BIOSOLVE-II: Novel Absorbable Scaffold Safe, Effective
A drug-eluting absorbable metal scaffold offers favorable performance and safety at 6 months, according to results from the first-in-human BIOSOLVE-II trial reported at TCT 2015 and simultaneously published online ahead of print in the Lancet.
The prospective, nonrandomized study spanned 13 sites across Brazil, Europe and Singapore. From October 2013 to May 2015, researchers enrolled 123 patients (mean age 65.2 years; 63.4% men) with de novo coronary artery stenosis who were implanted with the DREAMS 2G device (Biotronik AG).
“DREAMS 2G in BIOSOLVE-II demonstrates significantly improved in-segment late lumen loss compared to its precursor devices tested in the PROGRESS and the BIOSOLVE-I studies,” Michael Haude, MD, PhD, of Lukaskrankenhaus Neuss, Germany, said during his presentation. At 6-month follow-up, the primary endpoint of mean in-segment late lumen loss (LLL) showed a reduction compared with what had been seen in the earlier studies (Figure).
Vasomotion of the scaffolded vessel segment was documented in 80% of patients at 6 months.
IVUS results in a subgroup of 30 patients demonstrated preservation of the scaffold area with a low neointimal area at 6 months, Haude reported. No intraluminal mass was detected on optical coherence tomography.
There were no cases of definite or probable scaffold thrombosis reported in BIOSOLVE-II. Rates of target lesion failure (cardiac death, target-vessel MI, clinically driven TLR, or CABG; 3.3%) and target lesion revascularization (1.7%) were “low [and] comparable to other absorbable scaffolds and permanent drug-eluting stents,” Haude said. There was one case each of target vessel periprocedural MI (0.8%) and cardiac death (0.8%), and two patients (1.7%) had clinically driven TLR.
For patients with de novo coronary artery lesions, the DREAMS 2G scaffold is a feasible option, Haude concluded.
Previous metallic DES remain permanently after implantation, and they have been linked to late and very late stent thrombosis. The DREAMS 2G absorbable metal scaffold is made of a refined magnesium alloy backbone. Unlike the poly(lactide-co-glycolide) polymer matrix/paclitaxel coating of the first-generation DREAMS 1G scaffold, the latest version contains a polylactic acid polymer coating with sirolimus. Additionally, the absorption period of the device is 12 months, compared with 3 to 4 months for DREAMS 1G.
During the discussion following Haude’s presentation, Paul M. Grossman, MD, of VA Ann Arbor, Mich., questioned whether “showing comparisons of LLL across trials is appropriate.” Moderator Davide Capodanno, MD, PhD, of Ferrarotto Hospital, Catania, Italy, agreed but added that, “in the absence of a control group, at least it puts the data in the perspective of the device evolution.”
- Haude reports receiving grant support/research and consultant/honoraria fees from Abbott Vascular, Biotronik, Cardiac Dimensions, Eli Lilly and Company, Medtronic and Volcano Corporation.
- The study was funded by Biotronik AG.