BIOSOLVE-II: Novel magnesium alloy scaffold shows promise in treating CAD
SAN FRANCISCO — A second-generation drug-eluting bioresorbable scaffold made of magnesium alloy appears to be a feasible treatment in patients with de novo coronary artery lesions, with promising safety and performance outcomes observed at 6 months, according to study results presented at the annual TCT Scientific Symposium and published online in The Lancet.
In the prospective, international, multicenter, first-in-man BIOSOLVE-II trial, the Dreams 2G device (Biotronik) showed significant improvement over devices studied in the earlier PROGRESS and BIOSOLVE-I studies and could present an alternative approach to absorbable polymeric scaffolds
“It has a refined magnesium alloy, which has two markers at its proximate distal ends and a [poly- L-lactide] layer that eludes sirolimus at the antiproliferative tract,” Michael Haude, MD, PhD, of Lukaskrankenhaus in Neuss, Germany, said in a presentation. “This device has an absorption time of 12 months — being clearly longer than the precursor versions but being significantly shorter than [other poly- L-lactide] versions.”
Haude, with an international team of investigators, enrolled 123 patients with stable or unstable angina, or documented silent ischemia, from 13 PCI centers throughout Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland and the Netherlands. Patients had 123 lesions, with reference vessel diameters between 2.2 mm and 3.7 mm.
The investigators performed clinical follow-up at 1, 6, 12, 24 and 36 months. Angiographic follow-up was scheduled at 6 months, with a subgroup of patients to receive IVUS, OCT and vasomotion assessment.
Dual antiplatelet therapy for at least 6 months was recommended for all patients. The investigators primarily sought in-segment late lumen loss at 6 months and analyzed data based on intention to treat.
The investigators observed a mean in-segment late lumen loss of 0.27 mm (standard deviation [SD], 0.37) at 6 months, with angiographically discernable vasomotion documented in 80% of patients.
IVUS assessments demonstrated a mean scaffold area preservation of 6.24 mm² (SD, 1.15) postprocedure vs. 6.21 mm² (SD, 1.22) at 6 months. Further, a low mean neointimal area (0.08 mm²; SD, 0.09) was observed, and no intraluminal mass was detected through OCT.
Four (3%) patients experienced target lesion failure; one died from cardiac death, one had periprocedural MI, and two required clinically driven target lesion revascularization. The investigators observed no definite or probable stent thrombosis.
“Dreams 2G demonstrates a significantly improved in-segment late-lumen loss compared to its precursors,” Haude said. “Vasomotion was present … [there were] no intraluminal masses in OCT with respect to the clinical results … comparable TLF and TLR rates to permanent drug-eluting stents or other scaffolds, and not a single stent thrombosis case.” – by Allegra Tiver
Haude M, et al. BIOSOLVE II: Evaluation of a Sirolimus-Eluting Bioresorbable Metallic Scaffold – Six-Month Clinical, Angiographic, and Imaging Outcomes. Presented at: TCT 2015; Oct. 11-15, 2015; San Francisco.
Disclosure: Haude reports receiving grant and lecture fees from Abbott Vascular, Biotronik, Cardiac Dimensions, Medtronic, Lilly and Volcano. The study was funded by Biotronik.