24-Month Clinical Follow-Up and Mechanistic Insights From Intravascular Imaging Following Coronary Implantation of the Novel DynamX Bioadaptor Platform

Verheye, Stefan; Morice, Marie‐Claude; Zivelonghi, Carlo; Mehmedbegovic, Z; Bhat, Vinayak; Colombo, Antonio

doi:10.1016/j.carrev.2022.09.009

Cited by 9 publications

(3 citation statements)

References 24 publications

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“…Thus, the DynamX Bioadaptor is the first permanent coronary artery implant designed to improve vessel function and physiology. The ability to improve the vessel function through disengagement of the uncaging elements was demonstrated at 9- to 12-month imaging follow-up [ 9 , 10 , 11 ] through:…”

Section: Discussionmentioning

confidence: 99%

“…Secondary endpoints at 3 years are TLF at other time points, target-vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and clinically-driven target vessel revascularization (CD-TVR); mortality, myocardial infarction (target-vessel and overall); clinically-driven target lesion revascularization (CD-TLR); overall TLR; CD-TVR; overall TVR; and definite or probable device thrombosis. Imaging endpoints have been reported previously [ 9 , 11 ]. Myocardial infarction was defined as enzyme elevation of 2-times upper normal limit of creatinine kinase (CK) with an elevation of CK-MB; cardiac death, revascularization and device thrombosis were adjudicated according to Academic Research Consortium criteria [ 14 ].…”

Section: Methodsmentioning

confidence: 99%

“…The DynamX Mechanistic study was initiated to evaluate the safety and performance of the DynamX Bioadaptor System in patients with de novo coronary artery lesions by assessing both clinical and imaging outcomes. Clinical and imaging outcomes out to two years have been published previously [ 9 , 11 ], we herein report the final 36-month data.…”

Section: Introductionmentioning

confidence: 99%

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Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data

Verheye¹,

Vrolix²,

Montorfano³

et al. 2023

Rev. Cardiovasc. Med.

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Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 1.31 at baseline to 8.46 1.31 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: : NCT03429894.

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Section: Discussionmentioning

confidence: 99%