The DREAMS 2G drug-eluting absorbable metal scaffold showed sustained safety at 12 months with a 3.4% target lesion failure rate and stable in-segment late lumen loss between 6 and 12 months.
Does the DREAMS 2G drug-eluting absorbable metal scaffold demonstrate safety and stable angiographic performance at 12 months in patients with de novo coronary lesions?
The DREAMS 2G absorbable magnesium scaffold demonstrated a favorable safety profile with no scaffold thrombosis and stable angiographic parameters 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.
“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.”
Haude et al. (2016) studied de novo coronary lesions (n=123). Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) was evaluated on Target lesion failure. The DREAMS 2G drug-eluting absorbable metal scaffold showed sustained safety at 12 months with a 3.4% target lesion failure rate and stable in-segment late lumen loss between 6 and 12 months.