Abstract 11264: Three-Year Clinical Data of the Biosolve-I Study With the Paclitaxel-Eluting Bioabsorbable Magnesium Scaffold (Dreams) and Multi-Modality Imaging Analysis
Background: In order to assess the intermediate term safety, clinical performance and the bioabsorption process of the Paclitaxel-Eluting Bioabsorbable Magnesium Scaffold (DREAMS) 3-year clinical data of cohort 1 and multi-modality imaging outcomes are reported.
METHODS: Forty-six subjects were enrolled in the first-in-man BIOSOLVE-I study in two different cohorts with clinical follow-up at 1, 6, 12, 24 and 36 months; angiographic and IVUS follow-up for cohort 1 at 6-month and for cohort 2 at 12-month. A subgroup of patients underwent OCT and vasomotion testing. The primary endpoint is Target Lesion Failure (TLF) at 6-month for cohort 1 and at 12-month for cohort 2. For some patients also 18-month and 24-month imaging data are available.
RESULTS: TLF rate at 24-month was 6.8% including 2 TLRs and 1 peri-procedural MI occurring at the 12-month follow-up angiography; no events emerged from 12- to 24-month. No cardiac death or scaffold thrombosis was observed. 36-month clinical data of Cohort 1 will be available upon presentation.
Vasoconstriction after acetylcholine at 6-month (Δ=-10.04%; p=0.0008 versus baseline) followed by vasodilatation after nitroglycerine (Δ=8.69%; p<0.0001 versus baseline) demonstrates the uncaging aspect of the absorption process with no further change at the 12-month follow-up.
Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 39.5% (p=0.0015) remaining stable from 6- to 12-month follow-up. This decrease is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material. Preliminary echogenicity data using the decrease in intensity of the ultrasound signal to quantify the change in strut structure demonstrate a relatively large decrease of hyperechogenicity (28.5%) in the first 6-month, followed by lower decrease (18.4%) in the 6 months thereafter, with indications that the hyperechogenicity at 18-month returns to the values seen pre-implantation.
Conclusion: DREAMS shows excellent safety and efficacy data with no death and no scaffold thrombosis up to 3 years in the BIOSOLVE-I trial. Multi-modality imaging documented the absorption process and the uncaging aspect of this device already at 6 months.
- © 2013 by American Heart Association, Inc.