The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Coronary interventions

Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

EuroIntervention 2020;15:e1375-e1382. DOI: 10.4244/EIJ-D-18-01000

1. Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, 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, Brazil; 5. Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands; 6. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; 7. Department of Cardiology, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium

Aims: We aimed to evaluate the safety and performance of a magnesium-based sirolimus-eluting metal scaffold at three-year follow-up to assess vessel response two years beyond scaffold resorption.

Methods and results: BIOSOLVE-II is an international, multicentre first-in-man study, including 123 patients with de novo lesions. Predilatation was mandatory and post-dilatation was left to the discretion of the investigators. Dual antiplatelet therapy was recommended for six months. At three years, 91.1% of patients were angina-free and 8.0% were on dual antiplatelet therapy. The target lesion failure rate was 6.8% (n=8: two cardiac deaths, one target vessel myocardial infarction and five target lesion revascularisations). 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±0.28 mm and 0.13±0.30 mm for late lumen loss, and by 3.8±10.1% and 4.1±10.2% for diameter stenosis).

Conclusions: Two years beyond the resorption period of a sirolimus-eluting bioresorbable metal scaffold built from a proprietary magnesium alloy, complication rates remained low. In the patients with serial angiographic assessment, late lumen loss and diameter stenosis did not increase substantially beyond the resorption period.

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