The Onyx ONE Study, a randomized controlled trial with Resolute Onyx in one month dual antiplatelet therapy (DAPT) for high-bleeding risk patients, is a multi-centric clinical trial started in November 2017. The patients (estimated enrollment: 2,000 participants at approximately 70 sites worldwide) will be randomly allocated to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent, using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
Designed to evaluate clinical dual antiplatelet therapy outcomes between two drug eluting stents for the first time ever, the Onyx ONE Study intends to help inform DAPT guidelines for newer-generation drug-eluting stents that currently favour bare-metal stents (BMS) for patients with stable ischaemic heart disease who might require a shorter dual antiplatelet regimen.
In Italy, the recruiting center is San Raffaele Scientific Institute, but first patient was enrolled yesterday, February 13th, at Centro Cardiologico Monzino, by the équipe of Interventional Cardiology 4 OU, headed by Dr. Franco Fabbiocchi.
As previously showed, in patients with high risk of bleeding drug-eluting systems could be a better alternative to bare-metal stents. The present study addresses the critical question whether newer generation durable-polymer drug-eluting stets, like Resolute Onyx, that have demonstrated excellent procedural success in addition to sustained long-term safety and efficacy, could potentially improve results even further among these patients.
Stents from the Resolute DES (drug-eluting stent) family have been implanted in more than six million patients around the world, one million of whom implanted with the latest-generation Resolute Onyx DES. It uses a polymer specifically designed for DES, that features a unique hydrophilic and hydrophobic blend, allowing rapid endothelial healing with minimal inflammation and low risk of stent thrombosis.
- ClinicalTrials.gov. A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (Onyx ONE) https://clinicaltrials.gov/ct2/show/NCT03344653