Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging

Chevalier, Bernard; Smits, Pieter C.; Carrié, Didier; Mehilli, Julinda; Boven, Ad J. van; Regar, Evelyn; Sawaya, Fadi J.; Chamié, Daniel; Kraaijeveld, Adriaan O.; Hovasse, Thomas; Vlachojannis, Georgios J.

doi:10.1161/circinterventions.116.004801

Cited by 34 publications

(17 citation statements)

References 29 publications

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“…Table 1 summarises the data collected from the included studies. Ten of the 20 studies were randomised control trials (RCT) [ 22 , 23 , 28 , 29 , 32 – 34 , 37 , 39 , 40 ], five were cohort studies [ 25 , 27 , 31 , 36 , 38 ], two were retrospective autopsy studies [ 26 , 35 ], and three were prospective, single-arm trials [ 22 , 24 , 30 ]. Four studies looked at BMS, with one comparing two BMS with varying strut thickness [ 39 ], and three comparing the effects of BMS and DES on ISR rates [ 29 , 32 , 37 ].…”

Section: Resultsmentioning

confidence: 99%

“…Four studies looked at BMS, with one comparing two BMS with varying strut thickness [ 39 ], and three comparing the effects of BMS and DES on ISR rates [ 29 , 32 , 37 ]. Six studies investigated BRS [ 21 , 22 , 24 , 25 , 27 , 38 ], and 19 out of the 20 included studies investigated at least one drug-eluting stent. There were missing data for the scaffold and polymer types used for some studies as well as strut thickness.…”

Section: Resultsmentioning

confidence: 99%

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Critical evaluation of stents in coronary angioplasty: a systematic review

Stevens¹,

Zamani

Osborne³

et al. 2021

BioMed Eng OnLine

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Background Coronary stents are routinely placed in the treatment and prophylaxis of coronary artery disease (CAD). Current coronary stent designs are prone to developing blockages: in-stent thrombosis (IST) and in-stent re-stenosis (ISR). This is a systematic review of the design of current coronary stent models, their structural properties and their modes of application, with a focus on their associated risks of IST and ISR. The primary aim of this review is to identify the best stent design features for reducing the risk of IST and ISR. To review the three major types of stents used in clinical settings today, determining best and relevant clinical practice by exploring which types and features of offer improved patient outcomes regarding coronary angioplasty. This information can potentially be used to increase the success rate of coronary angioplasty and stent technology in the future taking into account costs and benefits. Methods Scientific databases were searched to find studies concerning stents. After the exclusion criteria were applied, 19 of the 3192 searched literature were included in this review. Studies investigating three major types of stent design were found: bare-metal stents (BMS), drug-eluting stents (DES) and bioresorbable stents (BRS). The number of participants varied between 14 and 1264. On average 77.4% were male, with a mean age of 64 years. Results From the findings of these studies, it is clear that DES are superior in reducing the risk of ISR when compared to BMS. Conflicting results do not clarify whether BRS are superior to DES at reducing IST occurrence, although studies into newer BRS technologies show reducing events of IST to 0, creating a promising future for BRS showing them to be non-inferior. Thinner stents were shown to reduce IST rates, due to better re-endothelialisation. Scaffold material has also been shown to play a role with cobalt alloy stents reducing the risk of IST. This study found that thinner stents that release drugs were better at preventing re-blockages. Some dissolvable stents might be better at stopping blood clots blocking the arteries when compared to metal stents. The method and procedure of implanting the stent during coronary angioplasty influences success rate of these stents, meaning stent design is not the only significant factor to consider. Conclusions Positive developments in coronary angioplasty could be made by designing new stents that encompass all the most desirable properties of existing stent technology. Further work is needed to investigate the benefits of BRS in reducing the risk of IST compared to DES, as well as to investigate the effects of different scaffold materials on IST and ISR outcomes.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Critical evaluation of stents in coronary angioplasty: a systematic review

Stevens¹,

Zamani

Osborne³

et al. 2021

BioMed Eng OnLine

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“…The present study demonstrated the comparable coverage percent between BP-DES and DP-DES, which was in line with the previous reports. At 3-month follow-up, the Ultimaster™ BP-DES and the Synergy™ BP-DES achieved similar strut coverage percent of 95.2% and 94.5%, respectively [2,10,11], while the Xience™ DP-DES and the Resolute™ DP-DES also showed the coverage percent of 94.5% and 93.8%, respectively [12,13]. Both previous and the present studies showed comparable neointimal coverage percent after implantation of the contemporary BP-and DP-DESs assessed by OCT.…”

Section: Strut Coverage In the Bp-and The Dp-desmentioning

confidence: 90%

“…3summarizes the results of OCT analysis. Light intensity of superficial neointima in the BP-DES group was lower than that in the DP-DES group (120 2. [102.9, 154.8] vs. 170.9 [117.6, 227.4], p < 0.001), whereas deep neointima in the BP-DES showed comparable to that in the DP-DES.…”

mentioning

confidence: 86%

“…Animal study suggested that the technology may promote a more complete and quick healing process with these stents in acute phase [1]. An imaging study of the Ultimaster™ BP-DES in human presented almost complete coverage of struts at 3-month follow-up on optical coherence tomography (OCT) [2], which might represent the expected early vessel healing. However, precise imaging data of these theoretical benefits of the contemporary BP-DES including strut coverage and neointimal quality in comparison with the current durable polymer DES (DP-DES) is still scarce [3].…”

Section: Introductionmentioning

confidence: 98%

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Neointimal characteristics comparison between biodegradable-polymer and durable-polymer drug-eluting stents: 3-month follow-up optical coherence tomography light property analysis from the RESTORE registry

Kobayashi

Sotomi

Suzuki

et al. 2019

Int J Cardiovasc Imaging

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We aimed to quantitatively assess a possible difference of the neointimal quality between biodegradable polymer-(BP-) and durable polymer drug-eluting stents (DP-DESs). We conducted a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful OCT examination at planned 3-month follow-up after DES implantation were analyzed. Study population was divided into 2 groups, BP-DES versus DP-DES groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter. We performed OCT analyses of 121 lesions in 98 patients (BP-DES 55 lesions in 51 patients vs. DP-DES 66 lesions in DP-DES 53 patients). Lesion and procedural characteristics were overall well-balanced between both groups. At 3-month follow-up, neointimal thickness (BP-DES 49.3 [38.2, 57.7] µm versus DP-DES 54.7 [45.1, 70.7] µm, p = 0.059) and coverage percent (BP-DES 94.5 [89.8, 97.0]% vs. DP-DES 95.8 [91.1, 98.1]%, p = 0.083) did not significantly differ. Light intensity of superficial neointima in the BP-DES was lower than that in the DP-DES, whereas that of deep neointima did not differ between both groups. Both superficial and deep neointima of the BP-DES presented significantly lower light attenuation and backscatter than those of the DP-DES did. Almost complete coverage at 3 months in both contemporary BP-and DP-DES would support the ultra-short DAPT strategy in the upcoming decade. Nevertheless, there was a significant difference in the neointimal characteristics on OCT light property 3 months after BP-versus DP-DES implantation. Trial Registration UMIN000033009.

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Comparison of long‐term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus‐eluting stent or permanent polymer everolimus‐eluting stent: 5‐year results of the CENTURY II randomized clinical trial

Íñiguez

Chevalier

Richardt

et al. 2019

Cathet Cardio Intervent

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Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimuseluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. Background: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. Methods: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. Results: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES Abbreviations: (N)IDDM, (non) insulin-dependent diabetes mellitus; (N)STEMI, (non) ST-segment elevation myocardial infarction; ACC/AHA, Funding information Terumo displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population. K E Y W O R D Sclinical trials, complex PCI, coronary artery disease, drug eluting, percutaneous coronary intervention, stent, stent design/structure/coating

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Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging

Abstract: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843.

Cited by 34 publications

References 29 publications

Critical evaluation of stents in coronary angioplasty: a systematic review

Critical evaluation of stents in coronary angioplasty: a systematic review

Neointimal characteristics comparison between biodegradable-polymer and durable-polymer drug-eluting stents: 3-month follow-up optical coherence tomography light property analysis from the RESTORE registry

Comparison of long‐term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus‐eluting stent or permanent polymer everolimus‐eluting stent: 5‐year results of the CENTURY II randomized clinical trial

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