Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: 3-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial
EuroIntervention 2019; just accepted article published in February 2019. DOI: 10.4244/EIJ-D-18-01000
Michael Haude1; Hüseyin Ince2; Ralph Toelg3; Pedro Alves Lemos4; Clemens von Birgelen5; Evald Høj Christiansen6; William Wijns7; Franz-Josef Neumann8; Eric Eeckhout9; Hector M. Garcia-Garcia10; Ron Waksman11;
1. Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany, GERMANY; 2. Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany; 3. Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany; 4. Instituto do Coração – HCFMUSP, University of Sao Paulo, São Paulo; 5. Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands; 6. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; 7. Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium; 8. Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg- Bad Krozingen, Bad Krozingen, Germany; 9. Department of Cardiology, Lausanne University Hospital, Switzerland; 10. Interventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA); 11. Interventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA)
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Aims: We evaluated the safety and performance of a magnesium-based sirolimus-eluting metal scaffold at 3-year follow-up to assess vessel response 2 years beyond scaffold resorption.
Methods and results: BIOSOLVE-II is an international, multi-center first-in man study, including 123 patients with de novo lesions. Pre-dilatation was mandatory and post-dilatation was left to the discretion of the investigators. Dual antiplatelet therapy was recommended for 6 months. At 3 years, 91.1% of patients were angina-free and 8.0% were on dual antiplatelet therapy. Target lesion failure rate was 6.8% (n=8; 2 cardiac deaths, 1 target-vessel myocardial infarction and 5 target lesion revascularizations). No probable or definite scaffold thrombosis was observed. Imaging follow-up was voluntary and serial angiographic assessment at 6, 12, and 36 months was available in 25 patients. In these, a slight increase in in-segment and in-scaffold late lumen loss and diameter stenosis was observed between 12 and 36 months (by 0.11±0.28mm and 0.13±0.30mm for late lumen loss, and by 3.8±10.1% and 4.1±10.2% for diameter stenosis).
