OrbusNeich has announced that new clinical data presented at 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium show durable outcomes as well as excellent early healing and optimal neointimal suppression out to 24 months following placement of the Combo dual therapy stent.
These results from the EGO-COMBO study were presented by Stephen WL Lee of the Queen Mary Hospital, University of Hong Kong, China.
In a press release it states that the study was the first of its kind to assess the healing profile of a drug-eluting stent by longitudinal sequential optical coherence tomography (OCT) and uniquely showed an improvement in outcomes (neointimal regression) between nine and 24 months in terms of neointimal volume, neointimal thickness and plaque volume.
Between nine and 24 month OCT follow-up, patients exhibited an 11.3% decrease in neointimal volume, from 35.5mm3 [30.7-40.3] to 31.5mm3 [26.9-36.2] (p<0.001); a 4.5% decrease in neointiminal thickness, from 0.156mm [0.143-0.168] to 0.149 [0.136-0.161] (p=0.19); and a 9.7% decrease in in-stent percentage neointimal volume, from 17.5% [16.0-19.0] to 15.8% [14.5-17.1] (p=0.002), for the Combo stent. No further stent thrombosis, neoatherosclerosis or clinically driven target lesion revascularisation were observed.
“We previously reported nine-month results from EGO-COMBO that established the impressive early healing profile of the Combo stent,” Lee says. “These 24-month results now demonstrate the Combo stent’s excellent durability over the long-term with a trend of neointima regression observed by OCT. This is the first time ever for a drug-eluting stent reported in the market.”
In the study, 61 patients received 88 Combo stents with a mean diameter of 3.06±0.39mm and a mean length of 23.9±7.62mm. OCT was performed at baseline, at early follow-up (before five months) and at nine months in all patients. The clinical follow-up was carried out to 12 months. Per the extension study protocol, 59 patients were evaluated clinically at 24 months, and, of those, 41 agreed to have a restudy by OCT. All patients received dual antiplatelet therapy (DAPT) for nine months.
The clinical event adjudications, quantitative coronary angiography and OCT analyses were performed by the Cardiovascular Research Foundation Core Lab in New York, USA.