Absorbable Metal Scaffold in Patients With De Novo Coronary Lesions
What is the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary artery lesions?
The BIOSOLVE-II investigators conducted a prospective, multicenter, nonrandomized, first-in-man trial at 13 percutaneous coronary intervention centers in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischemia, 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 in-segment late lumen loss at 6 months. Analysis was by intention to treat.
Between October 8, 2013, and May 22, 2015, 123 patients with 123 coronary target lesions were enrolled. At 6 months, mean in-segment late lumen loss was 0.27 mm (standard deviation 0.37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold 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 revascularization. No definite or probable scaffold thrombosis was observed.
The authors concluded that implantation of the DREAMS 2G device in de novo coronary lesions is feasible, with favorable safety and performance outcomes at 6 months.
This study reports that the DREAMS 2G absorbable metal scaffold showed improved performance measures, with a favorable safety profile up to 6 months, compared with its precursor, DREAMS 1G. No definite or probable scaffold thrombosis was observed for DREAMS 2G or any of the precursor devices, and the rates of target lesion failure and revascularization in this study were low. Vasomotion was restored at 6 months. The metal in DREAMS 2G may provide stronger scaffold than polymeric absorbable stents and it is possible that DREAMS 2G may be a reasonable alternative to absorbable polymeric scaffolds in the future. Head-to-head comparative trials between polymeric bioabsorbable, metallic absorbable, and third-generation permanent metallic drug-eluting stents with hard long-term clinical endpoints are indicated to define the optimal stent platform for patients with coronary artery disease.
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