Coronary Intervent Ions

Aims: Newly developed drug-eluting stents (DES) aim to promote early endothelialisation and prevent stent thrombosis. We sought to evaluate the extent of neointima growth by optical coherence tomography (OCT) three months after implantation of a polymer-free stent with a nano-sized-pore surface eluting sirolimus. Methods and results: In this prospective, multicentre, open-label study, patients were enrolled with documented stable angina or silent ischaemia and planned intervention for up to two de novo coronary lesions (in different vessels), with lesion length of ≤18 mm. The primary OCT endpoint was the percentage of in-stent neointimal volume obstruction at three months. The secondary endpoints included binary restenosis, stent thrombosis and device-oriented composite endpoints: a composite of cardiac death, myocardial infarction (MI) non-attributable to non-target vessel and clinically indicated target lesion revascularisation at three months. A total of 45 patients with 47 lesions were enrolled from four European sites. Eventually, 43 patients with 45 lesions underwent OCT examination at three months (one case was excluded for poor image quality and one case due to catheter dysfunction). The median and interquartile range of in-stent neointimal volume obstruction was 8.2% (4.7-10.7), of strut coverage was 93.0% (83.2-96.5) and of incomplete apposed struts was 0% (0.0-0.9), respectively. At three months, the mean angiographic in-stent late lumen loss was 0.17±0.27 mm. No case of stent thrombosis, cardiac death or clinically indicated target lesion revascularisation was reported at three months. Conclusions: Polymer-free sirolimus-eluting stents with a nano-sized-pore surface are effective in inhibiting neointimal tissue proliferation and promoting early vascular healing with high strut coverage at threemonth follow-up. (ClinicalTrials.gov number: NCT01925027).