Safety and performance of the second-generation
drug-eluting absorbable metal scaff old in patients with
de-novo coronary artery lesions (BIOSOLVE-II): 6 month
results of a prospective, multicentre, non-randomised,
fi rst-in-man trial
Michael Haude, Hüseyin Ince, Alexandre Abizaid, Ralph Toelg, Pedro Alves Lemos, Clemens von Birgelen, Evald Høj Christiansen, William Wijns,
Franz-Josef Neumann, Christoph Kaiser, Eric Eeckhout, Soo Teik Lim, Javier Escaned, Hector M Garcia-Garcia, Ron Waksman
Summary
Background Absorbable scaff olds were designed to overcome the limitations of conventional, non-absorbable
metal-based drug-eluting stents. So far, only polymeric absorbable scaff olds are commercially available. We aimed to
assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaff old (DREAMS 2G)
in patients with de-novo coronary artery lesions.
Methods We did this prospective, multicentre, non-randomised, fi rst-in-man trial at 13 percutaneous coronary
intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands.
Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo
lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled
at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of
patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All
patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was insegment
late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.
gov, number NCT01960504.
Findings Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At
6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion
was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the
scaff old area (mean 6·24 mm² [SD 1·15] post-procedure vs 6·21 mm² [1·22] at 6 months) with a low mean neointimal
area (0·08 mm² [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure
occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural
myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No defi nite or
probable scaff old thrombosis was observed.
Interpretation Our fi ndings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible,
with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaff old could be an
alternative to absorbable polymeric scaff olds for treatment of obstructive coronary disease.