OrbusNeich has announced that 12-month follow-up data from a post-hoc analysis of the e-HEALING registry has revealed that its Genous stent achieved good and comparable clinical and safety outcomes in patients discontinuing dual antiplatelet therapy at 30 days and at six months.
Genous is the company's patented endothelial progenitor cell capture technology, which accelerates the natural healing of a vessel wall after the implantation of a blood-contact device such as a stent.
The technology constitutes an antibody surface coating that attracts endothelial progenitor cells circulating in the blood to form an endothelial layer. This provides protection against thrombosis and modulates restenosis.
The study evaluated patient outcomes from e-HEALING, a multicentre and worldwide prospective clinical registry that involved 4,939 patients with at least one lesion suitable for non-urgent percutaneous coronary intervention and Genous stent implantation.
In the trial, patients were examined according to continuation or discontinuation of dual antiplatelet therapy after 30-days and 6-months, with each landmark comprising a new baseline. The outcomes were evaluated up to 12 months following stent placement.
The data demonstrated that target vessel failure was 6.5% in patients continuing dual antiplatelet therapy at 30 days, compared with 6.3% in patients who stopped at 30 days
Target vessel failure was 2.4% in patients continuing the therapy at six months, compared with 2.9% in patients who stopped at six months.
Professor Peter Damman of the Academic Medical Center in Amsterdam, the Netherlands, said that studies have demonstrated that the early discontinuation of dual antiplatelet therapy after the placement of a drug-eluting stent is associated with higher rates of stent thrombosis.
"These results reaffirm the safety and efficacy of the Genous stent when accompanied by only one month of dual antiplatelet therapy and support the use of Genous as an alternative to drug-eluting stents in cases where dual antiplatelet therapy may need to be stopped early after stenting," Damman said.