Onyx 1-Month OCT Study Investigates DAPT Duration in Complex Patients After Stent Implantation
May 24, 2018—Medtronic announced that clinical data from the independently run Onyx 1-Month OCT study were presented at EuroPCR 2018, held May 21-25 in Paris, France. Data from 15 patients, including 13 with acute coronary syndrome, were evaluated using optical coherence tomography (OCT).
According to the company, the data showed strong early vessel healing in a patient population that included a high percentage of patients with complex coronary artery disease who were implanted with Medtronic's Resolute Onyx drug-eluting stent (DES) at 1-month follow-up. Patients implanted with the Resolute Onyx DES demonstrated an excellent early healing profile, with an average of 88% of struts covered by neointimal formation and 92.3% of the total stented area showing complete strut coverage at 1 month, which includes the covered areas in between the struts.
The Resolute Onyx DES received European CE Mark approval in September 2014 and US Food and Drug Administration approval in April 2017, advised Medtronic.
Elvin Kedhi, MD, commented in the company's press release, “The signal of early healing is crucial for patients who may need to interrupt or discontinue dual antiplatelet 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.” Dr. Kedhi, who is one of the principal investigators of the Onyx 1-Month OCT study, is an interventional cardiologist at Isala Hartcentrum in Zwolle, the Netherlands.
Medtronic also announced that in a separate analysis presented at the EuroPCR meeting, new data from the DAPT-STEMI trial in patients treated with Medtronic's Resolute Integrity DES showed excellent results in a prospective prespecified registry, which evaluated all patients after 6 months of DAPT before randomization. At 6 months, the patient-oriented composite primary endpoint (all-cause mortality, any myocardial infarction, any revascularization, stroke, and TIMI [thrombolysis in myocardial infarction] major bleeding) occurred in 4.2% of patients, with low rates of target lesion revascularization (1.1%) and stent thrombosis (0.7%).