BIOSOLVE II: Evaluation of a Sirolimus-Eluting Absorbable Metallic Scaffold
The DREAMS second-generation (2G) sirolimus-eluting absorbable metal scaffold showed improved performance measures compared to the first-generation version, according to the results of the BIOSOLVE II trial, presented at TCT 2015 and simultaneously published in Lancet.
Michael Haude, MD, et al., assessed the safety and performance of the DREAMS 2G scaffold in a prospective, multicenter, non-randomized, first-in-man trial of 123 patients with de novo coronary artery lesions. The primary endpoint of the trial was in-segment late lumen loss at six months, during which time angiographic follow-up also occurred. Secondary endpoints included rate of target lesion failure – a composite of cardiac death, target vessel myocardial infarction, coronary artery bypass graft surgery and clinically driven target lesion revascularization.
The results of the trial demonstrate the safety of the DREAM 2G scaffold over the first generation DREAM scaffold, including improvements in late lumen loss. At six-month follow-up, the average in-segment late lumen loss was 0.27mm, while the average in-scaffold late lumen loss was 0.44mm.
“DREAMS 2G could be an acceptable alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease,” according to Haude, et al.
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