Drug-Eluting Stents and Drug-Coated Balloons in Peripheral Interventions
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Author Affiliations:
From the Department of Angiology, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany (TZ) and the Department of Diagnostic and Interventional Radiology, University Tuebingen, Germany.
Correspondence: Dr. Thomas Zeller, Herz-Zentrum Bad Krozingen, Südring 15, D-79189 Bad Krozingen, Germany. E-mail address: thomas.zeller@herzzentrum.de.
Manuscript submitted July 17, 2008, provisional acceptance given August 18, 2008, manuscript accepted September 5, 2008.
Disclosure: The authors report no financial relationships or conflicts of interest regarding the content therein.
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Abstract
In the coronaries, the role of drug-eluting stents (DES) is already well defined. However, in the peripheral arteries very limited data exists about their potential benefit. A small randomized study on superficial femoral artery (SFA) lesions comparing bare nitinol stents with short-time sirolimus-eluting nitinol stents resulted in no benefit for the DES group. Two different approaches are still under evaluation, one registry and randomized study investigating the effect of short time release of paclitaxel (the Zilver PTX global registry and the Phase 2 Zilver PTX clinical randomized trial), and another registry evaluating the outcome of SFA treatment using long-term drug release of everolimus (STRIDES). Due to different study protocols, these studies will be difficult to compare. The experience with DES below-the-knee (BTK) is also still limited. Four single-center reports suggest a beneficial outcome of the drug-eluting Cypher stent regarding patency and clinical outcome. Data from multicenter randomized studies are still pending.
A randomized study investigating the value of short-time paclitaxel release using a drug-coated balloon gave promising results, with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions. Below-the-knee, this promising concept is still under evaluation (PICCOLO study).
This article gives an overview of published data and ongoing trials on drug-releasing concepts in the peripheral arteries.
Drug-Eluting Stents and Drug-Coated Balloons in the Superficial Femoral Artery
Percutaneous transluminal balloon angioplasty for revascularization of the superficial femoral artery (SFA) has an initial technical success rate of more than 95%.1 However, restenosis occurs in 40–60% of the treated segments after 6 to 12 months.2–4 Compared to other vascular beds, such as the coronary arteries and the renal arteries, the restenosis rate is much higher in the SFA.5 Furthermore, the benefit of a stent depends on the type of stent, and long-term patency rates will be confirmed last (but not least) in the lower extremity, because of stent fractures.6–9 Several other attempts to increase long-term patency have failed.
Drug-eluting stents. The only study which reported local drug delivery in the SFA was the Sirolimus-Coated Cordis Self-Expandable Stent (SIROCCO) trial, in which sirolimus-coated stents were not significantly superior to uncoated stents.8–10 In the SIROCCO I trial, including 36 patients randomized either to the Smart nitinol (bare stent) or to the sirolimus-eluting Smart stent, Duda et al showed that it is safe and feasible to use sirolimus-eluting Smart (Cordis, Johnson & Johnson, Miami Lakes, Florida) stents for the treatment of obstructive SFA disease.8 After 6 months, the primary endpoint angiographic binary instent restenosis rate was 0% for the drug-eluting stent (DES) versus 17.6% for the bare nitinol stent. This difference was not statistically significant, due to a much better performance of the bare nitinol stent group, as expected. This study was the first one to raise the issue of stent fractures in lesions treated with 3 overlapping stents.
Consequently, in the SIROCCO II trial, in which the investigators evaluated the efficacy of the slow-release, sirolimus-eluting stent (SES) in a larger number of patients (n = 54), only two stents were allowed to be placed, leading to a reduction of the maximum lesion length from 20 cm in SIROCCO I to 14.5 cm (average lesion length was 8.1 cm). After 6 months, again, the DES group did extremely well, with a binary instent restenosis rate of 0%, representing the primary study endpoint. This was probably due to the reduced maximum lesion length. The bare nitinol stent group resulted in a binary restenosis rate of only 7.7%, again failing to show any statistically significant difference in any of the predefined study endpoints.9 After 24 months, primary patency rates for both study groups were virtually the same (DES group: 76%, bare nitinol stent group: 75%).10 Interestingly, stent occlusions occurred only in the bare nitinol stent group. By limiting the number of stents used per lesion from 3 to 2, the stent fracture rate after 6 months was reduced from 18% in the SIROCCO I study to 8% in the SIROCCO II study.
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