OrbusNeich touted pooled data from two registries evaluating its dual-therapy stent this week at the annual meeting of the American College of Cardiology.
The Combo stent was implanted in more than 3,600 all-comer patients and followed by researchers for one year. The registries found that the device was safe and effective after one year, featuring a low stent thrombosis rate of 0.8% and a 3.9% rate of major cardiac event at one year.
Researchers presenting the data at ACC ’18 noted that these results, while promising, need to be further examined in a randomized, controlled clinical trial and compared to other drug-eluting stents, according to reports from MedScape.
OrbusNeich’s Combo stent, which combines sirolimus and a layer of antibodies designed to capture endothelial progenitor cells, won CE Mark clearance in the European Union in 2013.
The study presented at ACC ’18 combined data from 1,000 patients in the Remedee registry who received the device between 2013 and 2014, as well as 2,624 patients in the Mascot registry who were implanted with the device between 2014 and 2016.
Researchers reported observing target lesion failure in 3.9% of patients. Of the 140 patients who experienced TLF, 1.6% died from cardiac causes, 1.2% had target vessel MI and 2.2% had target lesion revascularization, MedScape reported.
At last year’s Transcatheter Cardiovascular Therapeutics meeting, OrbusNeich and Medtronic presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent.
In OrbusNeich’s study, investigators hypothesized that they could reduce the duration of DAPT by using the company’s Combo dual therapy stent.
The study enrolled 1,496 patients with acute coronary syndrome and treated them with the Combo dual therapy stent and either three months or 12 months of DAPT. The trial’s primary endpoint was a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target-vessel revascularization and bleeding at 12 months.
There was no difference in the primary endpoint between three and 12 months DAPT, the company reported, and bleeding rates were similar among both treatment groups.