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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.


Change in vasomotion between 6 and 12 months. Percentage change in mean lumen diameter after acetylcholine and after subsequent intracoronary injection of nitroglycerine at 6 and 12 months in 14 patients. Each line reflects one patient. The ends of the boxes represent the first and third quartiles, the band the median, and the crystal the mean. There was no statistical significant difference between 6 and 12 months (P = 0.808 for acetylcholine and P = 0.626 for nitroglycerine). ACH, acetylcholine; Nitro, nitroglycerine.
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ehw196F5: Change in vasomotion between 6 and 12 months. Percentage change in mean lumen diameter after acetylcholine and after subsequent intracoronary injection of nitroglycerine at 6 and 12 months in 14 patients. Each line reflects one patient. The ends of the boxes represent the first and third quartiles, the band the median, and the crystal the mean. There was no statistical significant difference between 6 and 12 months (P = 0.808 for acetylcholine and P = 0.626 for nitroglycerine). ACH, acetylcholine; Nitro, nitroglycerine.

Mentions: Serial vasomotion at 6 and 12 months was tested in 14 patients; thereof 11 (79%) had a change of >3% to the mean lumen diameter after infusion or injection of acetylcholine (Figure 5). The median percentage change in mean lumen diameter between pre-and post-acetylcholine was −2.6% (IQR: −6.4 to −0.6%, mean −5.1 ± 7.7%) at 6 months and −3.4% (IQR: −9.4 to 3.2%, mean −3.4 ± 11.0%) at 12 months; the percentage change in mean lumen diameter between post-acetylcholine and nitroglycerine was 3.4% (IQR: 1.1–9.2%, mean 5.8 ± 6.4%) and 6.7% (IQR: 0.0–17.4%, mean 8.2 ± 10.6%), respectively.Figure 5


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
Change in vasomotion between 6 and 12 months. Percentage change in mean lumen diameter after acetylcholine and after subsequent intracoronary injection of nitroglycerine at 6 and 12 months in 14 patients. Each line reflects one patient. The ends of the boxes represent the first and third quartiles, the band the median, and the crystal the mean. There was no statistical significant difference between 6 and 12 months (P = 0.808 for acetylcholine and P = 0.626 for nitroglycerine). ACH, acetylcholine; Nitro, nitroglycerine.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

ehw196F5: Change in vasomotion between 6 and 12 months. Percentage change in mean lumen diameter after acetylcholine and after subsequent intracoronary injection of nitroglycerine at 6 and 12 months in 14 patients. Each line reflects one patient. The ends of the boxes represent the first and third quartiles, the band the median, and the crystal the mean. There was no statistical significant difference between 6 and 12 months (P = 0.808 for acetylcholine and P = 0.626 for nitroglycerine). ACH, acetylcholine; Nitro, nitroglycerine.
Mentions: Serial vasomotion at 6 and 12 months was tested in 14 patients; thereof 11 (79%) had a change of >3% to the mean lumen diameter after infusion or injection of acetylcholine (Figure 5). The median percentage change in mean lumen diameter between pre-and post-acetylcholine was −2.6% (IQR: −6.4 to −0.6%, mean −5.1 ± 7.7%) at 6 months and −3.4% (IQR: −9.4 to 3.2%, mean −3.4 ± 11.0%) at 12 months; the percentage change in mean lumen diameter between post-acetylcholine and nitroglycerine was 3.4% (IQR: 1.1–9.2%, mean 5.8 ± 6.4%) and 6.7% (IQR: 0.0–17.4%, mean 8.2 ± 10.6%), respectively.Figure 5

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.