Michael Haude1, MD; Adrian Wlodarczak2, MD; René J van der Schaaf3, MD; Jan Torzewski4, MD; Bert Ferdinande5, MD; Javier Escaned6, MD; Juan F Iglesias7, MD; Johan Bennett8, MD; Gabor G. Toth9, MD; Michael Joner10, MD; Ralph Toelg11, MD; Marcus Wiemer12, MD; Göran Olivecrano13, MD; Paul Vermeersch14, MD; Hector M. Garcia-Garcia15, MD; Ron Waksman15, MD
1. Medical Clinic I, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; 2. Department of Cardiology, Miedziowe Centrum Zdrowia SA, Lubin, Poland; 3. Department of Interventional Cardiology, OLVG, Amsterdam, the Netherlands; 4. Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany; 5. Department of Cardiology, Ziekenhuis Oost Limburg (ZOL), Genk, Belgium; 6. Division of Cardiology, Hospital Clinico San Carlos IdISSC, Complutense University of Madrid, Madrid, Spain; 7. Cardiology Division, University Hospital of Geneva, Geneva, Switzerland; 8. Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium; 9. Division of Cardiology, Medical University Graz, Graz, Austria; 10. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München, Germany, and Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. Partner Site Munich Heart Alliance, Munich, Germany; 11. Cardiology Department, Heart Center Segeberger Kliniken, Bad Segeberg, Germany; 12. Department of Cardiology and Intensive Care, Johannes Wesling University Hospital, Ruhr University Bochum, Minden, Germany; 13. Department of Cardiology, Skåne University Hospital, Lund, Sweden; 14. Interventional Cardiology ZNA Middelheim, Antwerp, Belgium; 15. Interventional Cardiology, MedStar Washington Hospital Center, Washington, D.C., USA
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.
No account yet? Create my pcr account
Sign up for free!
Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases
bioresorbable scaffoldsdrug-eluting stentnstemistable angina
Read next article
Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial