Abstract
Purpose
Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy.
Methods
Ten uncoated NS and six TiNOX-coated NS (5–6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimal luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months.
Results
Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into “normal-sized” (stent-to-artery-ratio < 1.4, n = 12) and “oversized” (stent-to-artery-ratio ≥ 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS.
Conclusions
TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.
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Acknowledgments
The study was supported by an unrestricted grant of Hexacath SA, Paris, France. The authors thank O. Beslac for expert technical assistance. This work is dedicated to our mentor, Otto M. Hess, who is deeply missed.
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The authors do not have any conflicts of interest to report.
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Otto M. Hess—deceased.
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Saguner, A.M., Traupe, T., Räber, L. et al. Oversizing and Restenosis with Self-Expanding Stents in Iliofemoral Arteries. Cardiovasc Intervent Radiol 35, 906–913 (2012). https://doi.org/10.1007/s00270-011-0275-y
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DOI: https://doi.org/10.1007/s00270-011-0275-y