In order to assess the intermediate term safety, clinical performance and the bioabsorption process of the Paclitaxel-Eluting Bioabsorbable Magnesium Scaffold (DREAMS) 2-year clinical data of cohort 1 and multi-modality imaging outcomes up to 1 year follow-up are reported.

Forty-six subjects were enrolled in the first-in-man BIOSOLVE-I study, and assigned to two different cohorts with different invasive follow-up schedules. Clinical follow-up for both cohorts is scheduled at 1, 6, 12, 24 and 36 months, angiographic and IVUS follow-up for cohort 1 at 6 months and for cohort 2 at 12 months. A subgroup of patients underwent OCT and vasomotion testing. The primary endpoint is Target Lesion Failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion failure, at 6 months for cohort 1 and at 12 month for cohort 2.

Clinical: TLF rate at 12-month was 7.0% including two clinically driven target lesion revascularizations and one peri-procedural target vessel myocardial infarction occurring during 12-month follow-up angiography. No cardiac death or scaffold thrombosis was observed. Twenty-four month clinical data of cohort 1 will be available upon presentation. Angiographic: In-scaffold late lumen loss was 0.52±0.39 at 12 months. Vasoconstriction after acetylcholine was documented by quantitative coronary angiography (delta=-10.04%; p=0.0008) followed by vasodilatation after nitroglycerine (delta=8.69%; p<0.0001) which demonstrates the uncaging aspect of the absorption process already at 6-month follow-up with no further change at the 12-month follow-up. IVUS: Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 39.5% (p=0.0015) which remains stable until 12-month follow-up. This decrease of dense calcium is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material.

DREAMS shows excellent safety and efficacy data up to 2 years in cohort 1 of the BIOSOLVE-I trial. Multi-modality imaging documented the absorption process and the uncaging aspect of this device already at 6 months.