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.

Détails

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Etat: Public
Version: de l'auteur
ID Serval
serval:BIB_21015713313F
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
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.
Périodique
European heart journal
Auteur(s)
Haude M., Ince H., Abizaid A., Toelg R., Lemos P.A., von Birgelen C., Christiansen E.H., Wijns W., Neumann F.J., Kaiser C., Eeckhout E., Lim S.T., Escaned J., Onuma Y., Garcia-Garcia H.M., Waksman R.
ISSN
1522-9645 (Electronic)
ISSN-L
0195-668X
Statut éditorial
Publié
Date de publication
14/09/2016
Peer-reviewed
Oui
Volume
37
Numéro
35
Pages
2701-2709
Langue
anglais
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study
Publication Status: ppublish
Résumé
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.
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.
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.
NCT01960504.

Mots-clé
Absorbable Implants, Coronary Angiography, Coronary Artery Disease, Drug-Eluting Stents, Humans, Metals, Prospective Studies, Sirolimus, Treatment Outcome, Bioresorbable, Coronary artery disease, DREAMS, Magnesium, PLLA, Scaffold
Pubmed
Web of science
Open Access
Oui
Création de la notice
31/05/2016 17:39
Dernière modification de la notice
20/08/2019 13:57
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