Limits...
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

View Article: PubMed Central - PubMed

ABSTRACT

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.

No MeSH data available.


Patient flow chart. IVUS, intravascular ultrasound; OCT, optical coherence tomography. aTwo patients who did not receive an implant were used for calculation of device and procedural success only. bThirty-four visits were conducted by phone. cForty-five angiographic assessments of which two were excluded as they did not have matched projections recorded, one did not have a 6-month but only 12-month angiography.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC5037291&req=5

ehw196F1: Patient flow chart. IVUS, intravascular ultrasound; OCT, optical coherence tomography. aTwo patients who did not receive an implant were used for calculation of device and procedural success only. bThirty-four visits were conducted by phone. cForty-five angiographic assessments of which two were excluded as they did not have matched projections recorded, one did not have a 6-month but only 12-month angiography.

Mentions: Between October 2013 and May 2015, 123 subjects were enrolled. Clinical follow-up at 12 months was 98% (Figure 1). Baseline parameters are listed in Table 1. A comparison of baseline parameters of the angiographic and IVUS/OCT subgroups with serial 6- and 12-month evaluation compared with the overall population is provided in the Supplementary material online, Table S1. In two lesions, DREAMS 2G could not be implanted due to insufficient pre-dilatation; follow-up of these two subjects was consequently not included in this analysis.Table 1


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
Patient flow chart. IVUS, intravascular ultrasound; OCT, optical coherence tomography. aTwo patients who did not receive an implant were used for calculation of device and procedural success only. bThirty-four visits were conducted by phone. cForty-five angiographic assessments of which two were excluded as they did not have matched projections recorded, one did not have a 6-month but only 12-month angiography.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5037291&req=5

ehw196F1: Patient flow chart. IVUS, intravascular ultrasound; OCT, optical coherence tomography. aTwo patients who did not receive an implant were used for calculation of device and procedural success only. bThirty-four visits were conducted by phone. cForty-five angiographic assessments of which two were excluded as they did not have matched projections recorded, one did not have a 6-month but only 12-month angiography.
Mentions: Between October 2013 and May 2015, 123 subjects were enrolled. Clinical follow-up at 12 months was 98% (Figure 1). Baseline parameters are listed in Table 1. A comparison of baseline parameters of the angiographic and IVUS/OCT subgroups with serial 6- and 12-month evaluation compared with the overall population is provided in the Supplementary material online, Table S1. In two lesions, DREAMS 2G could not be implanted due to insufficient pre-dilatation; follow-up of these two subjects was consequently not included in this analysis.Table 1

View Article: PubMed Central - PubMed

ABSTRACT

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.

No MeSH data available.