrelor versus Clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361: 1045–57.
5. James SK, Roe MT, Cannon CP et al. Ticagrelor versus Clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomized PLATelet inhibition and patient outcomes (PLATO) trial. BMJ 2011; 342: d3527.
6. Lindholm D, Varenhorst C, Cannon CP et al. Ticagrelor vs. clopidogrel in patients with non-ST-elevation acute coronary syndrome with or without revascularization: results from the PLATO trial. Eur Heart J. doi:10.1093/eurheartj/ehu16.
7. Steg PG, James S, Harrington RA et al. Ticagrelor Versus Clopidogrel in Patients With ST-Elevation Acute Coronary Syndromes Intended for Reperfusion With Primary Percutaneous Coronary Intervention A Platelet Inhibition and Patient Outcomes (PLATO) Trial Subgroup Analysis. Circulation 2010; 122: 2131–41.
8. Husted S, James S, Becker RC et al. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet ingibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes 2012; 5 (5): 680–8.
9. Wiviott SD, Braunwald E, McCabe CH et al. Prasugrel versus Clopidogrel in patients with Acute Coronary Syndromes. N Engl J Med 2007; 357: 2001–15.
10. James SK, Storey RF, Khurmi NS et al. Ticagrelor versus Clopiogrel in patients with acute coronary syndromes and history of stroke or transient ischemic attack. Circulation 2012; 125 (23): 2914–21.
11. James S, Budaj A, Aylward P et al. Ticagrelor versus Clopidogrel in acute coronary syndromes in relation to renal function: results from the platelet inhibition and patient outcomes (PLATO) trials. Circulation 2010; 122: 1056–67.
12. Keltai M, Tonelli M, Mann JF et al. Renal function and outcomes in acute coronary syndrome: impact of clopidogrel. Eur J Cardiovasc Prev Rahabil 2007; 14: 312–8.
13. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Eur Heart J. doi: 10.1093/eurheartj/ehr236.
14. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation Eur Heart J. doi:10.1093/eurheartj/ehs215;
15. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes http://content.onlinejacc.org/ on 10/12/2014.
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1. Libby P. Current concepts of the pathogenesis of the acute coronary syndromes. Circulation 2001; 104: 365–72.
2. Husted S, Emanuelsson H, Heptinstall S et al. Pharmacodynamics, pharmacokinetics, and safety of the oral reversible P2Y12 antagonist AZD6140 with aspirin in patients with atherosclerosis: a double-blind comparison to clopidogrel with aspirin. Eur Heart J 2006; 27: 1038–47.
3. Gubler PA, Bliden KP, Butler K et al. Randomized Double-Blind Assessment of the ONSET and OFFSET of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease. The ONSET/OFFSET Study. Circulation 2009; 120: 2577–85.
4. Wallentin L, Backer RC, Budaj A et al. Ticagrelor versus Clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361: 1045–57.
5. James SK, Roe MT, Cannon CP et al. Ticagrelor versus Clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomized PLATelet inhibition and patient outcomes (PLATO) trial. BMJ 2011; 342: d3527.
6. Lindholm D, Varenhorst C, Cannon CP et al. Ticagrelor vs. clopidogrel in patients with non-ST-elevation acute coronary syndrome with or without revascularization: results from the PLATO trial. Eur Heart J. doi:10.1093/eurheartj/ehu16.
7. Steg PG, James S, Harrington RA et al. Ticagrelor Versus Clopidogrel in Patients With ST-Elevation Acute Coronary Syndromes Intended for Reperfusion With Primary Percutaneous Coronary Intervention A Platelet Inhibition and Patient Outcomes (PLATO) Trial Subgroup Analysis. Circulation 2010; 122: 2131–41.
8. Husted S, James S, Becker RC et al. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet ingibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes 2012; 5 (5): 680–8.
9. Wiviott SD, Braunwald E, McCabe CH et al. Prasugrel versus Clopidogrel in patients with Acute Coronary Syndromes. N Engl J Med 2007; 357: 2001–15.
10. James SK, Storey RF, Khurmi NS et al. Ticagrelor versus Clopiogrel in patients with acute coronary syndromes and history of stroke or transient ischemic attack. Circulation 2012; 125 (23): 2914–21.
11. James S, Budaj A, Aylward P et al. Ticagrelor versus Clopidogrel in acute coronary syndromes in relation to renal function: results from the platelet inhibition and patient outcomes (PLATO) trials. Circulation 2010; 122: 1056–67.
12. Keltai M, Tonelli M, Mann JF et al. Renal function and outcomes in acute coronary syndrome: impact of clopidogrel. Eur J Cardiovasc Prev Rahabil 2007; 14: 312–8.
13. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Eur Heart J. doi: 10.1093/eurheartj/ehr236.
14. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation Eur Heart J. doi:10.1093/eurheartj/ehs215;
15. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes http://content.onlinejacc.org/ on 10/12/2014.
Авторы
А.Д.Эрлих
ГКБ №29 им. Н.Э.Баумана ДЗ г. Москвы. 111020, Москва, Россия, Госпитальная пл., д. 2;
ФГБУН НИИ физико-химической медицины ФМБА России. 119435, Россия, Москва, ул. Малая Пироговская, д. 1а alexeyerlikh@gmail.com
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A.D.Erlih
29 Bauman City Clinical Hospital. 111020, Russian Federation, Moscow, Gospital'naya pl., d. 2;
Institute of Physico-Chemical Medicine of Russia. 119435, Russian Federation, Moscow, ul. Malaya Pirogovskaya, d. 1a alexeyerlikh@gmail.com