TY - JOUR JO - EuroIntervention TI - 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 AB - <p class="text-1er-paragraph"><span class="abstracts-titres">Aims:</span> 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. <br/><br/><span class="abstracts-titres">Methods and results:</span> 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).</p> AU - Haude Michael AU - Ince Hüseyin AU - Toelg Ralph AU - Lemos Alves Pedro AU - von Birgelen Clemens AU - Christiansen Høj Evald AU - Wijns William AU - Neumann Franz-Josef AU - Eeckhout Eric AU - Garcia-Garcia M. Hector AU - Waksman Ron VL - IS - Y1 - 26/02/2019 Y1 - 2019 DOI - 10.4244/EIJ-D-18-01000 SP - KW - stable angina KW - bioresorbable scaffolds KW - myocardial infarction KW - stent thrombosis PB - Europa Digital & Publishing UR - https://eurointervention.pcronline.com/article/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 SN - 1774-024X ER -