DREAMS 2G Research Articles

Sustained Safety and Performance of a Second-Generation Sirolimus-Eluting Absorbable Metal Scaffold: Long-Term Data of the BIOSOLVE-II First-in-Man Trial at 5 Years

BackgroundPermanent drug-eluting stents are associated with a steady increase in late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years. MethodsBIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints of target lesion failure and rate of definite or probable stent thrombosis. ResultsA total of 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischaemia. Target lesion failure rate was 8.0% [95% confidence interval:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarctions, and 6 clinically driven target lesion revascularizations (TLRs). Only one target lesion failure occurred beyond 3 years: a target-vessel myocardial infarction with clinically driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed. ConclusionThe Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II–III and BIOFLOW II trials

BackgroundThe aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. MethodsMagmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. ResultsThe study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. ConclusionAt 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

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] mm2 vs 12 months; 0.78 [0.41 to 1.68] mm2, 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 area. 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.

Preclinical evaluation of degradation kinetics and elemental mapping of first- and second-generation bioresorbable magnesium scaffolds.

Because vascular restoration therapy using bioresorbable vascular scaffolds (BRS) remains an appealing concept to restore vasoreactivity, an understanding of biodegradation remains paramount during preclinical testing. We therefore aimed to investigate the qualitative and temporal course of degradation of magnesium alloy-based bioresorbable vascular scaffolds in juvenile swine. Qualitative characterisation of biodegradation was performed in 41 DREAMS 1G up to three years, while degradation kinetics were acquired in 54 DREAMS 2G implanted into porcine coronary arteries for 28, 90 and 180 days, one and two years. Assessment of end product composition was achieved in DREAMS 2G at 180 days. Myocardium was examined, while an OCT attenuation score was derived at strut level from 180 days to two years in DREAMS 2G. Degradation of DREAMS entails two corrosive phases. At one year, 94.8% of the magnesium was bioabsorbed in DREAMS 2G and, at two years, magnesium was completely replaced by amorphous calcium phosphate. Von Kossa staining revealed variable peri-strut mineralisation at all time points and only small focal myocardial emboli observed in one animal in the 180 days cohort. Strut discontinuity density was low at 28 days (0.5±0.57 per mm) and increased to a density above 7.5 per mm up to one year. OCT attenuation score correlated well with strut-based degradation analysis up to two years. While the current set of data supports vascular safety, clinical trials are warranted to prove the concept of vascular restoration following DREAMS implantation.

TCT-169 Serial 3-dimensional optical coherence tomography assessment of jailed side-branch by second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in BIOSOLVE-II trial

Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is being used for treating coronary lesions. However, the fate of struts jailing small side-branches (SB) after DREAMS 2G implantation remains to be elucidated. Therefore, we investigated the impact of scaffolds on jailed SBs as

CRT-600.07 Comparison of Clinical Outcomes Between Magmaris (dreams 2g) and Orsiro Drug Eluting Stents: Pooled Patient Level Analysis From Biosolve II-III and Bioflow II Trials

Magmaris (DREAMS 2G - Biotronik AG, Bulach, Switzerland), a second generation drug-eluting absorbable metal scaffold, has proved to be safe and effective in the BIOSOLVE-II study up to 2 years follow-up. Recently, biodegradable polymer sirolimus-eluting stent, Orsiro (Biotronik AG, Bulach,

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

RationaleBioresorbable 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. ObjectivesWe assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). Methods and resultsThe 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. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. ConclusionFollowing implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months.NCT01960504

TCT-14 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 12-month follow-up- BIOSOLVE-II and BIOSOLVE-III

Assessment of the safety and clinical performance of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) from the combined analysis of BIOSOLVE-II and BIOSOLVE-III studies at 12-month. One hundred eighty four (184) subjects have been enrolled in BIOSOLVE-II and BIOSOLVE-III studies.

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

We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant. 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. The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.

TCT-416 In vivo assessment of endothelial-dependent vasomotion in a coronary segment treated by the Second-Generation Drug-Eluting Absorbable Metal Scaffold (DREAMS 2G): Insights from the BIOSOLVE-II First-In-Man Trial

To analyse the vasomotion of a coronary segment in relationship to its intravascular ultrasound–virtual histology (IVUS–VH) composition. Coronary segments, transiently scaffolded by a fully absorbable sirolimus eluting Mg scaffold (DREAMS 2G), may in the long-term recover a normal vasomotor tone

TCT-30 Safety, Clinical Performance and multi-modality imaging data of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 12-month follow-up-BIOSOLVE-II

Introduction: In order to assess the intermediate performance, safety and the absorption process of the sirolimus eluting absorbable metal scaffold (DREAMS 2G, second generation) 12-month multi-mod...

TCT-421 In Vivo Serial Assessment of Coronary Vessel Geometry Restoration and Resorption Process Following the Implantation of Second-Generation Drug-Eluting Absorbable Metal Scaffold (DREAMS 2G): Insights from the BIOSOLVE-II First-In-Man Trial

The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile and stable performance outcomes up to 12 months. We assessed the baseline, 6-month and 12-month imaging performance of this novel device which may provide a mechanistic explanation for the

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

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 absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. Biotronik AG.