Safety and Clinical performance of the drug-eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries at 36- month follow-up: BIOSOLVE-II and BIOSOLVE-III

BACKGROUND: Assessment of the safety and clinical performance of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) from the combined analysis of BIOSOLVE- II and -III studies at 36 months. METHODS A total of 184 subjects have been enrolled in the BIOSOLVE-II and -III studies. Clinical follow-ups are scheduled at 1, 6, 12, 24, and 36 months plus 60 months for BIOSOLVE-II. Angiographies are planned at 6 months and voluntarily at 12 and 36 months in BIOSOLVE-II, and 1 angiography is mandatory at 12 months in the BIOSOLVE-III study. Dual antiplatelet therapy is recommended for a minimum of 6 months. The angiographic results are analyzed by an independent core laboratory and all clinical events were adjudicated by an independent clinical events committee. RESULTS A total of 117 men and 67 women with 189 lesions, mean age 65.5 _ 10.8 years, were enrolled at 18 sites in Europe, Brazil, and Singapore. Hypertension was presente in 79.3% of the subjects and 62% had hyperlipidemia. The mean lesion length was 12.6 _ 5.1 mm with a mean reference vessel diameter of 2.70 _ 0.43 mm. At 12 months, 97 patients had available angiographic follow-up. There was no difference in late lumen loss between the 2 studies; in the overall population, it was 0.25 _ 0.31 mm in-segment and 0.39 _ 0.34 mm in-scaffold. The target lesion failure (TLF) rate of the combined population was 3.3%, including 2 cardiac deaths (1.1%), 1 target vessel myocardial infarction (0.6%), and 3 clinically driven target lesion revascularizations (1.7%). The 36-month clinical data of BIOSOLVE- II study are available. Target lesion failure occurred in 8 patients (6.8%) and included 2 cardiac deaths (1.7%), 1 target vessel myocardial infarction (0.9%), and 5 clinically driven target lesion revascularizations (4.3%). No definite or probable scaffold thrombosis was observed. The 36- month clinical visits are ongoing for BIOSOLVE-III patients and data of the combined cohort will be available upon presentation. CONCLUSION The 36-month results of DREAMS 2G, meaning 2 years beyond the completion of resorption, are encouraging on safety and clinical performance standpoints. They will be presented for a larger population of subjects enrolled in the BIOSOLVE-II and -III studies. (AU)

Impact of procedural characteristics on coronary vessel wall healing following implantation of second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary artery lesions: an optical coherence tomography analysis

AIMS : Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold dimensions after implantation of DREAMS 2G and vessel healing and luminal results at follow-up is unknown. The aim of this study is, therefore, to investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall. METHODS AND RESULTS : This study comprises of a total 65 out of 123 patients who were enrolled in the BIOSOLVE-II trial. We assessed both qualitative and quantitative OCT findings and the expansion index of DREAMS 2G after implantation frame by frame using OCT. Expansion index was defined as minimum scaffold area/mean reference lumen area. The over-expansion group was also defined with expansion index >1.0. The total number of analyzed frames at post-procedure and 6-month follow-up was 8243 and 8263 frames, respectively. At 6-month follow-up, in-scaffold healing was documented by the reduction of 82% in dissections, 93% in attached intra-luminal mass (ILM), 65% in non-attached ILM, and 76% in jailed side branch. The over-expansion group had significantly greater in-scaffold luminal volume loss (LVL) compared with the non-over-expansion group [over-expansion: 35.0 (18.5-52.1) mm3 vs. non-over-expansion: 21.0 (11.6-37.9) mm3, P = 0.039]. CONCLUSION : Excellent in vivo healing process after implantation of DREAMS 2G was observed at 6 months. We found that higher expansion indices were associated with higher in-scaffold LVL at 6 months assessed by OCT. (AU)

First report of edge vascular response at 12 months of Magmaris, a second-generation drug-eluting resorbable magnesium scaffold, assessed by grayscale intravascular ultrasound, virtual histology, and optical coherence tomography. A biosolve-II trial sub-study

Introduction and objective: The edge vascular response (EVR) remains unknown in second generation drugeluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. Results: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not showany significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process a the edges of the RMS. Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imagingmodalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over timein the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

Serial 3 dimensional optical coherence tomography assessment of jailed side branch by second-generation drug-eluting absorbable metal scaffold (from the BIOSOLVE-II Trial)

Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is used for treating coronary lesions. However, the natural history of the jailed side-branch (SB) after DREAMS 2G implantation remains to be elucidated. The aim of this study is to investigate the effect of scaffold struts on jailed SBs as assessed by 3-dimensional (3D) optical coherence tomography (OCT) after implantation of DREAMS 2G. We enrolled the patients who received a DREAMS 2G implantation and where OCT was performed at postprocedure and 12-month follow-up in the BIOSOLVE-II trial. The area of the ostium of jailed SBs and number of compartments divided by scaffold struts were assessed by cut-plane analysis using 3D OCT. A total of 24 patients with 61 jailed SBs were analyzed in this study. The number of compartments was significantly decreased (postprocedure; 1.98 +/- 0.84 vs 12 months; 1.10 +/- 0.30, p <0.001) during the 12 months. Since most of the struts disappeared, the ostium area was increased in 62% of jailed SBs at 12 months, however, not significantly different from postprocedure (postprocedure; 0.74 [0.34 to 1.46] mm(2) vs 12 months; 0.78 [0.41 to 1.68] mm(2), p=0.055). The number of compartments created by scaffold struts and branching angle at postprocedure had no effect on the changes of SB ostium área. DREAMS 2G has a favorable absorption process in the jailed SBs up to 12 months and may be considered as an optional therapy for treating lesions that involve SBs. (AU)

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III

OBJECTIVES: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data. BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III). RESULTS: Mean patient age was 65.5 6 10.8 years and mean lesion reference diameter was 2.70 6 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P 5 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 6 0.31 mm in-segment and 0.396 0.34 mm in scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. CONCLUSION: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.

In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris — DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial

RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months...

Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III

AIMS: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant. METHODS AND RESULTS: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis...

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

Aims: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomesof a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesiumscaffold 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 novolesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at6 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 42patients: in-segment late lumen loss 0.20 + 0.21 mm vs. 0.25 + 0.22 mm, P » 0.117, D 0.05 + 0.21 mm (95%CI: 20.01;0.12); in-scaffold late lumen loss 0.37 + 0.25 mm vs. 0.39 +0.27 mm, P » 0.446, D 0.03 + 0.22 (95%CI: 20.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroboratedthe 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 eventoccurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienceda definite or probable scaffold thrombosis...

Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial

Background Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorb...