OrbusNeich reports data from Combo stent’s trial for coronary syndrome

6 November 2017 (Last Updated November 6th, 2017 12:18)

Hong Kong-based firm OrbusNeich has reported positive results from the REDUCE trial of its dual therapy stent, Combo, in patients with acute coronary syndrome (ACS).

Hong Kong-based firm OrbusNeich has reported positive results from the REDUCE trial of its dual therapy stent, Combo, in patients with acute coronary syndrome (ACS).

The results compare the efficacy of the stent at a short-term period of three months with 12-month dual antiplatelet therapy (DAPT).

Combo is designed to repair vessel injury and regenerate endothelium to aid in the natural healing of vessels by enhancing endothelial coverage and control of neointimal proliferation.

The dual therapy stent combines the firm’s endothelial progenitor cell (EPC) capture technology with the delivery of a sirolimus drug elution from a bioresorbable polymer that degrades in 90 days.

As per the data, the stent demonstrated non-inferiority with no difference in the primary endpoint between three and 12 months DAPT in the intent to treat (ITT) population.

Based on the CURE trial performed 20 years ago, current guidelines require continuation of a DAPT therapy using a first-generation drug-eluting stent (DES) for 12 months.

“REDUCE showed 8.3% overall incidence of the primary endpoint event compared to 12% in other trials.”

The physician-initiated, prospective, multi-centre, randomised REDUCE trial is designed to procure evidence for a different DAPT regimen and new-generation stent.

Conducted in 1,496 subjects at 36 hospitals in Europe and Asia, REDUCE measured primary clinical endpoint as a composite of all-cause mortality, all myocardial infarction, stent thrombosis, stroke, target vessel, revascularisation and moderate or severe bleeding within 360 days after randomisation.

REDUCE showed 8.3% overall incidence of the primary endpoint event compared to 12% in other trials.

The results were found to be consistent across all subgroups without any interaction that was statistically significant.

Clinical follow-ups carried out at three, six months and one year are scheduled to continue for two years post-randomisation.