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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.


Serial angiographic, optical coherence tomography, intravascular ultrasound, and virtual histology of a patient implanted with DREAMS 2G. Matched images show that at 6 months, struts are hardly discernible by optical coherence tomography and the scaffold strut that had covered the side branch post-procedure (12 o'clock) had disappeared. At 12 months, the vessel surface appears even smoother than at 6 months (2 o'clock). On intravascular ultrasound, strut remnants are still discernible at follow-up. Assessed by virtual histology, the white colour coding of the scaffold struts disappears over time demonstrating the absorption process. A–A′, scaffolded segment; P, proximal reference; D, distal reference.
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ehw196F4: Serial angiographic, optical coherence tomography, intravascular ultrasound, and virtual histology of a patient implanted with DREAMS 2G. Matched images show that at 6 months, struts are hardly discernible by optical coherence tomography and the scaffold strut that had covered the side branch post-procedure (12 o'clock) had disappeared. At 12 months, the vessel surface appears even smoother than at 6 months (2 o'clock). On intravascular ultrasound, strut remnants are still discernible at follow-up. Assessed by virtual histology, the white colour coding of the scaffold struts disappears over time demonstrating the absorption process. A–A′, scaffolded segment; P, proximal reference; D, distal reference.

Mentions: Serial IVUS and OCT analyses at 6 and 12 months were performed in 11 patients (respective data listings are provided in the Supplementary material online, Tables S2 and S3). Paired IVUS parameters did not differ significantly between 6 and 12 months (median minimum lumen area of 4.80 vs. 4.69 mm2, P = 0.700), except for the number of patients with incomplete strut apposition, which was reduced to zero at 12 months (Supplementary material online, Table S4; Figure 3). By OCT, the median minimal lumen area decreased from 4.58 mm2 at 6 months to 4.19 mm2 at 12 months, P = 0.032. No intraluminal mass was observed at any time. Figure 4 shows that at 6 and 12 months, strut-like remnants are only visible by IVUS but not by OCT.Figure 3


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
Serial angiographic, optical coherence tomography, intravascular ultrasound, and virtual histology of a patient implanted with DREAMS 2G. Matched images show that at 6 months, struts are hardly discernible by optical coherence tomography and the scaffold strut that had covered the side branch post-procedure (12 o'clock) had disappeared. At 12 months, the vessel surface appears even smoother than at 6 months (2 o'clock). On intravascular ultrasound, strut remnants are still discernible at follow-up. Assessed by virtual histology, the white colour coding of the scaffold struts disappears over time demonstrating the absorption process. A–A′, scaffolded segment; P, proximal reference; D, distal reference.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

ehw196F4: Serial angiographic, optical coherence tomography, intravascular ultrasound, and virtual histology of a patient implanted with DREAMS 2G. Matched images show that at 6 months, struts are hardly discernible by optical coherence tomography and the scaffold strut that had covered the side branch post-procedure (12 o'clock) had disappeared. At 12 months, the vessel surface appears even smoother than at 6 months (2 o'clock). On intravascular ultrasound, strut remnants are still discernible at follow-up. Assessed by virtual histology, the white colour coding of the scaffold struts disappears over time demonstrating the absorption process. A–A′, scaffolded segment; P, proximal reference; D, distal reference.
Mentions: Serial IVUS and OCT analyses at 6 and 12 months were performed in 11 patients (respective data listings are provided in the Supplementary material online, Tables S2 and S3). Paired IVUS parameters did not differ significantly between 6 and 12 months (median minimum lumen area of 4.80 vs. 4.69 mm2, P = 0.700), except for the number of patients with incomplete strut apposition, which was reduced to zero at 12 months (Supplementary material online, Table S4; Figure 3). By OCT, the median minimal lumen area decreased from 4.58 mm2 at 6 months to 4.19 mm2 at 12 months, P = 0.032. No intraluminal mass was observed at any time. Figure 4 shows that at 6 and 12 months, strut-like remnants are only visible by IVUS but not by OCT.Figure 3

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.