The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Coronary interventions
Twelve-month outcomes of 400 patients treated with a resorbable metal scaffold: insights from the BIOSOLVE-IV registry
Stefan Verheye1, MD, PhD; Adrian Wlodarczak2, MD; Piero Montorsi3, MD; Johan Bennett4, MD, PhD; Jan Torzewski5, MD; Michael Haude6, MD; Mathias Vrolix7, MD; Thomas Buck8, MD; Adel Aminian9, MD; Rene J. van der Schaaf10, MD; Amin Arrif Nuruddin11, MD; Michael K.Y. Lee12, MD
1. Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium; 2. Miedziowe Centrum Zdrowia S.A., Lublin, Poland; 3. Department of Clinical Sciences and Community Health, University of Milan and Centro Cardiologico Monzino, IRCCS, Milan, Italy; 4. Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium; 5. Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany; 6. Medical Clinic I Städtische Kliniken Neuss Lukaskrankenhaus GmbH, Neuss, Germany; 7. Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; 8. Department of Cardiology, Klinikum Westfalen, Knappschaft KH, Dortmund, Germany; 9. Centre Hospitalier Universitaire de Charleroi, Department of Cardiology, Charleroi, Belgium; 10. Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands; 11. Institute Jantung Negara, Kuala Lumpur, Malaysia; 12. Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong, China
Introduction
Magmaris® (Biotronik AG, Bülach, Switzerland) is a magnesium-based scaffold that has been successfully tested in 184 patients enrolled in the BIOSOLVE-II and BIOSOLVE-III studies [1,2. After gaining CE certification in June 2016, it was paramount to test this device in clinical routine to ensure a safe roll-out of this technology.
Methods
BIOSOLVE-IV is an international, single-arm, multicentre registry conducted in 86 centres. The first patient was enrolled in September 2016. Inclusion and exclusion criteria and endpoints are listed on ClinicalTrials.gov (NCT02817802).
Clinical follow-up was scheduled at six and 12 months, and annually up to five years (...
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