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.
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