Abstract 10029: Six and Twelve-month Clinical and Imaging Results of the Multicenter First-in-man BIOSOLVE-I Study with the Paclitaxel-Eluting Bioabsorbable Magnesium Scaffold (DREAMS)
Background Absorbable metal scaffolds (AMS) are developed to overcome limitations of current permanent bare or drug-eluting coronary stents like stent thrombosis despite prolonged dual antiplatelet therapy, caged vessel segment not allowing vasomotion and remodelling or chronic vessel wall inflammation. Magnesium is an essential element of the human body, thus it is considered as a potential alloy for absorption. To overcome the limitations associated with the first generation of a bare AMS a Drug (Paclitaxel) Eluting Absorbable Magnesium Scaffold was developed (DREAMS).
Methods Forty-six subjects were enrolled in the BIOSOLVE-I study, and assigned to two cohorts with different follow-up schedules. Clinical follow-up for both cohorts was scheduled at 1, 6, 12, 24 and 36 months, angiographic and IVUS follow-up for cohort 1 at 6 and for cohort 2 at 12 months. A subgroup of patients underwent OCT and vasomotion testing. The primary endpoint is Target Lesion Failure (TLF), a composite of cardiac death, target vessel MI and clinically driven target lesion failure, at 6 months for cohort 1 and at 12 month for cohort 2.
Results TLF rate at 6 and 12-month was 4.3% and 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 occurred. In-scaffold lumen loss was 0.65±0.50 mm at 6-months and 0.52±0.39 at 12 months. Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 39.5% (p=0.0015) with no further decrease until 12-month follow-up. This decrease of dense calcium is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material. OCT results demonstrate apposition post-procedure in 95.9%, at 6-month in 97.2% and at 12-month in 99.8% and excellent strut coverage at 6 and 12-month.
Conclusion DREAMS showed an excellent safety profile and a low TLF rate up to 12-month with promising angiographic data. VH data prove completion of the bioabsorption at 6-month. The low incidence of incomplete strut apposition demonstrates that the acute behaviour is comparable to conventional stents.
- © 2012 by American Heart Association, Inc.