Evaluation of the novel novolimus-eluting bioresorbable vascular scaffold for the treatment of de novo coronary artery stenosis: serial optical coherence tomography analysis of the DESolve NX study

Abstract

Purpose: The DESolve system is a novel Poly-L-Lactide (PLLA)-based scaffold, designed to provide both temporary vessel support along with neointimal suppression, followed by full bioresorption between one and two years. In the present study, we aim to present the first serial optical coherence tomography (OCT) evaluation of the novel PLLA-based novolimus-eluting DESolve bioresorbable scaffold investigated in the DESolve NX study. Methods: The DESolve NX study enrolled 126 patients with single de novo native coronary lesions at 13 sites. A serial (baseline and 6-month follow-up) analysis of the first 25-patient subset who underwent OCT examination will be presented. All OCT images were analyzed by an independent core laboratory at 0.6-mm interval. At baseline, lumen, scaffold, plaque prolapse and incomplete scaffold apposition (ISA) areas were determined. At follow-up, serial changes in lumen and scaffold dimensions and degree of neointimal hyperplasia (NIH) formation on top of the struts will be assessed. Frequency of covered struts and NIH thickness on top of each covered strut will also be examined. OCT imaging end-points were scaffold expansion and structural integrity post-procedure and neointimal obstruction and degree of strut coverage at six-month follow-up. Results: At baseline, overall adequate scaffold expansion (93.75±9.21%) was obtained. A mean of 30.44±5.16 cross-sections were analyzed per scaffold. Mean lumen and scaffold areas measured 6.80±1.35 mm2 and 6.95±1.32 mm2, respectively, with a minimum scaffold area post-procedure of 5.71±1.15 mm2. In average, plaque prolapse accounted for a very small area of lumen reduction post-procedure (0.03±0.02 mm2). ISA was detected at baseline in 9 (36%) scaffolds, but it was in average very small (0.07±0.13 mm2). A total of 9,871 struts were analyzed at baseline, and the frequency of malapposed struts per patient was 0.43±0.98%. All 25 patients have already completed 6-month OCT evaluation, and the images are currently under analysis. The complete serial OCT results will be available at the meeting. Conclusions: The novel PLLA-based novolimus-eluting bioresorbable scaffold demonstrated an excellent acute performance, tolerating very good expansion with virtually no structural deformity concerns. Good vessel wall conformability was also demonstrated, resulting in minimal areas of scaffold malapposition. Six-month OCT analysis is being conducted and will be presented at the meeting.