Skip to main content

Advertisement

SpringerLink
Log in

Efficacy of statin treatment after endovascular therapy for isolated below-the-knee disease in patients with critical limb ischemia

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

Abstract

To investigate the efficacy of statin treatment after endovascular therapy (EVT) for isolated below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI). From March 2004 to June 2011, 812 patients (984 limbs, 69.0 % male, 71.6 ± 10.0 years old) with CLI underwent successful EVT for de novo isolated BTK lesions at 11 cardiovascular centers in Japan. Of these patients, 169 patients were treated with statins. Successful EVT was defined as direct-line flow to the pedal arch with <30 % residual stenosis. The multicenter data were analyzed retrospectively for outcomes of overall survival, amputation-free survival (AFS), cardiovascular death, limb salvage, freedom from repeat revascularization, and major adverse limb events [MALE: repeat revascularization for the limb or major amputation (defined as above-the-ankle amputation)]. The mean follow-up period was 19.4 ± 17.6 months. Overall survival, AFS and freedom from repeat revascularization at 4 years were significantly higher in patients treated with statins (64.5 vs. 45.9 %, P = 0.004; 64.1 vs. 43.0 %, P = 0.003; and 56.4 vs. 45.4 %, P = 0.03, respectively). However, rates of cardiovascular death, limb salvage, and MALE at 4 years did not differ significantly between the two groups (86.0 vs. 75.2 %, P = 0.11; 87.2 vs. 87.7 %, P = 0.39; and 84.4 vs. 82.9 %, P = 0.64, respectively). After adjusting all outcomes against differences in prespecified baseline variables, there was no significant difference in overall survival, AFS, cardiovascular death, limb salvage, repeat revascularization, and MALE between the groups. In a subgroup of 513 patients who were ambulatory at baseline, statin treatment significantly improved overall survival [hazard ratio (HR) 0.54, 95 % confidential interval (CI) 0.29–0.97, adjusted P = 0.04] and numerically improved AFS (HR 0.63, 95 % CI 0.35–1.07, adjusted P = 0.086). In this subgroup analysis, there was no significant difference in the rates of repeat revascularization, cardiovascular death, limb salvage, and MALE between patients treated with and without statins. In this retrospective study, the statin treatment after successful EVT establishing one straight line for isolated BTK lesions with CLI do not influence overall survival, AFS, and the rates of cardiovascular death, limb salvage, and MALE. However, in ambulatory patients, the statins may improve overall survival and AFS after successful EVT establishing one straight line for isolated BTK lesions.

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

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. Al-Omran M, Tu JV, Johnston KW, et al. Use of interventional procedures for peripheral arterial occlusive disease in Ontario between 1991 and 1998: a population-based study. J Vasc Surg. 2003;38:289–95.

    Article  PubMed  Google Scholar 

  2. Tomoharu Dohi, Osamu Iida, Shin Okamoto, Kiyonori Nanto, Shinsuke Nanto, Masaaki Uematsu. Mid-term clinical outcome following endovascular therapy in patients with chronic aortic occlusion. Cardiovasc Interv Ther. 2013 Mar 29 [Epub ahead of print].

  3. Adam DJ, Beard JD, Cleveland T, et al. BASIL trial participants: bypass versus angioplasty in severe ischemic of the leg (BASIL): multicenter, randomized controlled trial. Lancet. 2005;366:1925–34.

    Article  PubMed  CAS  Google Scholar 

  4. Giles KA, Pomposelli FB, Spence TL, Hamdan AD, Blattman SB, Panossian H, Schermerhorn ML. Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic Intersociety Consensus class to outcome in 176 limbs. J Vasc Surg. 2008;48:128–36.

    Article  PubMed  Google Scholar 

  5. Bosiers M, Hart JP, Deloose K, Verbist J, Peeters P. Endovascular therapy as the primary approach for limb salvage in patients with critical limb ischemia: experience with 433 infrapopliteal procedures. Vascular. 2006;14:63–9.

    Article  PubMed  Google Scholar 

  6. Conrad MF, Kang J, Cambria RP, Brewster DC, Watkins MT, Kwolek CJ, LaMuraglia GM. Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease. J Vasc Surg. 2009;50:799–805.

    Article  PubMed  Google Scholar 

  7. Nakano Masatsugu, Muramatsu Toshiya, Hirano Keisuke, Tsukahara Reiko, Itou Yoshiaki, Ishimori Hiroshi. Six-month clinical outcomes after below-the-knee angioplasty for critical limb ischemia in patients on hemodialysis. Cardiovasc Interv Ther. 2010;25(2):91–7.

    Article  Google Scholar 

  8. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999–2000. Circulation. 2004;110(6):738–43.

    Article  PubMed  Google Scholar 

  9. MRC/BHF Heart protection study of cholesterol lowering with simvastatin in 20536 high risk individuals: a randomized placebo-controlled trial. Lancet 2002,360:7–22.

    Google Scholar 

  10. Heart protection Study Collaborative Group. Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20536 people with peripheral arterial disease and other high risk conditions. J Vasc Surg. 2007;45:645–54 discussion: 653–4.

    Article  Google Scholar 

  11. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(Suppl 1):S1–75.

    Article  PubMed  Google Scholar 

  12. Fernandez N, McEnaney R, Marone LK, Rhee RY, Leers S, Makaroun M, Chaer RA. Multilevel versus isolated endovascular tibial interventions for critical limb ischemia. J Vasc Surg. 2011;54(3):722–9.

    Article  PubMed  Google Scholar 

  13. Iida O, Soga Y, Hirano K, Kawasaki D, Suzuki K, Miyashita Y, et al. Long-term results of direct and indirect endovascular revascularization based on the angiosome concept in patients with critical limb ischemia presenting with isolated below-the-knee lesions. J Vasc Surg. 2012;55(2):363–70.

    Article  PubMed  Google Scholar 

  14. Kennedy J, Quan H, Buchan AM, Ghali WA, Feasby TE. Statins are associated with better outcomes after carotid endarterectomy in symptomatic patients. Stroke. 2005;36:2073–6.

    Article  Google Scholar 

  15. McNally MM, Agle SC, Parker FM, Bogey WM, Powell CS, Stoner MC. Preoperative statin therapy is associated with improved outcomes and resource utilization in patients undergoing aortic aneurysm repair. J Vasc Surg. 2010;51(6):1390–6.

    Article  PubMed  Google Scholar 

  16. Zhou Q, Liao JK. Pleiotropic effects of statins. Basic research and clinical perspectives. Circ J. 2010;74(5):818–26.

    Article  PubMed  CAS  Google Scholar 

  17. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, et al. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009;373:1175–82.

    Article  PubMed  CAS  Google Scholar 

  18. Takayama T, Hiro T, Yamagishi M, Daida H, Hirayama A, Saito S, et al. Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Circ J. 2009;73:2110–7.

    Article  PubMed  CAS  Google Scholar 

  19. Goodney PP, Likosky DS. Cronenwett JL; Vascular Study Group of Northern New England. Predicting ambulation status one year after lower extremity bypass. J Vasc Surg. 2009;49(6):1431–9.

    Article  PubMed  Google Scholar 

  20. Fernandez Nathan, McEnaney Ryan, Marone Luke K, Rhee Robert Y, Leers Steven, Makaroun Michel, Chaer Rabih A. Predictors of failure and success of tibial interventions for critical limb ischemia. J Vasc Surg. 2010;52(4):834–42.

    Article  PubMed  Google Scholar 

  21. Aielllo Fracesco A, Khan Asad A, Meltzer Andrew J, Gallagher Katherine A, McKinsey James F, Schneider Darren B, et al. Statin therapy is associated with superior clinical outcomes after endovascular treatment of critical limb ischemia. J Vasc Surg. 2012;55:371–80.

    Article  Google Scholar 

  22. Iida O, Soga Y, Hirano K, Kawasaki D, Suzuki K, Miyashita Y, Nanto S, Uematsu M, et al. Midterm outcomes and risk stratification after endovascular therapy for patients with critical limb ischaemia due to isolated below-the-knee lesions. Eur J Vasc Endovasc Surg. 2012;43(3):313–21.

    Article  PubMed  CAS  Google Scholar 

  23. Baigent Colin, Landray Martin J, Reith Christina, et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011;377:2181–92.

    Article  PubMed  CAS  Google Scholar 

  24. Fellström BC, Jardine AG, Schmieder RE, et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2010;362(15):1450.

    Google Scholar 

Download references

Conflict of interest

None of the authors have a real or perceived conflict of interest regarding the work in the manuscript.

Author information

Authors and Affiliations

  1. Department of Cardiology, Kokura Memorial Hospital, 1-1 Asano, Kokurakita-ku, 802-0001, Kitakyushu, Japan

    Yusuke Tomoi, Yoshimitsu Soga & Masakiyo Nobuyoshi

  2. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan

    Osamu Iida

  3. Department of Cardiology, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan

    Keisuke Hirano

  4. Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan

    Kenji Suzuki

  5. Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Daizo Kawasaki

  6. Department of Advanced PAD Therapeutics, Shinshu University, Matsumoto, Japan

    Yasutaka Yamauchi

  7. Department of Cardiology, Kikuna Memorial Hospital, Yokohama, Japan

    Yusuke Miyashita

  8. Department of Cardiovascular Medicine, Graduates School of Medicine, Kyoto, Japan

    Junichi Tazaki

Authors
  1. Yusuke Tomoi
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yoshimitsu Soga
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Osamu Iida
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Keisuke Hirano
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kenji Suzuki
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Daizo Kawasaki
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Yasutaka Yamauchi
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Yusuke Miyashita
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Junichi Tazaki
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Masakiyo Nobuyoshi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yusuke Tomoi.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Tomoi, Y., Soga, Y., Iida, O. et al. Efficacy of statin treatment after endovascular therapy for isolated below-the-knee disease in patients with critical limb ischemia. Cardiovasc Interv and Ther 28, 374–382 (2013). https://doi.org/10.1007/s12928-013-0188-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12928-013-0188-6

Keywords

Search

Navigation