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

Michael Haude*, Hüseyin Ince, Ralph Toelg, Pedro Alves Lemos, Clemens Von Birgelen, Evald Høj Christiansen, William Wijns, Franz Josef Neumann, Eric Eeckhout, Hector M. Garcia-Garcia, Ron Waksman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

8 Citations (Scopus)

Abstract

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 insegment 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.

Original languageEnglish
Pages (from-to)E1375-E1382
JournalEuroIntervention
Volume15
Issue number15
DOIs
Publication statusPublished - Feb 2020
Externally publishedYes

Keywords

  • Bioresorbable scaffolds
  • Myocardial infarction
  • Stable angina
  • Stent thrombosis

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