Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

Ellis, Stephen G.; Kereiakes, Dean J.; Metzger, D. Christopher; Caputo, Ronald P.; Rizik, David G.; Teirstein, Paul S.; Litt, Mortimer; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O.; Popma, Jeffrey J.; McGreevy, Robert; Zhang, Zhen; Simonton, Charles A.; Stone, Gregg W.

doi:10.1056/nejmoa1509038

Cited by 580 publications

(353 citation statements)

References 33 publications

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“…Device thrombosis was a little more common in the ABSORB group (1.5% vs 0.7%, p = 0.13), due to subacute thrombosis (between 1 day and 30 days after the procedure). The authors concluded that everolimus-eluting bioresorbable stent was noninferior to everolimus-eluting metallic stent regarding TLF at 1 year (85). Taken together, the ABSORB II and ABSORB III studies showed that everolimus-eluting bioresorbable stent is noninferior to Xience stent in term of TLF, but experts think that it is probably too early to show any advantage of ABSORB stents.…”

Section: Clinical Trialsmentioning

confidence: 99%

“…ABSORB III included 2008 patients with stable and unstable angina randomized to receive an everolimus-eluting bioresorbable scaffold (ABSORB) or an everolimus-eluting cobaltchromium stent (Xience) (85). The primary end point was tested for both noninferiority and superiority and measured TLF at 1 year (85).…”

Section: Clinical Trialsmentioning

confidence: 99%

“…The primary end point was tested for both noninferiority and superiority and measured TLF at 1 year (85). The lesions treated were more complex than in previous study with 68.7% type B2 or C according to the ACC/AHA coronary lesion classification (85).…”

Section: Clinical Trialsmentioning

confidence: 99%

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Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease?

Brie

Penson

Şerban

et al. 2016

International Journal of Cardiology

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ABSTRACT:Today, drug-eluting metal stents are considered the gold standard for interventional treatment of coronary artery disease. While providing inhibition of neointimal hyperplasia, drug-eluting metal stents have many limitations such as the risk of late and very late stent thrombosis, restriction of vascular vasomotion and chronic local inflammatory reaction due to permanent implantation of a 'metallic cage', recognized as a foreign body. Bioresorbable scaffold stents (BRS) are a new solution, which is trying to overcome the limitation of the 'metallic cage'. This structure provides short-term scaffolding of the vessel and then disappears, leaving nothing behind. The purpose of this review is to present the theoretical rationale for the use of BRS and to outline the clinical outcomes associated with their use in terms of data obtained from RCTs, clinical trials, registries and real life use. We have also tried to answer all questions on this intervention based on available data, with a focus on ABSORB BVS (Abbott Vascular, Santa Clara, USA). We consider that this new technology can be the "magic bullet" to treat coronary artery disease.

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Section: Clinical Trialsmentioning

confidence: 99%

Section: Clinical Trialsmentioning

confidence: 99%

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Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease?

Brie

Penson

Şerban

et al. 2016

International Journal of Cardiology

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“…In the 1‐year result of the ABSORB III randomized clinical trial, everolimus‐eluting bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular, Santa Clara, CA) showed noninferiority for target lesion failure compared with the everolimus‐eluting Xience drug‐eluting stent (Abbott Vascular, Santa Clara, CA) 3. However, a recent ABSORB II trial did not meet its primary end point of superior vasomotor reactivity and larger late lumen loss in Absorb BVS at 3 years after implantation, compared with the Xience drug‐eluting stent 4.…”

Section: Introductionmentioning

confidence: 99%

“…From these preclinical studies, it is clear that slow degradation of polymeric BRS was considered safe and was associated with mild inflammation 6, 7. However, a more rapid onset of degradation may facilitate early vessel remodeling and luminal gain during the course of vascular healing and consequently may decrease detrimental vascular effects that have recently been reported over the long term in man 3, 4…”

Section: Introductionmentioning

confidence: 99%

Comparison of a Drug‐Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3‐Year Follow‐Up

Yahagi

Yang

Torii

et al. 2017

JAHA

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BackgroundArterial Remodeling Technologies bioresorbable scaffold (ART‐BRS), composed of l‐ and d‐lactyl units without drug, has shown its safety in a porcine coronary model at 6 months. However, long‐term performance remains unknown. The aim of this study was to evaluate the ART‐BRS compared to a bare metal stent (BMS) in a healthy porcine coronary model for up to 3 years.Methods and ResultsEighty‐two ART‐BRS and 66 BMS were implanted in 64 Yucatan swine, and animals were euthanatized at intervals of 1, 3, 6, 9, 12, 18, 24, and 36 months to determine the vascular response using quantitative coronary angiography, optical coherence tomography, light and scanning electron microscopy, and molecular weight analysis. Lumen enlargement was observed in ART‐BRS as early as 3 months, which progressively increased up to 18 months, whereas BMS showed no significant difference over time. Percentage area stenosis by optical coherence tomography was greater in ART‐BRS than in BMS at 1 and 3 months, but this relationship reversed beyond 3 months. Inflammation peaked at 6 months and thereafter continued to decrease up to 36 months. Complete re‐endothelialization was observed at 1 month following implantation in both ART‐BRS and BMS. Scaffold dismantling started at 3 months, which allowed early vessel enlargement, and bioresorption was complete by 24 months.Conclusions ART‐BRS has the unique quality of early programmed dismantling accompanied by vessel lumen enlargement with mild to moderate inflammation. The main distinguishing feature of the ART‐BRS from other scaffolds made from poly‐l‐lactic acid may result in early and long‐term vascular restoration.

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Percutaneous Coronary Intervention With Bioresorbable Scaffolds in a Young Child

et al. 2017

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Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

Cited by 580 publications

References 33 publications

Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease?

Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease?

Comparison of a Drug‐Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3‐Year Follow‐Up

Percutaneous Coronary Intervention With Bioresorbable Scaffolds in a Young Child

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