Skip to main content
Log in

PTA Versus Carbofilm-Coated Stents in Infrapopliteal Arteries: Pilot Study

  • CLINICAL INVESTIGATION
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose:

To determine the primary success and short-term patency of stent application as a primary treatment modality for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia in a randomized prospective study.

Methods:

Endovascular therapy was performed on 95 lesions in 51 patients (mean age 72.0 years, range 47–80 years) who presented clinically with Fontaine stages III and IV. One patient underwent treatment in both limbs. After angiographic lesion identification, patients were randomized for treatment by PTA (53 lesions in 27 patients) or stent application (42 lesions in 24 patients). Follow-up by clinical investigation and conventional angiography or spiral CT angiography was performed in 37 patients (57 lesions) 6 to 12 months after the procedure, or when clinically indicated. Evaluation was performed by two observers, double-blinded, with thresholds for lesion restenosis of 50% and 70%. Statistical evaluation was performed on a lesion basis by Kaplan–Meier estimated probability rates, and log-rank and Wilcoxon tests. The primary endpoint was the angiographic patency rate of treated lesions.

Results:

The inter-reader agreement was high (κ = 0.82). For the stent group the cumulative primary patency at 6 months was 83.7% at the 70% restenosis threshold, and 79.7% at the 50% restenosis threshold. For PTA, the primary patency at 6 months was 61.1% at the 70% restenosis threshold and 45.6% at the 50% restenosis threshold. Both results were statistically significant (p < 0.05).

Conclusion:

Infrapopliteal stent application is an effective treatment modality for high-grade lesions in chronic critical limb ischemia. Compared with PTA, higher patency rates can be expected after 6 months.

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

Access this article

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

Instant access to the full article PDF.

Institutional subscriptions

Figure 1
Figure 2
Figure 3
Figure 4

Similar content being viewed by others

References

  1. Kalman PG, Johnston KW, Sniderman KW (1996) Indications and results of balloon angioplasty for arterial occlusive lesions. World J Surg 20:630–634

    Article  CAS  PubMed  Google Scholar 

  2. Hunink MG, Wong JB, Donaldson MC, et al (1995) Revascularization for femoropopliteal disease: A decision and cost-effectiveness analysis. JAMA 274:165-171

    Article  CAS  PubMed  Google Scholar 

  3. Matsi PJ, Manninen HI, Vanninen RL, et al (1994) Femoropopliteal angioplasty in patients with claudication: Primary and secondary patency in 140 limbs with 1–3-year follow up. Radiology 191:727-733

    CAS  PubMed  Google Scholar 

  4. Matsi PJ, Manninen HI, Soder HK, et al (1995) Percutaneous transluminal angioplasty in femoral artery occlusions: Primary and long-term results in 107 claudicant patients using femoral and popliteal catheterisation techniques. Clin Radiol 50:237-244

    CAS  PubMed  Google Scholar 

  5. Jämsen TS, Manninen HI, Jaakkola PA, et al (2002) Long-term outcome of patients with claudication after balloon angioplasty of the femoropopliteal arteries. Radiology 225:345-352

    PubMed  Google Scholar 

  6. Wolfle KD, Bruijnen H, Reeps C, et al (2000) Tibioperoneal arterial lesions and critical foot ischemia: Successful management by the use of short vein grafts and percutaneous transluminal angioplasty. Vasa 29:207–214

    CAS  PubMed  Google Scholar 

  7. Soder HK, Manninen HI, Jaakkola P, et al (2000) Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: Angiographic and clinical results. J Vasc Interv Radiol 11:1021-1031

    CAS  PubMed  Google Scholar 

  8. Boyer L, Therre T, Garcier JM, et al (2000) Infrapopliteal percutaneous transluminal angioplasty for limb salvage. Acta Radiol 41:73-77

    Article  CAS  PubMed  Google Scholar 

  9. Faglia E, Matero M, Caminiti M, et al (2002) Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: Clinical results of a multicentric study of 221 consecutive diabetic subjects. J Intern Med 252:225-232

    Article  CAS  PubMed  Google Scholar 

  10. Bakal CW, Cynamon J, Sprayragen S (1996) Infrapopliteal percutaneous transluminal angioplasty: What we know. Radiology 200:36-43

    CAS  PubMed  Google Scholar 

  11. Wagner HJ, Rager G (1998) Infrapopliteal angioplasty: A forgotten region? ROFO 168:415-420

    CAS  PubMed  Google Scholar 

  12. Henry M, Klonaris C, Amor M, et al (2000) State of the art: Which stent for which lesion in peripheral interventions? Tex Heart Inst J 27:119-126

    CAS  PubMed  Google Scholar 

  13. Rosenblum JD, Leef JA, Kostelic JK, et al (1995) Angioplasty and intravascular stents in peripheral vascular disease. Surg Clin North Am 75:621-632

    CAS  PubMed  Google Scholar 

  14. Antoniucci D, Bartorelli A, Valenti R, et al (2000) Clinical and angiographic outcome after coronary arterial stenting with the Carbostent. Am J Cardiol 85:821-825

    CAS  PubMed  Google Scholar 

  15. Rutherford RB, Baker JD, Ernst C, et al (1997) Recommended standards for reports dealing with lower extremity ischemia: Revised version. J Vasc Surg 26:517-538

    Article  CAS  PubMed  Google Scholar 

  16. Kanitsar A, Fleischmann D, Wegenkittl R, et al. (2002) CPR-curved planar reformation. In: IEEE Visualization. IEEE Computer Society, Boston, MA, pp 37–44

  17. Koechl A, Kanitsar A, Lomoschitz E, et al. (2003) Comprehensive assessment of peripheral arteries using multi-path curved planar reformation of CTA datasets. In: European Congress of Radiology, Vienna, p 268

  18. Fleischmann D (2003) Use of high-concentration contrast media in multiple-detector-row CT: Principles and rationale. Eur Radiol 13 [Suppl 5]:M14-20

    PubMed  Google Scholar 

  19. Fleischmann D, Rubin GD, Bankier AA, et al (2000) Improved uniformity of aortic enhancement with customized contrast medium injection protocols at CT angiography. Radiology 214:363-371

    CAS  PubMed  Google Scholar 

  20. TASC (2000) TASC document. J Vasc Surg 31

  21. Brown KT, Moore ED, Getrajdman GI, et al (1993) Infrapopliteal angioplasty: Long term follow-up. J Vasc Interv Radiol 4:139-144

    CAS  PubMed  Google Scholar 

  22. Dorros G, Jaff M, Dorros AM, et al (2001) Tibioperoneal (outflow lesion) angioplasty can be used as primary treatment in 235 patients with critical limb ischemia. Five years follow-up. Circulation 104:2057-2062

    CAS  PubMed  Google Scholar 

  23. Willoteuax S, Negawi Z, Lions C, et al (2004) Observations from multidetector CT imaging of different types of renal artery stents. J Endovasc Ther 11:560-569

    Google Scholar 

  24. Hong C, Chrysant GS, Woodard PK, et al (2004) Coronary artery stent patency assessed with in-stent contrast enhancement measured at multi-detector row CT angiography: Initial experience. Radiology 233:286-291

    PubMed  Google Scholar 

  25. Maintz D, Seifarth H, Flohr T, et al (2003) Improved coronary artery stent visualization and in-stent stenosis detection using 16-slice computed-tomography and dedicated image reconstruction technique. Invest Radiol 38:790-795

    PubMed  Google Scholar 

  26. Krüger S, Mahnken AH, Sinha AM, et al (2003) Multisclice spiral computed tomography for the detection of coronary stent restenosis and patency. Int J Cardiol 89:167-172

    PubMed  Google Scholar 

  27. Maintz D, Juergens KU, Wichter T, et al (2003) Imaging of coronary artery stents using multislice computed tomography: In vitro evaluation. Eur Radiol 13:830-835

    PubMed  Google Scholar 

  28. Unterberg C, Sandrock D, Nebendahl K, et al (1995) Reduced acute thrombus formation results in decreased neointimal proliferation after coronary angioplasty. J Am Coll Cardiol 26:1747-1754

    Article  CAS  PubMed  Google Scholar 

  29. Schwartz RS, Holder DJ, Holmes DR, et al (1996) Neointimal thickening after severe coronary artery injury is limited by a short-term administration of a factor Xa inhibitor: Results in a porcine model. Circulation 93:1542-1548

    CAS  PubMed  Google Scholar 

  30. Bapapulle MN, Eisenberg MJ (2002) Coated stents for prevention of restenosis: I. Circulation 106:2734-2740

    Google Scholar 

  31. Antoniucci D, Valenti R, Migliorini A, et al (2001) Clinical and angiographic outcomes following elective implantation of the Carbostent in patients at high risk of restenosis and target vessel failure. Catheter Cardiovasc Interv 54:420-426

    CAS  PubMed  Google Scholar 

  32. Jeffcoate WJ, van Houtum WH (2004) Amputation as a marker of the quality of foot care in diabetes. Diabetologia 47:2051-2058

    CAS  PubMed  Google Scholar 

  33. Holstein P, Ellitsgaard N, Olsen BB (2000) Decreasing incidence of major amputations in people with diabetes. Diabetologia 43:844-847

    Article  CAS  PubMed  Google Scholar 

  34. Bertrand ME, Rupprecht HJ, Urban P, et al (2000) Double-blind study of the safety of clopidrogel with and without loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting. Circulation 102:624-629

    CAS  PubMed  Google Scholar 

  35. Popma JJ, Berger P, Ohman EM, et al (2004) Antithrombotic therapy during percutaneous coronary intervention. Chest 126:576S-599S

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

This study was supported by the Ludwig Boltzmann Institute for Radiologic Tumor Diagnosis and the Ludwig Boltzmann Institute of Interdisciplinary Vascular Research.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to T. Rand.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Rand, T., Basile, A., Cejna, M. et al. PTA Versus Carbofilm-Coated Stents in Infrapopliteal Arteries: Pilot Study. Cardiovasc Intervent Radiol 29, 29–38 (2006). https://doi.org/10.1007/s00270-005-0276-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00270-005-0276-9

Keywords

Navigation