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.
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.
- 2016
Available online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006
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. CLINICALTRIALSGOV IDENTIFIER: NCT01960504. 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. Copyright (c) The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology. 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, DELTA 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, DELTA 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.
English
0195-668X
*Drug-Eluting Stents
Absorbable Implants
Coronary Angiography
Coronary Artery Disease
Humans
Metals
Prospective Studies
Sirolimus
Treatment Outcome
MedStar Heart & Vascular Institute
Journal Article
Available online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006
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. CLINICALTRIALSGOV IDENTIFIER: NCT01960504. 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. Copyright (c) The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology. 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, DELTA 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, DELTA 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.
English
0195-668X
*Drug-Eluting Stents
Absorbable Implants
Coronary Angiography
Coronary Artery Disease
Humans
Metals
Prospective Studies
Sirolimus
Treatment Outcome
MedStar Heart & Vascular Institute
Journal Article