Safety and performance of a resorbable magnesium scaffold under real-world conditions: 12-month outcomes of the first 400 patients enrolled in the BIOSOLVE-IV registry
EuroIntervention 2019; just accepted article published in January 2019. DOI: 10.4244/EIJ-D-18-01058
Stefan Verheye1; Adrian Wlodarczak2; Piero Montorsi3; Johan Bennett4; Jan Torzewski5; Michael Haude6; Mathias Vrolix7; Thomas Buck8; Adel Aminian9; Rene J van der Schaaf10; Amin Arrif Nuruddin11; Michael K Y Lee12;
1. Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium, 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
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Aims: We aimed to assess the safety and performance of the Magmaris bioresorbable magnesium scaffold in a large patient population.
Methods and results: BIOSOLVE-IV is an international, single arm, multi-center registry. This is the pre-defined report on 12-month outcomes of the first 400 out of 2054 patients planned. Mean patient age was 62.0±11.0 years and 15.8% (n=63) had non-ST-elevation myocardial infarction. Lesions (n=425) were 3.3±0.3 mm in diameter and 14.5±4.1 mm long. The primary endpoint, target lesion failure at 12 months, occurred in 4.3% [95%CI:2.7;6.9], consisting of 4.3% target lesion revascularizations, 0% cardiac death, and 0.8% target-vessel myocardial infarction. One definite scaffold thrombosis occurred on post-procedure day 10 after cessation of dual antiplatelet therapy.
Conclusions: The preliminary analysis of the first 400 patients enrolled in BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in clinical routine.