Key result
DREAMS 2G maintains stable angiographic lumen dimensions through 12 months with no scaffold thrombosis.
Why the study?
Metal absorbable scaffolds are an attractive alternative to polymeric scaffolds, and 12-month safety and performance data were needed following promising 6-month outcomes with the second-generation drug-eluting absorbable metal scaffold.
Observational (n=123)
Yes
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These results offer the first confirmation of Magmaris's longer-term safety and efficacy. BIOSOLVE-II demonstrates a promising potential of a magnesium-based approach to treating coronary artery disease as an alternative to polymer-based bioresorbable scaffolds.”
“DREAMS 2G in BIOSOLVE-II demonstrates significantly improved in-segment late lumen loss compared to its precursor devices tested in the PROGRESS and the BIOSOLVE-I studies.”
“The BIOTRONIK Magnesium Scaffold shows advantages over synthetic polymer-based scaffolds as it can be inflated in a single step. It is based on a natural element widely present in the human body, and the magnesium-based properties promote a faster and simpler implantation procedure. Additionally, the magnesium is absorbed within 12 months, faster than polymer-based bioresorbable scaffolds, while vasomotion is observed at 6 months.”
The second-generation drug-eluting absorbable metal scaffold DREAMS 2G demonstrated sustained safety and stable angiographic performance up to 12 months in patients with de novo coronary lesions.
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. CLINICALTRIALSGOV IDENTIFIER: NCT01960504.
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Haude et al. (2016) conducted an observational in de novo coronary lesions (n=123). DREAMS 2G (second-generation drug-eluting absorbable metal scaffold) was evaluated on In-segment late lumen loss change from 6 to 12 months (Δ 0.05 mm, 95% CI -0.01;0.12, p=0.117). The DREAMS 2G absorbable metal scaffold showed stable angiographic parameters between 6 and 12 months, with an in-segment late lumen loss change of 0.05 mm (p=0.117), and no scaffold thrombosis.
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