Three‐months optical coherence tomography analysis of a biodegradable polymer,sirolimus‐eluting stent |
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| Authors: | Еvgeny Kretov MD PhD Ivan Naryshkin MD Vitaly Baystrukov MD PhD Igor Grazhdankin MD Aleksei Prokhorikhin MD Dmitry Zubarev MD Alexey Biryukov MD PhD Vladimir Verin MD PhD Andrey Boykov MD Dastan Malaev MD Evgeny Pokushalov MD PhD Alexander Romanov MD PhD Martin W. Bergmann MD PhD |
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| Affiliation: | 1. Novosibirsk Scientific Research Institute of Circulation Pathology, Novosibirsk, Russian Federation;2. Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia;3. Primorskiy Regional hospital №1, Vladivostok, Russia;4. Interventional Cardiology, Cardiologicum Hamburg Standort Wandsbek, Hamburg, Germany |
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| Abstract: | Objective We aimed to assess early neointimal healing by optical coherence tomography (OCT) 3 months after implantation of the ultrathin Orsiro® sirolimus‐eluting stent with biodegradable polymer. Background New generations of drug‐eluting stents with biodegradable polymer have been developed to avoid the continued vascular irritation of durable polymers. Methods In this prospective, open‐label study, 34 patients received an Orsiro® sirolimus‐eluting stent with biodegradable polymer. In a subgroup of patients (n = 15), the intervention was performed under OCT guidance. All patients underwent OCT‐examination at three months. The primary endpoint was 3‐month neointimal healing (NIH) score, calculated by weighing the presence of filling defects, malapposed and uncovered struts. Secondary endpoint was maturity of tissue coverage at 3 months. Results At 3 months, NIH score was 13.7 (5.4‐22), covered struts per lesion were 90% (84‐97%), malapposed struts were 2.7% (0.8‐5.4%) and rate of mature tissue coverage was 47% (42‐53%). No target lesion failure occurred up to 12 months. Patients with OCT‐guided stent implantation demonstrated a trend toward earlier stent healing as demonstrated by superior NIH scores (angio guided: 17.6% [8.8‐26.4]; OCT‐guided: 9.8% [4.0‐15.5]; mean difference ?8, [95%CI: ?18.7‐2.9], P = 0.123). This group had significantly more covered struts per lesion (angio‐guided: 86% [82‐90]; 95% [92‐99]; mean difference 9% [95%CI: 3‐15], P = 0.001). Conclusion The Orsiro® sirolimus‐eluting stent with biodegradable polymer shows early vascular healing with a high rate of strut coverage at 3‐month follow‐up. OCT guided stent implantation had a positive impact on early vascular healing. |
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| Keywords: | biodegradable polymer DES OCT |
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