Should ultrathin strut drug eluting stents be considered the new benchmark for novel coronary stents approval? The complex interplay between stent strut thickness, polymeric carriers and antiproliferative drugs

Lupi, Alessandro; Schaffer, Alon; Bongo, Angelo Sante

doi:10.21037/jtd.2018.01.108

Cited by 8 publications

(8 citation statements)

References 23 publications

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“…It has proven through ISAR STEREO II study that the thin struts give better results in term of restenosis when compared to thick strut stents (17.9% vs. 31.4%). 16 Replacement of 316L stainless steel (SS) with a cobalt-based alloy is advantageous in many aspects. Firstly, CoCr is stronger in term of yield strength (76% stronger) than SS which helps in establishment of thinner struts without decreasing radial strength.…”

Section: Discussionmentioning

confidence: 99%

Clinical Evaluation of the Indigenously Manufactured Rejuvenate® Bare Metal Stent System in Pakistani Patients With Coronary Artery Disease

Kayani¹,

Rizvi

Niazi³

et al. 2021

Pak Heart J

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Objectives: The aim of this pilot study was the ﬁrst-in-man evaluation of the safety, feasibility, deliverability, and efficiency of the newly developed REJUVENATE® bare metal stent system in coronary artery disease. Methodology: Current study was a pilot non-randomized, multi-centric and prospective study which was intended to study the safety of the REJUVENATE® bare metal stent in Pakistani population over 10 months. Study endpoints included target vessel related myocardial infarction, stent thrombosis, in-stent restenosis, stroke and death. The diameter of the target lesions selected was between 3-4mm with length no more than 22mm. Only one BMS was implanted per patient. These patients had well defined regular clinical follow-ups and CT scan coronary angiography at the end of 10 months. Results: 20 patients suffering from coronary artery disease (CAD) including15 male subjects and 5 female subjects were enrolled in this study and were treated with REJUVENATE® BMS. 65% patients were hypertensive, 25% diabetics and 25% were active smokers. Out of the 20 stents implanted, 14 stents were implanted in the right coronary artery and 6 were implanted in the left circumflex artery. During this 10-month study period there was 10.65% of cases in which late lumen loss (lumen stenosis <70%) was observed, however no cases of in stent restenosis and stent thrombosis were observed. There was no target vessel related myocardial infarction or stroke as well. One patient died of pneumonia during the follow up period. Conclusion: The current study demonstrated the deliverability and clinical safety of REJUVENATE® bare metal stent over a period of 10 months.

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Section: Discussionmentioning

confidence: 99%

Clinical Evaluation of the Indigenously Manufactured Rejuvenate® Bare Metal Stent System in Pakistani Patients With Coronary Artery Disease

Kayani¹,

Rizvi

Niazi³

et al. 2021

Pak Heart J

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“…28 The strut thickness is closely allied with local inflammation at the lesion and, when the thickness is greater, it poses as an obstacle to stent strut coverage with neointima. 29 Collectively, these all have an impact on vascular healing and correlate to the safety and performance of the implanted stent. 6 But, strut thickness tends to be a prime deciding factor for the duration…”

Section: Discussionmentioning

confidence: 99%

“…They added that strut width defined the area of stent adhering to the wall that initiate vascular response, while strut thickness was mostly responsible for the duration of neointima proliferation 28 . The strut thickness is closely allied with local inflammation at the lesion and, when the thickness is greater, it poses as an obstacle to stent strut coverage with neointima 29 . Collectively, these all have an impact on vascular healing and correlate to the safety and performance of the implanted stent 6 .…”

Section: Discussionmentioning

confidence: 99%

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

Abhyankar¹,

Abizaid

Chamié

et al. 2020

Cathet Cardio Intervent

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Aim: The TAXCO study was designed to compare the degree of neointimal coverage and the prevalence of malapposition at 6 months subsequent to implantation of ultrathin biodegradable polymer-coated sirolimus-eluting stents (SES) and durable polymer-coated everolimus-eluting stents (EES) of thin strut thickness using optical coherence tomography (OCT). Methods: The TAXCO study included a total of 42 patients who gave consent and underwent OCT examination between August 2017 and September 2017. Of 42, five patients' OCT examinations were of insufficient quality for quantitative analysis. Thus, the OCT analysis group consisted of 37 patients. Among them, 16 patients were treated with Xience (Abbott Vascular) and 21 with Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), 6 (±1) months earlier at our institution. The OCT was performed using a C7 Dragonfly™ imaging catheter (St. Jude Medical Inc.). All OCT images were analyzed at an independent core laboratory (Cardiovascular Research Center, São Paulo, Brazil) by analysts who were blinded to patient and procedural information. Results: A total of 763 crosssections (6,882 struts) were analyzed in Xience group, and 1,127 crosssections (9,968 struts) in Tetriflex group. At 6 months, on per-lesion basis, no significant differences were observed between Xience group and Tetriflex group in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137) and malapposed struts (0.05 ± 0.2 vs. 0.21 ± 0.69, p = .302). Strut-level neointimal thickness also did not differ between Xience group and Tetriflex group (0.18 ± 0.12 vs. 0.14 ± 0.08 mm, p = .286). Conclusion: This OCT study found no significant difference in strut coverage and neointimal thickness at 6 months after implantation of biodegradable polymer-coated Tetriflex, when compared with durable polymer-coated Xience.

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“…There was a positive correlation shown for Late Lumen Loss (LLL) with strut thickness in a meta-regression study. However, it should be noted that too much reduction in stent strut thickness might weaken the stent platform that can make it prone to longitudinal deformation, which is a problem that can only be partially offset by improvement in stent design [3].…”

Section: Stent-based Drug Deliverymentioning

confidence: 99%

“…Several clinical studies have confirmed the safety and efficacy of "limus family" and, especially, sirolimus has shown encouraging results in terms of LLL, binary Restenosis and late stent thrombosis. Actually, it still represents an ideal choice on the common final pathway of cell division cycle without excessive risks of inducing necrosis [3].…”

Section: Crimson Publishersmentioning

confidence: 99%

Recent Advances in the Local Drug Delivery for the Treatment of Restenosis

Khatri

2018

MADD

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Stent procedure and balloon angioplasty are two major approaches used in the treatment of Cardio vascular diseases. There have been significant advances in the treatment of these disorders and complication resulting from these treatment options i.e. Restenosis. This article focuses on the evolution and the recent advances in the different treatment options available for the preventing Restenosis after vascular intervention. The focal point of this review is the approaches for a localized drug delivery in the vascular walls.

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Should ultrathin strut drug eluting stents be considered the new benchmark for novel coronary stents approval? The complex interplay between stent strut thickness, polymeric carriers and antiproliferative drugs

Cited by 8 publications

References 23 publications

Clinical Evaluation of the Indigenously Manufactured Rejuvenate® Bare Metal Stent System in Pakistani Patients With Coronary Artery Disease

Clinical Evaluation of the Indigenously Manufactured Rejuvenate® Bare Metal Stent System in Pakistani Patients With Coronary Artery Disease

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

Recent Advances in the Local Drug Delivery for the Treatment of Restenosis

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