Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study

Valdés‐Chávarri, Mariano; Kedev, Saško; Nešković, Aleksandar N.; Morís, César; Zivkovic, Milan; Trillo-Nouche, Ramiro; González, N.; Bartorelli, Antonio L.; Antoniucci, David; Tamburino, Corrado; Colombo, Antonio; Abizaid, Alexandre; McFadden, Eugène; García‐García, Héctor M.; Stanković, Goran

doi:10.4244/eij-d-17-01087

Cited by 16 publications

(14 citation statements)

References 17 publications

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“…Indeed the majority of definite ST reported in our registry (83%) occurred in STEMI patients within 30 days from the index procedure. Our results are comparable with those obtained from the MASTER trial that reported a 1.9% rate of definite/probable ST at 12‐month follow‐up in STEMI patients treated with Ultimaster BP‐SES . Longer follow‐up are needed to better validate the long‐term efficacy and safety of the Ultimaster BP‐SES in AMI setting.…”

Section: Discussionsupporting

confidence: 84%

“…A prospective analysis of AMI patients included in the SCAAR registry comparing treatment with Synergy BP-EES with a group of newer BP-DES, including Ultimaster BP-SES, showed no differences in the risk of ST (0.69% and 0.81%; p = .99) and ISR (1.48 and 1.25%, p = .72). 18 The recently published randomized MASTER study 13 showed clinical noninferiority and angiographic superiority of the Ultimaster BP-SES compared with BMS in STEMI patients. However, the subgroup analysis of ACS patients included in the CENTURY II trial showed similar safety and efficacy outcomes of the Ultimaster BP-SES as compared with the Xience PP-EES at 24-month follow-up, with respect to TLF (6.3 vs. 6.5%, p = .95), but a numerically albeit not statistically significant higher rate of definite/probable ST was observed with the Ultimaster BP-SES (1.59 vs. 0.72%, p = .51).…”

Section: Discussionmentioning

confidence: 99%

“…Our results are comparable with those obtained from the MASTER trial that reported a 1.9% rate of definite/probable ST at 12-month follow-up in STEMI patients treated with Ultimaster BP-SES. 13 Longer follow-up are needed to better validate the long-term efficacy and safety of the Ultimaster BP-SES in AMI setting.…”

Section: Discussionmentioning

confidence: 99%

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One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry

Moscarella

Ielasi

Beneduce

et al. 2019

Cathet Cardio Intervent

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Background The ULISSE registry has demonstrated the real‐world performance of the Ultimaster biodegradable polymer sirolimus‐eluting stent (BP‐SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). Methods We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non‐AMI). The primary end point was the incidence of 1‐year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV‐MI), and clinically indicated target lesion revascularization (TLR). Results Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non‐ST elevation myocardial infarction, and 174(45.7%) ST‐elevation myocardial infarction. Compared with non‐AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non‐AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22–3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64–7.88; p = .01) and TV‐MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22–7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35–1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. Conclusions In AMI patients, Ultimaster BP‐SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non‐AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

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One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry

Moscarella

Ielasi

Beneduce

et al. 2019

Cathet Cardio Intervent

Self Cite

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“…Therefore, further long-term follow-up is needed to compare the long-term safety and efficacy of BP-SESs with those of other DESs. Ongoing studies have been designed to confirm the efficacy of BP-SESs among patients with acute myocardial infarction (MASTER study at 12 months, BP-SES vs. BMS: target vessel failure, 6.1% vs. 14.4%, p < 0.001) [46] and to investigate their performance in consecutive patients undergoing percutaneous coronary intervention in daily clinical practice (e-ULTIMASTER, NCT02188355).…”

Section: Discussionmentioning

confidence: 99%

Late neointimal volume reduction is observed following biodegradable polymer-based drug eluting stent in porcine model

Ijichi

Nakazawa

Torii

et al. 2021

IJC Heart & Vasculature

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Background The BP-SES has an abluminally applied biodegradable polymer that is fully resorbed after 3–4 months but may have longer-lasting effects. The aim of this study was to determine the long-term vascular response to the novel Ultimaster™ sirolimus-eluting stent (BP-SES). Methods BP-SESs, everolimus-eluting stents (DP-EESs), and bare metal stents were implanted in 22 coronary arteries of 15 mini-swine. All animals underwent optical frequent domain imaging (OFDI) to assess neointimal volume and quality at either 1 (n = 7) or 3 (n = 8) months and at 9 (n = 15) months and were euthanized at 9 months. Stents were subsequently histologically investigated to analyze the vascular response and maturity of neointimal tissue according to cell density. Results OFDI revealed greater regression in neointimal volume from 3 to 9 months with BP-SESs than with DP-EESs (−0.6 ± 0.5 mm 2 vs. 0.00 ± 0.4 mm 2 , p = 0.07). Although there was no significant difference between BP-SESs and DP-EESs in the inflammation score (BMS, BP-SES, and DP-EES: 0.1 ± 0.1, 0.3 ± 0.4, and 0.4 ± 0.4, respectively; p < 0.0001) in histological analysis, BP-SESs showed slightly greater maturity than DP-EESs (1.8 ± 0.3, 1.7 ± 0.3, and 1.6 ± 0.3, p = 0.09). Conclusions While both BP-SESs and DP-EESs showed minimal inflammatory responses at 9 months, BP-SESs showed a trend for greater neointimal maturity and regression, which may be related to earlier completion of the vascular response.

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“…Overall, the present study adds to the numerous published evidence from recent years on excellent performance of Ultimaster (BP‐SES) system. This includes reports of favorable outcomes in general and specific subpopulations, like STEMI patients, bifurcations, long lesions, and small vessels …”

Section: Discussionmentioning

confidence: 99%

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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Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study

Cited by 16 publications

References 17 publications

One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry

One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry

Late neointimal volume reduction is observed following biodegradable polymer-based drug eluting stent in porcine model

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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