Clinical outcomes in patients treated with the fully absorbable, everolimus-eluting renuviatm scaffold: Primary endpoint results from the fast first human use study.

Abstract

BACKGROUND Permanent stenting with bare metal or drug-eluting stents in the coronary artery is associated with neoatherosclerosis and late thrombotic events. Completely bioabsorbable drug-eluting scaffolds may potentially reduce the risk of late adverse events. RENUVIATM, a balloon expandable scaffold, is made of bioabsorbable poly(L-lactide) and everolimus-eluting abluminal poly(D, L-lactideco- glycolide) polymers. Compared to currently available bioabsorbable scaffolds, RENUVIATM incorporates an optimized design with thinner struts to improve deliverability and overexpansion capabilities, and scaffold fracture resistance. This study evaluates the safety and performance of RENUVIATM in subjects with de novo coronary lesions. Data through 6 months will be reported for the first time at TCT 2017. METHODS Subjects with single de novo native coronary artery lesion (length: <=12mm; reference vessel diameter:>= 2.75mm and <=3.25mm) were enrolled in this prospective, multi-center, single arm feasibility study (N=33). A single scaffold size (3.0mmx16mm) was available for use in the study. The primary endpoints are clinical procedural success (% diameter stenosis <=30% and no in-hospital MACE [death, MI or TLR]) and 6-month angiographic in-scaffold late loss. RESULTS The mean age of patients was 62 years, 67% were male, 24% had medically-treated diabetes, and >60% were treated for hypertension or hyperlipidemia. At the time of writing, 6-month data were available in 22 patients. Clinical procedural success was 90.9% (30/33) due to 3 peri-procedural non-Q-wave MIs. No deaths, TLR, or scaffold thromboses were observed in the analyzed population. At 6 months, angiographic late loss was 0.28+/-0.25 mm in-scaffold and 0.17+/-0.26 mm in-segment; and % diameter stenosis was 19.45+/-11.14% in-scaffold and 26.11+/-9.77 in-segment. The in-scaffold % net volume obstruction was 5.48+/-4.66% (N=17), as measured by IVUS. CONCLUSION Bioabsorbable scaffold technology represents a promising strategy for treatment of coronary artery disease. Complete 6 month data from the FAST study will be available for presentation at TCT and will provide insight into the safety and performance of the second generation RENUVIATM Fully Absorbable Scaffold.