OrbusNeich has announced that its Genous stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents in low-risk no stent thrombosis segment elevation acute coronary syndrome patients at six months. Data from JACK-EPC, an investigator-initiated randomised study, were published in Minerva Cardioangiologica.
According to the results, the binary restenosis rate for the Genous stent was 13% compared to 26.6% for bare metal stents at six months. At 12 months, the major adverse cardiac events rate for the Genous stent was 13.3% compared to 23.3% for bare metal stents, and no stent thrombosis was observed in either group.
“In this randomised study, we see that the Genous stent is associated with less neointimal proliferation than a bare metal stent, with significantly lower restenosis and late loss observed,” said Wojciech Wojakowski, of the Medical University of Silesia, Poland, and corresponding author of the publication. “This combined with its favourable safety profile makes Genous an effective alternative to bare metal stents and drug eluting stents for patients with contraindications to dual antiplatelet therapy.”
The study investigated the possible correlation between circulating endothelial progenitor cells (EPCs) and restenosis. Previous studies with the Genous stent as well as drug-eluting stents have shown that lower numbers of these cells might be associated with higher in-stent restenosis and stent thrombosis. The authors noted that the number of circulating EPCs was approximately twofold higher during ACS than at six months and the mobilisation of EPCs during acute ischaemia was significantly lower in patients who developed restenosis after six months (three cells/microlitre vs. 4.5 cells/microlitre).
The investigator-initiated prospective randomised study enrolled 60 patients, randomised 1:1, with NSTE-ACS. The majority in both groups presented with NSTE myocardial infarction: 73.3% in the Genous stent group and 70% in the bare metal stent group. Inclusion criteria included a de novo lesion of greater than 70% in a native coronary artery with a diameter between 2.5mm and 4mm and a lesion length of less than 30mm that could be treated with a single stent. Of all lesions treated, 83% were type B2/C lesions in the Genous stent group and 80% in the bare metal stent group.
The patients received 80mg atorvastatin and dual antiplatelet therapy for 12 months. Restenosis was assessed after six months by quantitative coronary angiography. The number of circulating EPCs that were positive for CD34, CD133 and VEGFR2 were measured with fluorescence-activated cell sorting (FACS) prior to percutaneous coronary intervention and, at six months, in both patients, with and without restenosis. The study’s primary endpoint was binary restenosis. The primary safety endpoint was the composite of major adverse cardiac events including cardiovascular death, reinfarction and hospitalisation for unstable angina at six months.