Invited commentary

Abstract

The increasingly aggressive endovascular management of tibial artery occlusive disease is understandable given the fact that endovascular surgeons have routinely acquired increased technical skill and gained access to enabling endovascular hardware. However, the many options available to treat atheromatous lesions, including balloon angioplasty, cryoplasty, excisional atherectomy, rotational atherectomy, self-expanding stent placement, covered stent placement, balloon expandable stent placement, and drug-eluting stent placement, have driven the treatment of lesions faster than data has provided guidance. Unlike trials of the use of drug-eluting stents in the superficial femoral artery in which no benefit was noted,1Duda S.H. Bosiers M. Lammer J. Scheinert D. Zeller T. Tielbeek A. et al.Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial.J Vasc Interv Radiol. 2005; 16: 331-338Abstract Full Text Full Text PDF PubMed Scopus (395) Google Scholar, 2Duda S.H. Bosiers M. Lammer J. Scheinert D. Zeller T. Oliva V. et al.Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial.J Endovasc Ther. 2006; 13: 701-710Crossref PubMed Scopus (445) Google Scholar the authors of the Drug Eluting Stents In the Critically Ischemic Lower Leg (DESTINY) trial provide us with level I evidence to support the use of drug-eluting stents over bare-metal stents in the management of tibial arterial lesions. Interestingly, a similar report has been published in an electronic format since the editorial process began on this article.3Rastan A. Tepe G. Krankenberg H. Zahorsky R. Beschorner U. Noory E. et al.Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial.Eur Heart J. 2011; 32: 2274-2281Crossref PubMed Scopus (164) Google Scholar Results are surprisingly similar, with primary patency rates of 80.6% for sirolimus-eluting stents deployed in tibial arteries and 55.6% for lesions treated with bare-metal stents (P =.004) vs the 85% and 54% noted in this study. There is a distinct historical parallel between this increasingly aggressive endovascular treatment of tibial disease and the surgical treatment of tibial disease in the mid-1980s, when bypass grafts were performed both with autogenous vein and with prosthetic conduits. Data from carefully performed clinical trials demonstrated the superiority of autogenous conduit use and thus defined a standard of care.4Bergan J.J. Veith F.J. Bernhard V.M. Yao J.S. Flinn W.R. Gupta S.K. et al.Randomization of autogenous vein and polytetrafluorethylene grafts in femoral-distal reconstruction.Surgery. 1982; 92: 921-930PubMed Google Scholar, 5Veith F.J. Gupta S.K. Ascer E. White-Flores S. Samson R.H. Scher L.A. et al.Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions.J Vasc Surg. 1986; 3: 104-114PubMed Scopus (944) Google Scholar Similarly, a new standard has been set with respect to the use of drug-eluting stents in the tibial arteries. Many basic questions remain unanswered, however. The most fundamental is how the use of stents fits into the overall scheme of the endovascular management of tibial vessel occlusive disease. The effectiveness of a strategy involving the use of drug-eluting stents vs angioplasty alone, atherectomy, or any other adjunctive measure remains untested. Furthermore, although the endovascular surgeon can now treat tibial artery lesions with drug-eluting stents and can point to specific data to support this approach, this study has important limitations that limit its generalizability. The lesions treated in this study were <40 mm in length, which, of course, represents a relatively small subset of the patients with treatable tibial disease. An intervention to improve the outcomes of recanalization of long tibial segments remains elusive. We are in the infancy of our understanding of the best means of treating tibial vessel occlusive disease, but we now have some level I data to guide our decision making. However, of all of the treatment paradigms for the management of tibial disease, this may be the most expensive. Further research will help define the cost-effectiveness of this approach. The next step in the evolution of our understanding of the most appropriate treatment of tibial disease will compare the use of drug-eluting stents vs other available technologies, such as balloon angioplasty and atherectomy, for lesions suitable for endovascular treatment. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive diseaseJournal of Vascular SurgeryVol. 55Issue 2PreviewCritical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. 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