TY - JOUR
T1 - Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions
T2 - 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial
AU - Haude, Michael
AU - Ince, Hüseyin
AU - Abizaid, Alexandre
AU - Toelg, Ralph
AU - Lemos, Pedro Alves
AU - Von Birgelen, Clemens
AU - Christiansen, Evald Høj
AU - Wijns, William
AU - Neumann, Franz Josef
AU - Kaiser, Christoph
AU - Eeckhout, Eric
AU - Lim, Soo Teik
AU - Escaned, Javier
AU - Onuma, Yoshinobu
AU - Garcia-Garcia, Hector M.
AU - Waksman, Ron
N1 - Publisher Copyright:
© 2016 The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2016/9/14
Y1 - 2016/9/14
N2 - 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.
AB - 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.
KW - Bioresorbable
KW - Coronary artery disease
KW - DREAMS
KW - Magnesium
KW - PLLA
KW - Scaffold
UR - http://www.scopus.com/inward/record.url?scp=84990876384&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehw196
DO - 10.1093/eurheartj/ehw196
M3 - Article
C2 - 27190094
AN - SCOPUS:84990876384
SN - 0195-668X
VL - 37
SP - 2701
EP - 2709
JO - European Heart Journal
JF - European Heart Journal
IS - 35
ER -