Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study.

Background

A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents.

Methods

This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153).

Findings

Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preservation of the scaffold area (mean 7.59 mm

Interpretation

These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents.

Funding

This study was funded by BIOTRONIK AG.

Informations de copyright

© 2023 The Author(s).

Déclaration de conflit d'intérêts

MH reports grants/contracts from Biotronik, Cardiac Dimensions, Orbus Neich and Philips, consulting fees from Biotronik, Cardiac Dimensions, and Obrus Neich, honoraria/speaker fees from Biotronik, Cardiac Dimensions, Orbus Neich and Philips, support to attend meetings/travel support from Biotronik, is a steering committee member of the BIOSOLVE and BIOMAG trials, and is a past president of EAPCI. JT reports speaker honoraria and support for attending meetings from Biotronik, and is an associated editor of Cardiovascular Biologics and Regenerative Medicine, JE reports speaker honoraria from Abbott, Boston Scientific, Philips and Shockwave and participation in advisory boards of Abbott, Phillips and Shockwave, the institution of JI receives grants or contracts from Terumo Corp, Biosensors, Concept Medical, Biotronik, Abbott Vascular, Philips Volcano, JI reports consulting fees from Biotronik, Medtronic, Cordis, and Terumo Corp and speaker fees from Terumo Corp, Biosensors, Medalliance, Orbus Neich, Concept Medical, Bristol Myers Squibb/Pfizer, Novartis, Cordis, AstraZeneca, and Philips Volcano, and support to attend meetings from Biotronik and Amgen, the institution of JB receives grants or contracts from Shockwave IVLS, receives consulting fees from Biotronik AG and Boston Scientific, speaker fees from Biotronik AG, Boston Scientific and Abbott Vascular, JB participates in the DSMB of Boston Scientific and has a leadership or fiduciary role for Biotronik, MJ reports grant support from Boston Scientific, Cardiac Dimensions, Edwards LifeSciences and Infraredx, consulting fees from Biotronik, TriCares, Veryan and Shockwave, speaker fees/honoraria from Abbott Vascular, Biotronik, Boston Scientific, Edwards LifeSciences, Cardiac Dimensions, AstraZeneca, Recor Medical, and Shockwave, travel support from SIS Medical, Edwards Lifesciences, Boston Scientific and Cardiac Dimensions, and participation in Steering Committees of Biotronik and Edwards Lifesciences, MW reports speaker honoraria and conference attendance support from Biotronik, GO reports lecturer honoraria from Abbott Vascular, Biotronik and Cordis and is a DSMB member of the SCIENCE trial and a CEC-member of the BIOFREEDOM STEMI trial, HGG has grants or contracts from Medtronic, Biotronik, Abbott, Neovasc, Corflow, Alucentbio, Philips, Chiesi (paid to institution), received consulting fees from Boston Scientific and ACIST, participates in DSMB/advisory board of the VIVID study, RW has grants or contracts from Astra Zeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT, and received consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi. Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, andVenous MedTech, receives honoraria from AstraZeneca, participates in DSMB/advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd, and is an investor from MedAlliance and Transmural Systems Inc. All other authors have no conflict of interest to declare.