Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

Michael Haude, Hüseyin Ince, Alexandre Abizaid, Ralph Toelg, Pedro Alves Lemos, Clemens Von Birgelen, Evald Høj Christiansen, William Wijns, Franz Josef Neumann, Christoph Kaiser, Eric Eeckhout, Soo Teik Lim, Javier Escaned, Yoshinobu Onuma, Hector M. Garcia-Garcia, Ron Waksman

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178 Citations (Scopus)

Abstract

Aims Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. Methods and results The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and - if subjects consented - at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis. Conclusion The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months. ClinicalTrials.gov identifier NCT01960504.

Original languageEnglish
Pages (from-to)2701-2709
Number of pages9
JournalEuropean Heart Journal
Volume37
Issue number35
DOIs
Publication statusPublished - 14 Sep 2016
Externally publishedYes

Keywords

  • Bioresorbable
  • Coronary artery disease
  • DREAMS
  • Magnesium
  • PLLA
  • Scaffold

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