Comparison of neointimal coverage between ultrathin biodegradable polymer‐coated sirolimus‐eluting stents and durable polymer‐coated everolimus‐eluting stents: 6 months optical coherence tomography follow‐up from the TAXCO study

Abhyankar, Atul; Abizaid, Alexandre; Chamié, Daniel; Rathod, Mihir

doi:10.1002/ccd.28833

Cited by 13 publications

(10 citation statements)

References 31 publications

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“…[152] Another issue is the formation of fibrous tissue capsules, [153] which may interfere with the function of the sensors. [153] Various strategies have been employed to mitigate against inflammation and related problems, including the release of drugs, [154] such as those experimented with the intravascular stents (e.g., Sirolimus) [155] or with orthopedic devices (anti-inflammatory [156] or anti-osteolytic [157] agents). [158] Similarly, these approaches can be used in biodegradable implantable sensors, as long as they do not interfere with the parameters to be measured or affect sensor function adversely.…”

Section: Tissue Responsementioning

confidence: 99%

Biodegradable Implantable Sensors: Materials Design, Fabrication, and Applications

Ashammakhi

Hernández

Unluturk

et al. 2021

Adv Funct Materials

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The ability to monitor diseases, therapies, and their effects on the body is a critical component of modern care and personalized medicine. Real time monitoring can be achieved by analyzing body fluids or by applying sensors on, or alternatively, inside the body. Implantable sensors, however, must be removed. Second removal procedures lead to further tissue damage, which can be a problem in tissues such as those of the central nervous system. The use of biodegradable sensors alleviates these problems since they do not require removal procedures. Recent advances in material science made it possible for all sensor components to be biodegradable. Small size and power of implants, and the limited selection of materials are the main constraints determining the capabilities of the biodegradable device. Thus, the design will be always a challenge exploring a trade-off among these parameters. Despite of the encouraging results illustrating that biodegradable sensors can be as accurate and reliable as commercially available nondegradable ones, biodegradable implantable sensors are still in their infancy. Significant advances made in this area are critically reviewed in this paper, and future prospects are highlighted.

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Section: Tissue Responsementioning

confidence: 99%

Biodegradable Implantable Sensors: Materials Design, Fabrication, and Applications

Ashammakhi

Hernández

Unluturk

et al. 2021

Adv Funct Materials

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“…The sample size calculation required 88 cases which was not met (total available number for primary endpoint analysis was 86 cases). Additionally, the SD of percent strut coverage was very large compared with prior studies 14,29,30 . Thus, we have less power to detect a difference than estimated.…”

Section: Limitationsmentioning

confidence: 70%

Comparison of 6‐month vascular healing response after bioresorbable polymer versus durable polymer drug‐eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study

Noguchi

Dohi

Okazaki

et al. 2021

Cathet Cardio Intervent

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Objectives This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus‐eluting stents (EES) in patients with acute coronary syndromes (ACS). Background Whether BP‐EES induce better vascular healing compared to contemporary DP‐EES remains controversial, especially for ACS. Methods In this prospective, randomized, non‐inferiority trial, we used OCT to compare 6‐month vascular healing in patients with ACS randomized to BP versus DP‐EES: percent strut coverage (primary endpoint, non‐inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated. Results A total of 104 patients with ACS were randomly assigned to BP‐EES (n = 52) versus DP‐EES (n = 52). Of these, 86 patients (40 BP‐EES and 46 DP‐EES) were included in the final OCT analyses. Six‐month percent strut coverage of BP‐EES (83.6 ± 11.4%) was not non‐inferior compared to those of DP‐EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval‐2.6%), pnon‐inferiority = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 μm versus 67.2 ± 33.9 μm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non‐lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005). Conclusions Six‐month strut coverage of BP‐EES was not non‐inferior compared to those of DP‐EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

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“…At 6 months, no significant difference was observed between Xience EES and Tetriflex SES in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137). Strut‐level neointimal thickness was reported to be 0.18 ± 0.12 and 0.14 ± 0.08 mm ( p = .286) in Xience EES and Tetriflex SES, respectively 17 . Nevertheless, it lacked the evaluation of very early healing and neointimal process of the Tetriflex SES at 1 month.…”

Section: Discussionmentioning

confidence: 99%

Healing and early stent coverage after ultrathin strut biodegradable polymer‐coated sirolimus‐eluting stent implantation: SiBi optical coherence tomography study

Abhyankar

Abizaid

Chamié

et al. 2020

Cathet Cardio Intervent

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Aims The aim of SiBi study was to evaluate the early vascular healing and neointimal coverage after implantation of ultrathin (60 μm) biodegradable polymer‐coated Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus‐eluting stent (SES) using optical coherence tomography (OCT) at 4 to 6 weeks after implantation. Methods SiBi was a single‐center, observational, investigator‐initiated study. From January 15, 2018 to April 15, 2018, total 29 consecutive patients who had consented and underwent OCT examination at 4–6 weeks after Tetriflex SES implantation were enrolled. All OCT images were analyzed at an independent core laboratory by analysts who were blinded to patient and procedural information. Results Of 29 patients, four patients were excluded, as those OCT images were technically inadequate for analysis. Therefore, 25 patients were included in final OCT analysis. Average OCT analysis was performed after 35.3 ± 5 days of Tetriflex implantation. Total 14,024 stent struts in 1,520 cross sections were analyzed. Strut tissue coverage was observed in 91.26 ± 5.53% of struts and malapposed struts were seen in 0.89 ± 1.67%. The mean neointimal hyperplasia (NIH) thickness on the covered struts was 50 ± 30 μm. Conclusion A large percentage of struts were found to be covered with thin layer of NIH evenly distributed along the stent length at around 1 month from stent implantation. The results of this pilot study serve as ethical and scientific backbone to conduct an adequately powered clinical trial to evaluate outcomes of short dual‐antiplatelet therapy in context of ultrathin strut stent.

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Comparison of neointimal coverage between ultrathin biodegradable polymer‐coated sirolimus‐eluting stents and durable polymer‐coated everolimus‐eluting stents: 6 months optical coherence tomography follow‐up from the TAXCO study

Cited by 13 publications

References 31 publications

Biodegradable Implantable Sensors: Materials Design, Fabrication, and Applications

Biodegradable Implantable Sensors: Materials Design, Fabrication, and Applications

Comparison of 6‐month vascular healing response after bioresorbable polymer versus durable polymer drug‐eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study

Healing and early stent coverage after ultrathin strut biodegradable polymer‐coated sirolimus‐eluting stent implantation: SiBi optical coherence tomography study

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