SpringerLink
Log in

Two-year outcomes of endovascular therapy for femoropopliteal arterial lesions for patients with high bleeding risk

  • Original Article
  • Published:
Cardiovascular Intervention and Therapeutics Aims and scope Submit manuscript

Abstract

The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for femoropopliteal arterial lesions has not been thoroughly investigated. The study population comprised 165 patients undergoing initial EVT for femoropopliteal lesions between June 2018 and June 2020. They were divided into two groups according to the ARC-HBR criteria. The primary end point was a composite of all-cause death, Bleeding Academic Research Consortium type 3 or 5 bleeding, and target lesion revascularization (TLR) within 2 years of EVT. The 165 patients were divided into two groups: 125 (75.8%) patients at HBR (HBR group) and 40 (24.2%) patients at no HBR (non-HBR group). The cumulative incidence of the primary endpoint was significantly higher in the HBR group than in the non-HBR group (40.6% vs. 0%, log-rank p < 0.001). The HBR group had a significantly higher risk of all-cause death, major bleeding, and TLR than the non-HBR group (25.2% vs. 0%, log-rank p = 0.004, 13.9% vs. 0%, log-rank p = 0.047, 16.8% vs. 0%, log-rank p = 0.035). Most patients with peripheral artery disease were classified as HBR patients, and HBR patients were at higher risk of death, major bleeding, and TLR than non-HBR patients.

Graphical abstract

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price includes VAT (United Kingdom)

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

Data availability

The database generated during the current study are available from the corresponding author on reasonable request.

References

  1. Bhardwaj B, Spertus JA, Kennedy KF, Jones WS, Safey D, Tsai TT, et al. Bleeding complications in lower-extremity peripheral vascular interventions: insights from the NCDR PVI registry. JACC Cardiovasc Interv. 2019;12:1140–9.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019;40:2632–53.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Cao D, Mehran R, Dangas G, Baber U, Sartori S, Chandiramani R, et al. Validation of the Academic Research Consortium high bleeding risk defnition in contemporary PCI patients. J Am Coll Cardiol. 2020;75:2711–22.

    Article  PubMed  Google Scholar 

  4. Natsuaki M, Morimoto T, Shiomi H, Yamaji K, Watanabe H, Shizuta S, et al. Application of the Academic Research Consortium high bleeding risk criteria in an all-comers registry of percutaneous coronary intervention. Circ Cardiovasc Interv. 2019;12(11):e008307.

    Article  PubMed  Google Scholar 

  5. Miura K, Shimada T, Ohya M, Murai R, Amano H, Kubo S, et al. Prevalence of the academic research consortium for high bleeding risk criteria and prognostic value of a simplifed defnition. Circ J. 2020;84:1560–7.

    Article  PubMed  Google Scholar 

  6. Nakamura M, Kadota K, Nakao K, Nakagawa Y, Shite J, Yokoi H, et al. High bleeding risk and clinical outcomes in East Asian patients undergoing percutaneous coronary intervention: the PENDULUM Registry. EuroIntervention. 2021;16:1154–62.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Shima Y, Miura K, Shimada T, Ohya M, Murai R, Kubo S, et al. Impact of ischemic risk factors on long-term outcomes in patients with and without high bleeding risk. Int J Cardiol. 2021;326:12–8.

    Article  PubMed  Google Scholar 

  8. Ueki Y, Bär S, Losdat S, Otsuka T, Zanchin C, Zanchin T, et al. Validation of the Academic Research Consortium for high bleeding risk (ARC-HBR) criteria in patients undergoing percutaneous coronary intervention and comparison with contemporary bleeding risk scores. EuroIntervention. 2020;16:371–9.

    Article  PubMed  Google Scholar 

  9. Hashimoto R, Numasawa Y, Yokokura S, Daigo K, Sakata S, Imaeda S, et al. Prevalence of the Academic Research Consortium high bleeding risk criteria in patients undergoing endovascular therapy for peripheral artery disease in lower extremities. Heart Vessels. 2021;36:1350–8.

    Article  PubMed  Google Scholar 

  10. Yoshioka N, Takagi K, Morita Y, Kanzaki Y, Nagai H, Watanabe N, et al. Bleeding events and mid-term mortality in the patients undergoing endovascular interventions for peripheral artery disease of the lower limbs based on the academic research consortium high bleeding risk criteria. Heart Vessels. 2021;36:1336–49.

    Article  PubMed  Google Scholar 

  11. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding defnitions for cardiovascular clinical trials: a consensus report from the bleeding Academic Research Consortium. Circulation. 2011;123:2736–47.

    Article  PubMed  Google Scholar 

  12. Soga Y, Iida O, Takahara M, Hirano K, Suzuki K, Kawasaki D, et al. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014;7:1444–9.

    Article  PubMed  Google Scholar 

  13. Guo X, Xue G, Huang X, **e H, Liang W, Zhang J, et al. Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study. BMC Cardiovasc Disord. 2015;15:44.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Khan MS, Zou F, Khan AR, Moustafa A, Schmid CH, Baig M, et al. Meta-analysis comparing endovascular treatment modalities for femoropopliteal peripheral artery disease. Am J Cardiol. 2020;128:181–8.

    Article  PubMed  Google Scholar 

  15. Takahara M, Iida O, Kohsaka S, Soga Y, Fujihara M, Shinke T, et al. Diabetes mellitus and other cardiovascular risk factors in lower-extremity peripheral artery disease versus coronary artery disease: an analysis of 1,121,359 cases from the nationwide databases. Cardiovasc Diabetol. 2019;18:155.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Numasawa Y, Inohara T, Ishii H, Kuno T, Kodaira M, Kohsaka S, et al. Comparison of outcomes of women versus men with non-ST-elevation acute coronary syndromes undergoing percutaneous coronary intervention (from the Japanese nationwide registry). Am J Cardiol. 2017;119(6):826–31.

    Article  PubMed  Google Scholar 

  17. Chandiramani R, Cao D, Claessen BE, Sorrentino S, Guedeney P, Blum M, et al. Sex-related differences in patients at high bleeding risk undergoing percutaneous coronary intervention: a patient-level pooled analysis from 4 postapproval studies. J Am Heart Assoc. 2020;9:e014611.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Shu J, Santulli G. Update on peripheral artery disease: epidemiology and evidence-based facts. Atherosclerosis. 2018;275:379–81.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Takeji Y, Yamaji K, Tomoi Y, Okazaki J, Tanaka K, Nagae A, et al. Impact of frailty on clinical outcomes in patients with critical limb ischemia. Circ Cardiovasc Interv. 2018;11:e006778.

    Article  PubMed  Google Scholar 

  20. Gebauer K, Engelbertz C, Malyar NM, Meyborg M, Lüders F, Freisinger E, et al. Long-term mortality after invasive angiography and endovascular revascularization in patients with PAD having chronic kidney disease. Angiology. 2016;67:556–64.

    Article  CAS  PubMed  Google Scholar 

  21. Senthong V, Wu Y, Hazen SL, Tang WH. Predicting longterm prognosis in stable peripheral artery disease with baseline functional capacity estimated by the Duke Activity Status Index. Am Heart J. 2017;184:17–25.

    Article  PubMed  Google Scholar 

  22. Soga Y, Iida O, Takahara M, Takahaera M, Hirano K, Suzuki K, et al. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014;7:1444–9.

    Article  PubMed  Google Scholar 

  23. Shiraki T, Iida O, Takahara M, Masuda M, Okamoto S, Ishihara T, et al. The geriatric nutritional risk index is independently associated with prognosis in patients with critical limb ischemia following endovascular therapy. Eur J Vasc Endovasc Surg. 2016;52:218–24.

    Article  CAS  PubMed  Google Scholar 

  24. Garimella PS, Hirsch AT. Peripheral artery disease and chronic kidney disease: clinical synergy to improve outcomes. Adv Chronic Kidney Dis. 2014;21:460–71.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from PARIS. J Am Coll Cardiol. 2016;67:2224–34.

    Article  PubMed  Google Scholar 

  26. Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, et al. Major bleeding in patients with peripheral artery disease: insights from the EUCLID trial. Am Heart J. 2020;220:51–8.

    Article  CAS  PubMed  Google Scholar 

  27. Spiliopoulos S, Tsochatzis A, Festas G, Reppas L, Christidi F, Palialexis K, et al. A new preprocedural score to predict bleeding complications of endovascular interventions for peripheral artery disease. J Endovasc Ther. 2019;26:816–25.

    Article  PubMed  Google Scholar 

  28. Matsi PJ, Manninen HI. Complications of lower-limb percutaneous transluminal angioplasty: a prospective analysis of 410 procedures on 295 consecutive patients. Cardiovasc Intervent Radiol. 1998;21:361–6.

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgements

We are grateful to Miho Kobayashi for her editing assistance.

Author information

Authors and Affiliations

  1. Department of Cardiovascular Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, 710-8602, Japan

    Yuki Shima, Narumi Taninobu, Akihiro Ikuta, Kazunori Mushiake, Hiroyuki Tanaka & Kazushige Kadota

Authors
  1. Yuki Shima
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Narumi Taninobu
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Akihiro Ikuta
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Kazunori Mushiake
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hiroyuki Tanaka
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Kazushige Kadota
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yuki Shima.

Ethics declarations

Conflict of interest

The authors declare that there are no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Shima, Y., Taninobu, N., Ikuta, A. et al. Two-year outcomes of endovascular therapy for femoropopliteal arterial lesions for patients with high bleeding risk. Cardiovasc Interv and Ther 39, 284–292 (2024). https://doi.org/10.1007/s12928-024-00999-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12928-024-00999-2

Keywords

Search

Navigation