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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.


Cumulative frequency curves for in-segment (A) and in-scaffold (B) late lumen loss. Six- and twelve-month serial analysis of late lumen loss observed in BIOSOLVE-II compared with BIOSOLVE-I using the precursor device DREAMS first generation.
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ehw196F2: Cumulative frequency curves for in-segment (A) and in-scaffold (B) late lumen loss. Six- and twelve-month serial analysis of late lumen loss observed in BIOSOLVE-II compared with BIOSOLVE-I using the precursor device DREAMS first generation.

Mentions: Paired QCA data could be obtained in 42 patients from seven centres at a mean follow-up time of 181 ± 17 days and 367 ± 17 days for 6- and 12-month assessments, respectively. Paired in-segment LLL at 6 and 12 months was 0.20 ± 0.21 mm (95% CI: 0.13;0.26) and 0.25 ± 0.22 mm (95% CI: 0.18;0.32), P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: −0.01;0.12), and in-scaffold LLL 0.37 ± 0.25 mm (95% CI: 0.29;0.45) and 0.39 ± 0.27 mm (95% CI: 0.31;0.48), P = 0.446, Δ 0.03 ± 0.22 mm (95% CI: −0.04;0.10) (Table 2, Figure 2). The in-segment and in-scaffold LLL of the overall population at 6 months were 0.27 ± 0.37 and 0.44 ± 0.36 mm for the overall population (0.21 ± 0.28 and 0.37 ± 0.28 mm in patients without TLR). There was no statistically significant difference in baseline characteristics between this subgroup and the overall patient population.Table 2


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
Cumulative frequency curves for in-segment (A) and in-scaffold (B) late lumen loss. Six- and twelve-month serial analysis of late lumen loss observed in BIOSOLVE-II compared with BIOSOLVE-I using the precursor device DREAMS first generation.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

ehw196F2: Cumulative frequency curves for in-segment (A) and in-scaffold (B) late lumen loss. Six- and twelve-month serial analysis of late lumen loss observed in BIOSOLVE-II compared with BIOSOLVE-I using the precursor device DREAMS first generation.
Mentions: Paired QCA data could be obtained in 42 patients from seven centres at a mean follow-up time of 181 ± 17 days and 367 ± 17 days for 6- and 12-month assessments, respectively. Paired in-segment LLL at 6 and 12 months was 0.20 ± 0.21 mm (95% CI: 0.13;0.26) and 0.25 ± 0.22 mm (95% CI: 0.18;0.32), P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: −0.01;0.12), and in-scaffold LLL 0.37 ± 0.25 mm (95% CI: 0.29;0.45) and 0.39 ± 0.27 mm (95% CI: 0.31;0.48), P = 0.446, Δ 0.03 ± 0.22 mm (95% CI: −0.04;0.10) (Table 2, Figure 2). The in-segment and in-scaffold LLL of the overall population at 6 months were 0.27 ± 0.37 and 0.44 ± 0.36 mm for the overall population (0.21 ± 0.28 and 0.37 ± 0.28 mm in patients without TLR). There was no statistically significant difference in baseline characteristics between this subgroup and the overall patient population.Table 2

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.