Latent opportunities for the prevention of ischemic stroke in patients with atherosclerosis-related diseases: additional analysis of randomized trials on rivaroxaban
https://doi.org/10.15829/1560-4071-2020-2-3747
Abstract
Practical introduction of drugs requires determining the relationship between the benefits of its use and adverse effects, as well as identifying clinically significant additional benefits of new treatment approaches by analyzing additional parameters or reanalyzing data of randomized controlled trials. Despite the lack of evidence of such analyzes, they often affect the prospects of using drugs in a particular clinical situation. The article discusses new data on the prospects for the use of low-dose rivaroxaban (2,5 mg 2 times a day), which were obtained not only in initial analyzes, but also secondary analyzes of data obtained in randomized trials involving patients with atherosclerosis-related cardiovascular diseases and sinus rhythm.
About the Author
S. R. GilyarevskiyRussian Federation
Moscow
References
1. Merlini PA, Bauer KA, Oltrona L, et al. Persistent activation of coagulation mechanism in unstable angina and myocardial infarction. Circulation. 1994;90:61-8.
2. Rothberg MB, Celestin C, Fiore LD, et al. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: meta-analysis with estimates of risk and benefit. Ann Intern Med. 2005;143:241-50.
3. Wallentin L, Wilcox RG, Weaver WD, et al. Oral ximelagatran for secondary prophylaxis after myocardial infarction: the ESTEEM randomised controlled trial. Lancet. 2003;362:789-97.
4. Keisu M, Andersson TB. Drug-induced liver injury in humans: the case of ximelagatran. Handb Exp Pharmacol. 2010;196:407-18. doi:10.1007/978-3-642-00663-0_13.
5. Oldgren J, Budaj A, Granger CB, et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J. 2011;32:2781-9. doi:10.1093/eurheartj/ehr113.
6. Alexander JH, Lopes RD, James S, et al. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011;365:699-708. doi:10.1056/NEJMoa1105819.
7. Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in Patients with a Recent Acute Coronary Syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi:10.1056/NEJMoa1112277. Epub 2011 Nov 13.
8. Chen B, Cheng Q, Yang K, Lyden PD. Thrombin mediates severe neurovascular injury during ischemia. Stroke. 2010 Oct;41(10):2348-52. doi:10.1161/STROKEAHA.110.584920. Epub 2010 Aug 12.
9. Lee da Y, Park KW, Jin BK. Thrombin induces neurodegeneration and microglial activation in the cortex in vivo and in vitro: proteolytic and non-proteolytic actions. Biochem Biophys Res Commun. 2006;346:727-38.
10. Nishino A, Suzuki M, Ohtani H, et al. Thrombin may contribute to the pathophysiology of central nervous system injury. J Neurotrauma. 1993;10:167-79.
11. Feigin VL, Forouzanfar MH, Krishnamurthi R, et al. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014;383:245-54.
12. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics — 2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2e220. doi:10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15.
13. Bhatt DL, Eagle KA, Ohman EM, et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi:10.1001/jama.2010.1322. Epub 2010 Aug 30.
14. Ducrocq G, Amarenco P, Labreuche J, et al. A history of stroke/transient ischemic attack indicates high risks of cardiovascular event and hemorrhagic stroke in patients with coronary artery disease. Circulation. 2013 Feb 12;127(6):730-8. doi:10.1161/CIRCULATIONAHA.112.141572. Epub 2012 Dec 31.
15. Antithrombotic Trialists’ (ATT) Collaboration, Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi:10.1016/S0140-6736(09)60503-1.
16. Daaboul Y, Korjian S, Plotnikov AN, et al. Rivaroxaban and Post-Stroke Neurological Outcomes in Patients With Acute Coronary Syndrome. J Am Coll Cardiol. 2018;71:1048-9. doi:10.1016/j.jacc.2017.12.045.
17. Anand SS, Yusuf S. Oral anticoagulants in patients with coronary artery disease. J Am Coll Cardiol. 2003;41:Suppl S:62S-69S.
18. Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. NEJM. 2017; 377:1319-30. doi:10.1056/NEJMoa1709118.
19. Sharma M, Hart RG, Connolly SJ, et al. Stroke Outcomes in the COMPASS Trial. Circulation. 2019;139:1134-45. doi:10.1161/CIRCULATIONAHA.118.035864.
20. Zannad F, Anker SD, Byra WM, et al. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J 2018 Oct 4;379(14):1332-1342. doi:10.1056/NEJMoa1808848. Epub 2018 Aug 27.
21. Greenberg B, Neaton JD, Anker SD, et al. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Apr 24. doi:10.1001/jamacardio.2019.1049. [Epub ahead of print].
22. Homma S, Thompson JL, Pullicino PM, et al. Warfarin and aspirin in patients with heart failure and sinus rhythm. N Engl J Med. 2012;366:1859-69. doi:10.1056/NEJMoa1202299.
23. Santulli G. Stroke prevention: Learning from the master (and COMMANDER). Sci Transl Med 2018;10(459). pii: eaav0340. doi:10.1126/scitranslmed.aav0340.
24. Hart RG, Diener HC, Coutts SB, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi:10.1016/S14744422(13)70310-7.
25. Spronk HM, de Jong AM, Crijns HJ, et al. Pleiotropic effects of factor Xa and thrombin: what to expect from novel anticoagulants. Cardiovasc Res. 2014 Mar 1;101(3):344-51. doi:10.1093/cvr/cvt343. Epub 2014 Jan 2.
26. Eikelboom JW, Quinlan DJ, Mehta SR, et al. Unfractionated and low-molecular-weight heparin as adjuncts to thrombolysis in aspirin-treated patients with ST-elevation acute myocardial infarction: a meta-analysis of the randomized trials. Circulation. 2005;112:3855-67.
27. Ren M, Li R, Chen N, et al. Platelet-derived factor v is a critical mediator of arterial thrombosis. J Am Heart Assoc. 2017;6:e006345. doi:10.1161/JAHA.117.006345.
28. Gurbel PA, Fox KAA, Tantry US, et al. Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease. Circulation. 2019;139:2170-85. doi:10.1161/CIRCULATIONAHA.118.033580.
29. Monković DD, Tracy PB. Functional characterization of human platelet-released factor V and its activation by factor Xa and thrombin. J Biol Chem. 1990;265:17132-40.
30. Esmon CT. What did we learn from new oral anticoagulant treatment? Thromb Res. 2012;130(suppl 1):S41-S43. doi:10.1016/j. thromres.2012.08.271.
31. Leon C, Alex M, Klocke A, et al. Platelet ADP receptors contribute to the initiation of intravascular coagulation. Blood. 2004;103:594-600. doi:10.1182/blood-2003-05-1385.
32. Gurbel PA, Bliden KP, Antonino MJ, et al. Time dependence of clopidogrel loading effect: platelet activation versus platelet aggregation. Thromb Res. 2012;129:1-2. doi:10.1016/j.thromres.2011.07.048.
33. Gurbel PA, Bliden KP, Guyer K, et al. Delayed thrombin-induced platelet-fibrin clot generation by clopidogrel: a new dose-related effect demonstrated by thrombelastography in patients undergoing coronary artery stenting. Thromb Res. 2007;119:563-70. doi:10.1016/j.thromres.2006.05.006.
34. Judge HM, Buckland RJ, Sugidachi A, et al. The active metabolite of prasugrel effectively blocks the platelet P2Y12 receptor and inhibits procoagulant and pro-inflammatory platelet responses. Platelets. 2008;19:125-33. doi:10.1080/09537100701694144.
35. Behan MW, Fox SC, Heptinstall S, Storey RF. Inhibitory effects of P2Y12 receptor antagonists on TRAP-induced platelet aggregation, procoagulant activity, microparticle formation and intracellular calcium responses in patients with acute coronary syndromes. Platelets. 2005;16:73-80. doi:10.1080/09537100400005634.
Review
For citations:
Gilyarevskiy S.R. Latent opportunities for the prevention of ischemic stroke in patients with atherosclerosis-related diseases: additional analysis of randomized trials on rivaroxaban. Russian Journal of Cardiology. 2020;25(2):3747. (In Russ.) https://doi.org/10.15829/1560-4071-2020-2-3747