Positive six-month results from BIOSOLVE-I FIM trial of DRug-Eluting Absorbable Metal Scaffold device

Six-month results from the BIOSOLVE-I first-in-man (FIM) trial, studying the DRug-Eluting Absorbable Metal Scaffold (DREAMS), demonstrate a high safety profile of the novel device. For the first cohort of 22 patients, there was no cardiac death, no target vessel myocardial infarction (MI) and no stent thrombosis, as presented at the European Conference of Paris Course on Revascularization (EuroPCR) by Professor Michael Haude, Lukas Hospital, Neuss, Germany, one of the investigators of the study.

“As we have previously seen with vascular restoration therapy, 12-month results play an important role after proper healing and remodeling of the vessels.”

The BIOSOLVE-I study is a prospective, multicenter, nonrandomized, European, FIM trial evaluating the safety and efficacy of DREAMS. The primary endpoint is target lesion failure (TLF) at 6 months for cohort 1 and at 12 months for cohort 2. Major secondary outcomes are cumulative major adverse coronary event rates at 1 month, 6 months and 12 months, as well as at 2 years and 3 years; in-scaffold and in-segment late luminal loss are measured at 6- and 12-month follow-ups. In addition to the quantitative coronary angiography (QCA) follow-up, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging are performed at 6 months and 12 months. Vasomotion assessment is completed at the same time points.

Between July and December 2010, 47 DREAMS were implanted in 46 patients. The 6-month outcomes reveal two cases of clinically driven revascularization (4.3%) and one target vessel revascularization (2.2%). The in-scaffold late lumen loss angiographic outcome was 0.68 mm.

"These outcomes demonstrate a considerable improvement over the bare version of the absorbable metal scaffold and confirm that the development strategy is taking the right direction," commented Professor Haude.

Professor Haude also highlighted the superior mechanical properties of the DREAMS scaffold compared with absorbable scaffolds made of polymeric materials. "DREAMS' expansion behavior is very similar to a permanent metallic stent," he reported. "Also, its appearance in OCT at baseline procedure and at follow-up looks like a permanent metallic stent."

The drug-eluting absorbable metal scaffold is part of a revolutionary new treatment option for patients with coronary artery disease. In contrast to existing permanent stents, this device, based on an absorbable magnesium backbone, degrades over time and leaves nothing behind but a healed vessel that can resume its natural functionality.

DREAMS is made of a proprietary magnesium alloy coated with a matrix of a degradable polymer and paclitaxel to inhibit neointimal cell proliferation within the first few months after scaffold implantation. DREAMS, a novel treatment concept designed to eliminate the long-term risks associated with a permanent implant, opens a new area of vascular restoration therapy.

"Looking at the results of the first cohort only, the outcomes of DREAMS confirm a very good safety profile of the absorbable scaffold. While we believe that 6-month outcomes indicate a tendency, longer follow-up periods are necessary before we would draw confident conclusions about this novel therapy," stated Alain Aimonetti, Vice President Marketing and Sales with BIOTRONIK. "As we have previously seen with vascular restoration therapy, 12-month results play an important role after proper healing and remodeling of the vessels."