Why Drug-Eluting Stents May Not Work for Most Patients with Leg Ischemia Caused by Below-Knee Arterial Occlusive Disease
- Volume 5 - Issue 5 - Sept/Oct 2008
- Posted on: 9/17/08
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Marc Bosiers, MD, Koen Deloose, MD, Jurgen Verbist, MD, Patrick Peeters, MD
The coronary DES trials have taught us another important lesson: inadequate lesion coverage may contribute to the development of edge stenosis (or restenosis), negatively impacting the SES efficacy. A quantitative intravascular ultrasound (IVUS) analysis from the Sirolimus-Eluting Stent in Coronary Lesions (SIRIUS) trial demonstrated a larger percentage of uncovered plaque area at the reference segment in SES population presenting with edge stenosis 8 months after index intervention.8
Consequently, in the typical CLI patient presenting with long, diffuse infrapopliteal lesion, an optimal DES effect can only be achieved if the full length of the index lesion is covered with DES. Adhering to such a strategy would require use of multiple DES devices in the majority of patients. This would have, of course, an obvious and severe impact on the cost of the procedure (Figure 4).
In the publication of Commeau et al, which describes his experience with direct stenting with SES in the infrapopliteal bed, there were no restrictions in terms of the number of SES implanted or in the maximum-allowed lesion length. They reported on the use of 106 SES stents in only 30 patients. This means an average of 3.5 SES per patient, with even one patient that received 13 stents.5 This undoubtedly creates an inevitable price issue: can the gained patency ever justify the increased treatment costs?
Another concern with using DES in the infrapopliteal arteries is the delayed endothelialization around the stent struts as seen in coronaries, which makes the stent more susceptible to thrombosis. Despite the fact that DES thrombosis in the peripheral circulation has not had the lethal consequences seen in the coronaries arteries, use of dual antiplatelet therapy after DES is also warranted for peripheral arterial occlusive disease to enhance stent performance. Nevertheless, the use of dual antiplatelet therapy is associated with an increased incidence (1–2% per annum) of major bleeding complications and is expensive.9,10 The duration of treatment with dual antiplatelet therapy after both coronary and peripheral implantation of DES remains a subject of ongoing debate. Based on emerging evidence, many cardiologists are recommending a minimum of 12 months of aspirin and clopidogrel, but some are advocating indefinite use of dual antiplatelet therapy after DES implantation.11 One year of clopidogrel costs approximately $1,000. This expense is in addition to the cost already incurred by using a DES, which is about four times that of the bare-metal equivalent; one coronary BMS costs $800, while one DES costs up to $2,500.12
The authors take great pleasure in thanking the staff of Flanders Medical Research Program, with special regards to Dr. Koen De Meester for performing the systematic review of the literature and providing substantial support to the writing of the article.
1. Feiring AJ, Wesolowski AA, Lade S. Primary stent-supported angioplasty for treatment of below-knee critical limb ischemia and severe claudication: Early and one-year outcomes. Am Coll Cardiol 2004;44:2307–2314. 2. Siablis D, Kraniotis P, Karnabatidis D, et al. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study. J Endovasc Ther 2005;12:685–695. 3. Scheinert D, Ulrich M, Scheinert S, et al. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions. EuroIntervention 2006;2:169–174. 4. Bosiers M, Deloose K, Verbist J, Peeters P. Percutaneous transluminal angioplasty for treatment of “below-the-knee” critical limb ischemia: Early outcomes following the use of sirolimus-eluting stents. J Cardiovasc Surg (Torino) 2006;47:171–176. 5. Commeau P, Barragan P, Roquebert P. Sirolimus for below the knee lesions: Mid-term results of SiroBTK study. Catheter Cardiovasc Interv 2006;68:793–798. 6. Siablis D, Karnabatidis D, Katsanos K, et al. Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia: Enduring 1-year angiographic and clinical benefit. J Endovasc Ther 2007;14:241–250. 7. Siablis D, Karnabatidis D, Katsanos K, et al. Infrapopliteal application of paclitaxel-eluting stents for critical limb ischemia: Midterm angiographic and clinical results. J Vasc Interv Radiol 2007;18:1351–1361. 8. Sakurai R, Ako J, Morino Y, et al. Predictors of edge stenosis following sirolimus-eluting stent deployment (a quantitative intravascular ultrasound analysis from the SIRIUS trial). Am J Cardiol 2005;96:1251–1253. 9. Diener HC, Bogousslavsky J, Brass LM, et al. Aspirin and clopidogrel compared with clopidogrel alone after recent ischemic stroke or transient ischemic attack in high-risk patients (MATCH): Randomized, double-blind, placebo-controlled trial. Lancet 2004;364:331–337. 10. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2007;297:159–168. 11. Waksman R. Update on bioabsorbable stents: From bench to clinical. J Interv Cardiol 2006;19:414–421. 12. Harper R. Drug-eluting stents coronary stents — a note of caution. Med J Aust 2007;186:253–255.