Investigators unveiled clinical data from the independently run Onyx 1-Month OCT Study, which showed strong early vessel healing in a patient population that contained a high percentage of patients with complex coronary artery disease who were implanted with the Resolute Onyx drug-eluting stent at one-month follow-up. Presented at the EuroPCR (22 May–25 May, Paris, France), data from 15 patients—including 13 with acute coronary syndrome—were evaluated using optical coherence tomography (OCT).
In the Onyx 1-Month OCT study, according to a press release, patients implanted with the Resolute Onyx drug-eluting stent demonstrated an excellent early healing profile with an average of 88% of struts covered by neointimal formation (new cell growth over stent struts. Also, 92.3% of the total stented area showing complete strut coverage at one month, which includes the covered areas in between the struts.
Elvin Kedhi (Isala Hartcentrum, Zwolle, the Netherlands), one of the lead principal investigators of the Onyx 1-Month OCT study, comments: “The signal of early healing is crucial for patients who may need to interrupt or discontinue dual anti-platelet therapy (DAPT) within a short period of time after receiving a stent. These data help expand the growing body of clinical evidence that may support physicians in tailoring DAPT regimens for complex patients.”
The Onyx 1-Month OCT Study is the latest of several Medtronic-funded studies helping to generate additional clinical evidence to reinforce the understanding of healing and shorter DAPT regimens in complex patients. Last year, Medtronic announced the Onyx ONE Global Study, a randomised clinical trial that will compare one-month DAPT between two drug-eluting stents for the first time, which is currently enrolling. A similar study will launch in the USA and Japan later this calendar year and will help inform DAPT guidelines for newer-generation drug-eluting stents that currently favour bare-metal stents for patients at an increased risk of bleeding who might require a shorter DAPT regimen.