Preview

Rational Pharmacotherapy in Cardiology

Advanced search

Characteristics of the Russian population of patients with coronary artery disease or peripheral artery disease in the XATOA registry

https://doi.org/10.20996/1819-6446-2024-3038

EDN: OBSZMI

Abstract

Aim. To analyze demographic, anamnestic and clinical parameters in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD) included in the XATOA study from Russian centers and to compare them with the total population of the international registry.

Material and methods. XATOA study is an international, multicenter, prospective registry, where characteristics of patients receiving dual pathway inhibition therapy with rivaroxaban 2,5 mg twice a day and low-dose acetylsalicylic acid (ASA) daily were analyzed. The secondary endpoint of the study was to assess clinical outcomes and bleeding rates in real world setting.

This analysis was based on the comparison of indicators presented in tables of descriptive statistics from the XATOA study database for subjects from Russia and the general study database respectively. The methodology of this sub-analysis is descriptive only and does not imply any statistical difference assessment.

Results. The Russian population included 795 subjects: 232 (29.2%) subjects with CAD; 293 (36.9%) subjects with PAD and 270 (34.0%) subjects with both. The average follow-up period was 14.4 months. The most common antithrombotic treatment regimen for patients with CAD or PAD prior enrollment in the registry was ASA monotherapy (81.3%); ACE inhibitors/ARBs were prescribed in 61.8%, lipid-l owering therapy in 68.9%. After the enrollment and prescription of rivaroxaban 2.5 mg BID + ASA, the incidence of myocardial infarction, stroke or cardio-v ascular death in subjects in the Russian Federation remained at 1.9%, and the incidence of major adverse limb events (MALE) at 0.8%, which corresponds to the results obtained in the COMPASS randomized controlled trial. Major bleeding was reported in 1 subject (<0.1%). Adherence to the therapy among subjects in the Russian Federation amounted to 89.8%.

Conclusion. Despite the increased incidence of concomitant diseases and insufficient use of routine cardiovascular therapy in subjects with CAD or PAD in the Russian Federation, the ischemic complications rate remains at a relatively low level while using antithrombotic treatment with rivaroxaban 2.5 mg twice a day + ASA 100 mg a day.

About the Authors

V. S. Arakelyan
Bakulev National Medical Research Center for Cardiovascular Surgery
Russian Federation

Valeriy S. Arakelyan

Moscow



A. D. Erlikh
Pirogov Russian National Research Medical University
Russian Federation

Alexey D. Erlikh

Moscow



N. Sh. Amirov
Head of Cardiovascular and Kidneys medical department, Bayer JSC
Russian Federation

Nazim Sh. Amirov

Moscow



E. Dubar
Yudin State Clinical Hospital
Russian Federation

Emel Dubar

Moscow



K. Vogtlaender
Medical Affairs Statistics, Bayer AG
Germany

Kai Vogtlaender

Wuppertal



S. Debus
6Center for Vascular Medicine, UKE Clinic
Germany

Sebastian Debus

Hamburg



References

1. Mensah GA, Roth AG, Fuster V. The Global Burden of Cardiovascular Diseases and Risk Factors 2020 and Beyond. J Am Coll Cardiol. 2019;74(20):2529-32. DOI:10.1016/j.jacc.2019.10.009.

2. Bentzon JF, Otsuka F, Virmani R, Falk E. Mechanisms of plaque formation and rupture. Circ Res. 2014;114(12):1852-66. DOI:10.1161/CIRCRESAHA.114.302721.

3. Drouet L. Atherothrombosis as a systemic disease. Cerebrovasc Dis. 2002;13 Suppl. 1:1-6. DOI:10.1159/000047782.

4. Aboyans V, Ricco JB, Bartelink ML, et al.; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Eur Heart J. 2018;39(9):763-816. DOI:10.1093/eurheartj/ehx095.

5. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 69(11):e71-e126. DOI:10.1016/j.jacc.2016.11.007.

6. Cortés-Beringola A, Fitzsimons D, Pelliccia A, et al. Planning secondary prevention: room for improvement. Eur J Prev Cardiol. 2017;24(3_suppl):22-28. DOI:10.1177/2047487317704954.

7. Narula N, Dannenberg AJ, Olin JW, et al. Pathology of peripheral artery disease in patients with critical limb ischemia. J Am Coll Cardiol. 2018;72(18):2152-63. DOI:10.1016/j.jacc.2018.08.002.

8. Fox KAA, Eikelboom JW, Anand SS, et al. Anti-thrombotic options for secondary prevention in patients with chronic atherosclerotic vascular disease: what does COMPASS add? Eur Heart J. 2019;40(18):1466-71. DOI:10.1093/eurheartj/ehy347.

9. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996;348(9038):1329-39. DOI:10.1016/S0140-6736(96)09457-3.

10. Morrow DA, Braunwald E, Bonaca MP, et al.; TRA 2P–TIMI 50 Steering Committee and Investigators. Vorapaxar in the secondary prevention of atherothrombotic events. N Engl J Med. 2012;366(15):1404-13. DOI:10.1056/NEJMoa1200933.

11. Hiatt WR, Fowkes FG, Heizer G, et al.; EUCLID Trial Steering Committee and Investigators. Ticagrelor versus clopidogrel in symptomatic peripheral artery disease. N Engl J Med. 2017;376(1):32-40. DOI:10.1056/NEJMoa1611688.

12. Eikelboom JW, Connolly SJ, Bosch J, et al.; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377(14):1319-30. DOI:10.1056/NEJMoa1709118.

13. Connolly SJ, Eikelboom JW, Bosch J, et al.; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-b lind, placebo-controlled trial. Lancet. 2018;391(10117):205-18. DOI:10.1016/S0140-6736(17)32458-3.

14. Anand SS, Bosch J, Eikelboom JW, et al.; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018;391(10117):219-29. DOI:10.1016/S0140-6736(17)32409-1.

15. Anand SS, Eikelboom JW, Dyal L, et al.; COMPASS Investigators. Rivaroxaban plus aspirin versus aspirin in relation to vascular risk in the COMPASS trial. J Am Coll Cardiol. 2019;73(25):3271-80. DOI:10.1016/j.jacc.2019.02.079.

16. Eikelboom JW, Bosch JJ, Connolly SJ, et al. Major bleeding in patients with coronary or peripheral artery disease treated with rivaroxaban plus aspirin. J Am Coll Cardiol. 2019;74(12):1519-28. DOI:10.1016/j.jacc.2019.07.065.

17. Knuuti J, Wijns W, Saraste A, et al.; ESC Scientific Document Group. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41(3):407-77. DOI:10.1093/eurheartj/ehz425.

18. Cosentino F, Grant PJ, Aboyans V, et al.; ESC Scientific Document Group. 2019 ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41(2):255-323. DOI:10.1093/eurheartj/ehz486.

19. Seferovic PM, Ponikowski P, Anker SD, et al. Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019;21(10):1169-86. DOI:10.1002/ejhf.1531.

20. Frank U, Nikol S, Belch J, et al. ESVM guideline on peripheral arterial disease. Vasa. 2019;48(102):1-79. DOI:10.1024/0301-1526/a000834.

21. Conte MS, Bradbury AW, Kolh P, et al.; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg. 2019;58(1):S1-S109e33. DOI:10.1016/j.ejvs.2019.05.006.

22. Aboyans V, Bauersachs R, Mazzolai L, et al. Antithrombotic therapies in aortic and peripheral arterial diseases in 2021: a consensus document from the ESC working group on aorta and peripheral vascular diseases, the ESC working group on thrombosis, and the ESC working group on cardiovascular pharmacotherapy. Eur Heart J. 2021;42(39):4013-24. DOI:10.1093/eurheartj/ehab390.

23. Belch JJF, Brodmann M, Baumgartner I, et al. Lipid-lowering and anti-thrombotic therapy in patients with peripheral arterial disease: European Atherosclerosis Society/European Society of Vascular Medicine Joint Statement. Atherosclerosis. 2021;338:55-63. DOI:10.1016/j.atherosclerosis.2021.09.022.

24. Fox KA, Anand SS, Aboyans V, et al. Xarelto plus acetylsalicylic acid: treatment patterns and outcomes in patients with atherosclerosis (XATOA): rationale and design of a prospective registry study to assess rivaroxaban 2.5 mg twice daily plus aspirin for prevention of atherothrombotic events in coronary artery disease, peripheral artery disease, or both. Am Heart J. 2020;222:16673. DOI:10.1016/j.ahj.2020.01.015.

25. Shalnova SA, Oganov RG, Deev AD, et al. comorbidities of ischemic heart disease with other non-communicable diseases in adult population: age and risk factors association. Cardiovascular Therapy and Prevention. 2015;14(4):4451. (In Russ.) DOI:10.15829/1728-8800-2015-4-44-51.

26. Ragino YuI, Kuzminykh NA, Shcherbakova LV, et al. Prevalence of coronary heart disease (by epidemiological criteria) and its association with lipid and non-lipid risk factors in the Novosibirsk population of 25-45 years. Russian Journal of Cardiology. 2019;(6):78-84 (In Russ.) DOI:10.15829/15604071-2019-6-78-84.

27. Kalashnikov VY, Vikulova OK, Zheleznyakova AV, et al. Epidemiology of cardiovascular diseases among patients with diabetes mellitus according to the federal diabetes register of the Russian Federation (2013–2016). Diabetes mellitus. 2019;22(2):105-114 (In Russ.) DOI:10.14341/DM10167.


Review

For citations:


Arakelyan V.S., Erlikh A.D., Amirov N.Sh., Dubar E., Vogtlaender K., Debus S. Characteristics of the Russian population of patients with coronary artery disease or peripheral artery disease in the XATOA registry. Rational Pharmacotherapy in Cardiology. 2024;20(2):241-248. (In Russ.) https://doi.org/10.20996/1819-6446-2024-3038. EDN: OBSZMI

Views: 356


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)