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)

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

Background The 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. Methods Magmaris 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. Results The 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 ±â€¯10.8 and 62.7 ±â€¯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. Conclusion At 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.

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.

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...