A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus

Romaguera, Rafael; Gómez‐Hospital, Joan Antoni; Gomez‐Lara, Josep; Brugaletta, Salvatore; Pinar, Eduardo; Jiménez‐Quevedo, Pilar; Gracida, Montserrat; Roura, Gerard; Ferreiro, José Luis; Teruel, Luís; Montanya, Eduard; Fernández‐Ortíz, Antonio; Alfonso, Fernándo; Valgimigli, Marco; Sabaté, Manel; Cequier, Ángel

doi:10.1016/j.jcin.2015.09.020

Cited by 72 publications

(54 citation statements)

References 41 publications

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“…This is somewhat higher than in other studies investigating patients with diabetes. For example in the SPIRIT V diabetic study, late loss was 0.19 mm; in the RESORVOIR study, 0.24 mm with everolimus-eluting stent [8, 26]. Although the reasons for this are unclear, this may be related to baseline patient and lesion complexity: the inclusion criteria in our study were broader and exclusion criteria were fewer.…”

Section: Discussionmentioning

confidence: 89%

“…Against this background polymer-free DES showed non-inferior short-term angiographic outcomes in comparison with a durable polymer-based everolimus-eluting stent in the setting of diabetic patients [8]. However, the efficacy and safety of polymer-free DES compared with durable polymer-based second-generation DES in diabetic patients are poorly defined and very long-term outcomes are underexplored with data almost exclusively deriving from comparison with outdated first-generation polymer-based DES [9].…”

Section: Introductionmentioning

confidence: 99%

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Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial

Harada

Colleran

Kufner

et al. 2016

Cardiovasc Diabetol

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Background: Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimusand probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus-and probucol-eluting versus zotarolimus-eluting stents 5 trial.Methods: In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus-and probucoleluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a deviceoriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.Results: A total of 870 patients with diabetes mellitus were treated with either a sirolimus-and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus-and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus-and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52).

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial

Harada

Colleran

Kufner

et al. 2016

Cardiovasc Diabetol

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“…Результаты ис-пользования одного из них у больных СД и с одно-и двухсосудистым поражением изучены в исследовании RESERVOIR [23]. Речь идет о амфилимус-покрытом стенте, изготовленном на основе кобальт-хромиевого сплава с ультратонким пассивным карбоновым покры-тием.…”

Section: сахарный диабет Diabetes Mellitusunclassified

Myocardial revascularization in patients with type 2 diabetes mellitus: An overview of modern techniques

Golukhova¹,

Kuznetsova²

2016

Diabetes mellitus

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КардиологияCardiology сновной причиной летальности в мире про-должают оставаться сердечно-сосудистые за-болевания (ССЗ). По данным Всемирной Организации Здравоохранения, ежегодно от сердечно-сосудистых заболеваний умирают около 17 млн человек, что составляет 29% от всех случаев смерти в мире [1].Многочисленные исследования показали, что сахар-ный диабет (СД) является независимым фактором риска развития и прогрессирования атеросклероза сосудов и значимо повышает риски развития кардиоваскулярных событий [2,3].По последним данным, численность больных СД в мире за последние 10 лет увеличилась более чем в 2 раза и к концу 2014 г. достигла 387 млн человек [4].Согласно данным Государственного регистра боль-ных СД, на 1 января 2015 г. в России зарегистрировано 4,1 млн случаев (данные на 1 января 2014 -3,9 млн), из них число больных СД 2 типа (CД2) составило 3,7 млн [5]. Между тем, по данным эпидемиологических исследований, выполненных в период 2002-2010 гг. в ФГБУ «Эндокринологический научный центр» МЗ, истинная распространенность данного заболевания в 3-4 раза была выше официально зарегистрированного числа больных и достигала 9-10 млн случаев, что со-ставляет около 7% населения. СД в 4 раза увеличивает риск развития ишемической болезни сердца (ИБС) и об-уславливает три четверти связанных с диабетом леталь-ных исходов [2]. У больных ИБС и СД часто выявляется Реваскуляризация миокарда у больных ИБС в сочетании с сахарным диабетом 2 типа: обзор современных технологий © Голухова Е.З., Кузнецова Е.В. ФГБУ

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“…focused on patients with DM. 17 A meta-analysis of 42 trials comparing sirolimus, paclitaxel, everolimus and zotarolimus-eluting DES in diabetic patients, with 22,844 patient years of follow-up, concluded that there was no increased risk of any safety outcome (including very late stent thrombosis) with any DES compared with BMS, and that the EES was the most efficacious and safe of available DES. 18 The study concluded that there was an 87 % probability that EES are the most efficacious DES compared with the others and a 62 % probability that they were the least likely to develop stent thrombosis.…”

Section: The Cre8 Drug Eluting Stentmentioning

confidence: 99%

The Use of the Cre8 Stent in Patients with Diabetes Mellitus

Carrié

2016

Interventional Cardiology Review

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CoronaryAccording to the International Diabetes Federation, 382 million people had diabetes in 2013, with diabetes mellitus (DM) accounting for around 90 % of all diabetes cases. By 2025 the number will rise to 592 million. 1 The association between DM and cardiovascular disease is well established 2 and percutaneous coronary intervention (PCI) is associated with worse clinical and angiographic outcomes among the diabetic patient population than among non-diabetics. 3 Despite improvements in interventional techniques and advances in stent technology, this difference in outcomes persists. There is a greater likelihood of restenosis after PCI with drug eluting stent (DES) implantation in diabetic patients, particularly occlusive restenosis. 4,5 There is also a higher risk of adverse cardiac events in diabetic patients who undergo DES implantation compared with those who undergo coronary artery bypass grafting (CABG).6-8 Second-generation DES provide superior safety and efficacy results compared with first generation DES and have been successfully used in diabetic patients, 9-12 but unmet needs remain in coronary interventions in this growing patient population, leading to the hypothesis that patients with DM need a specialised DES. This article aims to review the clinical evidence in support of the Cre8™ DES in patients with DM. The Cre8 Drug Eluting StentThe Cre8 DES is polymer-free, eliminating the disadvantages associated with durable and absorbable polymers or their breakdown products.Its drug release system (Abluminal Reservoir Technology) features reservoirs on the outer surface of the stent. These enable controlled drug elution that is directed towards the vessel wall (see Figure 1).The Amphilimus™ carrier, comprising sirolimus and an organic acid, enhances drug bioavailability. 13 Its optimised permeability allows a homogeneous distribution inside the vessel wall and a uniform action on the whole tissue, enabling an optimal balance between safety and efficacy. The effects of sirolimus are dose dependent; in diabetic patients, more sirolimus is needed to achieve the equivalent anti-proliferative action in healthy cells.14 The organic acid of the Amphilimus formulation increases the permeation of the sirolimus into the cells of diabetic patients. After drug release, a bare metal stent (BMS) remains. The Cre8 DES is covered with a bio inducer surface made of pure carbon, which is biocompatible and does not produce any late inflammatory stimuli inside the treated segment, reducing the inflammatory response and lowering the risk of stent thrombosis. Clinical Studies Evaluating the Efficacy and Safety of the Cre8 StentInitial clinical data in support of the efficacy of the Cre8 DES came from the International randomised comparison between DES Limus Carbostent and Taxus drug-eluting stents in the treatment of de novo coronary lesions (NEXT) clinical study, which demonstrated the noninferiority of the Cre8 DES versus a permanent-polymer paclitaxeleluting stent. The primary endpoint was 6-month angiographic in-s...

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A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus

Cited by 72 publications

References 41 publications

Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial

Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial

Myocardial revascularization in patients with type 2 diabetes mellitus: An overview of modern techniques

The Use of the Cre8 Stent in Patients with Diabetes Mellitus

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