Outcome of apolymer-free drug-coated coronary stent in bifurcation lesions-Pilot registry with serial OCT imaging.

Abstract

Polymer-free and carrier-free drug-coated stents (DCS) represent anovel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions. Overall, 23 consecutive patients with 24 lesions received aBiolimusA9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3-6months of follow-up. Atotal of 23patients with 24bifurcation lesions were included in this study. Nine(33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19patients with 20bifurcation lesions were suitable for OCT analysis. Atotal of 2936 struts were analyzed and 14struts (0.47%) were classified as malapposed. The mean luminal area (mm2) was not different in lesions with ISR vs. lesions with no ISR (5.07 ± 2.0 vs. 5.73 ± 1.34, p = 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11 ± 10.59 vs. 13.93 ± 9.16%, respectively; p = 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention. We observed ahigh rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings.