First-in-Man BIOSOLVE-II Evaluates Biotronik's Next-Generation Bioresorbable Stent

October 12, 2015—Results from BIOSOLVE-II, a first-in-man study examining 6-month angiographic and clinical outcomes of Biotronik AG’s newest iteration of a bioresorbable stent, were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation, being held October 11–15, in San Francisco, California. The study was funded by a research grant from Biotronik. 

Made from magnesium alloy, the new device demonstrated significant improvement compared to its precursor devices studied in the PROGRESS and BIOSOLVE-I studies.

The study was published simultaneously by Prof. Michael Haude, MD, et al online ahead of print in The Lancet. Prof. Haude, who is coprincipal investigator of the BIOSOLVE-II, commented in the TCT announcement, “The unique design of the magnesium alloy stent provides the strength of metal with the long-term benefit of being absorbed into the body over time. The results from BIOSOLVE-II demonstrate significantly improved in-segment late lumen loss (LLL) at 6-months for this new stent technology compared to its precursor devices.” Prof. Haude is from Lukaskrankenhaus Neuss in Neuss, Germany.

BIOSOLVE-II is a prospective, international, multicenter, first-in-man study examining the safety and efficacy of a Biotronik’s magnesium stent that is coated with poly(l-lactide) and eluting sirolimus. The study enrolled 123 patients with de novo coronary artery stenosis with a primary endpoint of in-segment LLL at 6 months. 

At 6-month follow-up (n = 112), in-segment LLL was 0.27 ± 0.37mm [95% confidence interval [CI], 0.2–0.33]; the target lesion failure rate (composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and coronary artery bypass graft surgery) was 3.3% (95% CI, 1.3–8.3). Additionally, vasomotion of the scaffolded vessel segment was demonstrated at 6 months. And there were low rates of target lesion failure (3.3%) and target lesion revascularization (1.7%).

The new stent used in BIOSOLVE-II demonstrated significantly improved in-segment LLL (0.27 ± 0.37 mm) compared to its precursor devices tested in the BIOSOLVE-I (0.52 ± 0.48 mm; P = .001) and PROGRESS (0.83 ± 0.51 mm; P < .0001) studies. In addition, a subgroup of 30 patients who underwent intravascular ultrasound analysis revealed that compared to BIOSOLVE-I, the neointimal hyperplasia area was reduced by 73% from 0.30 ± 0.41 mm² to 0.08 ± 0.09 mm².