Efficacy of Aspirin and Low-Dose Rivaroxaban in Chronic Limb-Threatening Ischemia Under Different Comorbid Conditions

Efficacy of Aspirin and Low-Dose Rivaroxaban in Chronic Limb-Threatening Ischemia Under Different Comorbid Conditions

Authors

  • Irakli Popkhadze David Agmashenebeli University of Georgia
  • Teimuraz Mosiava David Agmashenebeli University of Georgia
  • Teona Lazishvili Tbilisi Heart Center
  • Manana Gobejishvili Tbilisi Heart Center
  • Davit Abramishvili Tbilisi Heart Center

DOI:

https://doi.org/10.52340/spectri.2025.12.02.09

Keywords:

Chronic limb-threatening ischemia, diabetes mellitus, atherosclerosis, adual pathway inhibition, peripheral arterial disease, infra-popliteal intervention

Abstract

Background: Chronic limb-threatening ischemia (CLTI) in patients with diabetic angiopathy and peripheral atherosclerotic disease is associated with severe thrombotic burden, endothelial dysfunction, impaired distal perfusion, and high risk of restenosis after infra-popliteal revascularization. The coexistence of diabetes mellitus and atherosclerosis further increases vascular complications and negatively affects long-term limb outcomes.

Aim: The aim of the study was to evaluate the effectiveness of aspirin combined with low-dose rivaroxaban in comparison with other antithrombotic regimens in patients with chronic limb-threatening ischemia under different comorbid conditions.

Materials and Methods: A total of 120 patients with infra-popliteal peripheral arterial disease and chronic limb-threatening ischemia were included in the study.

Patients were divided into four treatment groups (30 patients each) according to postprocedural antithrombotic regimen:

  • Group I: aspirin + clopidogrel
  • Group II: aspirin + rivaroxaban 20 mg once daily
  • Group III: aspirin + rivaroxaban 2.5 mg twice daily
  • Group IV: aspirin + clopidogrel + rivaroxaban 2.5 mg twice daily

Additional subgroup analysis was performed according to comorbid background:

  • isolated diabetes mellitus
  • combined diabetes mellitus and atherosclerosis
  • isolated atherosclerosis

Outcomes included thrombotic events, reocclusion, repeated intervention, ABI, primary patency, and restenosis.

Results

In patients with isolated diabetes mellitus or isolated atherosclerosis, differences between treatment groups were relatively modest.

The most pronounced differences were observed in patients with combined diabetes mellitus and atherosclerosis.

In this subgroup, Group III demonstrated the best results:

  • ABI: 0.80 ± 0.13
  • Primary patency: 86.7%
  • Restenosis: 10.0%
  • Thrombotic events: 6.7%

In contrast, Group IV showed the highest thrombotic burden (50.0%), while Group I demonstrated the lowest ABI and primary patency.

Conclusion

The combination of aspirin and low-dose rivaroxaban demonstrated the most favorable vascular outcomes, particularly in patients with coexistence of diabetes mellitus and atherosclerosis, where thrombotic burden is highest.

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Author Biographies

Irakli Popkhadze, David Agmashenebeli University of Georgia

PhD student

Teimuraz Mosiava, David Agmashenebeli University of Georgia

Professor

Teona Lazishvili, Tbilisi Heart Center

MD

Manana Gobejishvili, Tbilisi Heart Center

MD

Davit Abramishvili, Tbilisi Heart Center

MD

References

1. Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN. Rivaroxaban in peripheral artery disease after revascularization. N Engl J Med. 2020;382(21):1994–2004.

2. Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2018;379(3):213–221.

3. Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019;69(6S):3S–125S.

4. Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S. ESC Guidelines on peripheral arterial diseases. Eur Heart J. 2018;39(9):763–816.

5. Hess CN, Norgren L, Ansel GM, Capell WH, Fletcher JP, Fowkes FG, Gottsäter A, Hiatt WR, Jaff MR, Nordanstig J. A structured review of antithrombotic therapy in peripheral artery disease. Circulation. 2017;135(25):2534–2555.

6. Beckman JA, Creager MA. Vascular complications of diabetes. Circ Res. 2016;118(11):1771–1785.

7. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM. 2016 AHA/ACC guideline on lower extremity peripheral artery disease. Circulation. 2017;135(12):e726–e779.

8. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. TASC II consensus document. J Vasc Surg. 2007;45(Suppl S):S5–S67.

9. Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA, Aronow HD, Yeh RW. Long-term antithrombotic therapy after peripheral artery intervention. J Am Coll Cardiol. 2019;73(25):3271–3280.

10. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and limb ischemia. N Engl J Med. 2017;376(24):2367–2375.

11. Hiatt WR, Fowkes FG, Heizer G, Berger JS, Baumgartner I, Held P, Katona BG, Mahaffey KW, Norgren L. Ticagrelor versus clopidogrel in symptomatic peripheral artery disease. N Engl J Med. 2017;376(1):32–40.

12. Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, McDermott MM, Misra S, Ujueta F. Lower extremity peripheral artery disease: contemporary epidemiology and management. Circulation Research. 2021;128(12):1818–1832.

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Published

2026-07-04

How to Cite

Popkhadze, I., Mosiava, T., Lazishvili, T., Gobejishvili, M., & Abramishvili, D. (2026). Efficacy of Aspirin and Low-Dose Rivaroxaban in Chronic Limb-Threatening Ischemia Under Different Comorbid Conditions. Scientific Journal „Spectri“, 12(2). https://doi.org/10.52340/spectri.2025.12.02.09

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