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Clinical Trial
. 2023 Aug 7;19(5):e414-e422.
doi: 10.4244/EIJ-D-23-00326.

A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study

Michael Haude  1 , Adrian Wlodarczak  2 , René J van der Schaaf  3 , Jan Torzewski  4 , Bert Ferdinande  5 , Javier Escaned  6 , Juan F Iglesias  7 , Johan Bennett  8 , Gabor G Toth  9 , Michael Joner  10 , Ralph Toelg  11 , Marcus Wiemer  12 , Göran Olivecrano  13 , Paul Vermeersch  14 , Hector M Garcia-Garcia  15 , Ron Waksman  15
Affiliations
Clinical Trial

A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study

Michael Haude et al. EuroIntervention. .

Abstract

Background: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES).

Aims: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold.

Methods: This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years.

Results: A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent.

Conclusions: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES.

Clinicaltrials: gov: NCT04157153.

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Conflict of interest statement

H.M. Garcia-Garcia and R. Waksman were core laboratory members, the remaining authors were investigators of the trial. M. Haude reports grants/contracts from Biotronik, Cardiac Dimensions, OrbusNeich, and Philips; consulting fees from Biotronik, Cardiac Dimensions, Shockwave Medical, and OrbusNeich; honoraria/speaker fees from Biotronik, Cardiac Dimensions, Shockwave Medical, OrbusNeich, 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. J. Torzewski reports grants and contracts from Abbott paid to his institution; speaker honoraria and support for attending meetings from Biotronik; and is an associate editor of Cardiovascular Biologics and Regenerative Medicine and Frontiers in Cardiovascular Medicine. J. Escaned reports personal fees/speaker honoraria from Abbott, Boston Scientific, Philips, and Shockwave; has patents from Shared Medical; and is on the advisory boards of Abbott and Philips. J. Iglesias’ institution receives grants or contracts from Terumo, Biosensors, Concept Medical, Biotronik, Abbott Vascular, and Philips/Volcano. J. Iglesias reports consulting fees from Biotronik, Medtronic, Cordis, Terumo, and ReCor Medical; speaker fees/honoraria from Terumo Corp, Biosensors, MedAlliance, OrbusNeich, Concept Medical, Bristol-Myers Squibb/Pfizer, Novartis, Cordis, AstraZeneca, and Philips/Volcano; and support to attend meetings from Biotronik and Amgen. J. Bennett’s institution receives grants or contracts from Shockwave IVLS. J. Bennett receives consulting fees from Biotronik AG and Boston Scientific; speaker fees/honoraria from Biotronik AG, Boston Scientific, and Abbott Vascular; participates in the DSMB of Boston Scientific; and has a leadership or fiduciary role for Biotronik. G. Toth reports consulting fees from Biotronik, Medtronic, Abbott, and Terumo; and honoraria from Biotronik, Medtronic, Abbott Vascular, and Terumo. M. Joner reports grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from Alchimedics SAS, 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 the steering committees of Biotronik and Edwards Lifesciences. R. Toelg reports lecture fees from Biotronik. M. Wiemer reports speaker honoraria and conference attendance support from Biotronik. G. Olivecrona reports lecturer honoraria from Abbott Vascular, Biotronik, and Cordis; is a DSMB member of the SCIENCE trial; and a CEC member of the BIOFREEDOM STEMI trial. H.M. Garcia-Garcia has grants or contracts from Medtronic, Biotronik, Abbott, Neovasc, Corflow, Alucentbio, Philips, and Chiesi (paid to the institution); received consulting fees from Boston Scientific and ACIST; and participates in the DSMB/advisory board of the VIVID study. R. Waksman has grants or contracts from Amgen, Biotronik, Boston Scientific, Medtronic, and Philips IGT; received consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; received honoraria from AstraZeneca; participates in DSMB/advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia; and is an investor in MedAlliance and Transmural Systems, Inc. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Patient flowchart.
A total of 116 patients with 117 lesions were enrolled. At 12 months, serial data (reflecting preprocedure, post-procedure and 6 and 12 months) were available for 100 lesions with angiographic follow-up, 75 lesions with intravascular ultrasound (IVUS) follow-up and for 89 lesions with optical coherence tomography (OCT) follow-up. F/U: follow-up

Figure 2
Figure 2. Serial area changes by intravascular ultrasound.
Paired intravascular ultrasound data were available for 75 patients (core laboratory analysed). The mean lumen area and the mean scaffold area are nearly identical. Subsequently the different curves are not discernible. Δ indicates the difference between follow-ups in mm2 [95% CI]. Δ* refers to post-procedure versus six months, and Δ** refers to 6 months versus 12 months. CI: confidence interval; NIH: neointimal hyperplasia
Central illustration
Central illustration. Optical coherence tomography of strut apposition and absorption, and in-device late lumen loss measured by quantitative coronary angiography.
A) Optical coherence tomography showed good postprocedural strut apposition and that the struts were no longer discernible at 12 months. B) The in-scaffold late lumen loss (LLL) improved by 38% compared to the precursor of DREAMS 3G, the DREAMS 2G, in the BIOSOLVE-II study.
Figure 3
Figure 3. Target lesion failure at 12 months per Kaplan-Meier analysis.
All 3 target lesion failures were clinically driven target lesion revascularisations; no target vessel myocardial infarction nor cardiac death was reported. TLF: target lesion failure
See this image and copyright information in PMC

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