The FDA has cleared a new indication for the Medtronic Resolute Onyx Drug Eluting Stent, making it the first DES that only required one month of dual antiplatelet therapy (DAPT) in patients who are considered high risk for bleeding complications.
October 1, 2020 — Medtronic has received U.S. Food and Drug Administration (FDA) approval for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx Drug Eluting Stent (DES). The Resolute Onyx DES is the first-and-only DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT – the combination of aspirin and an anti-clotting medication – following a percutaneous coronary intervention (PCI) in patients at high bleeding risk.
Patients that are at risk for high bleeding include older patients, those with history of bleeding, or those on oral blood-thinning drugs, and account for up to 40 percent of PCI patients. Clinical studies have demonstrated that Resolute Onyx DES and its biocompatible polymer and stent design promote fast vessel healing and is well-suited for patients who may benefit from a DAPT duration as short as one month.
"It is so rewarding to see the efforts of those involved in examining the safety and efficacy of one-month of DAPT following PCI – the coordinators, investigators and most importantly the Onyx One Clear patient participants – come to fruition with this new high bleeding risk indication for the Resolute Onyx drug eluting stent," said Ajay Kirtane, M.D., professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and principal investigator for the Onyx One Clear study. "It is remarkable how the combination of technology innovation, in conjunction with the generation of clinical evidence, has informed our understanding that shorter durations of DAPT may in fact be safe in appropriately selected patients treated with Resolute Onyx DES."
Using a broad criteria for HBR, the approval is based on results from the Onyx ONE Clear Study that evaluated approximately 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx. At one year, the study met its primary endpoint of cardiac death or myocardial infarction and showed Resolute Onyx to be safe and effective in HBR patients on one-month DAPT. Results from the study were shared virtually in March 2020 at the American College of Cardiology together with the World Congress of Cardiology Scientific Sessions (ACC.20/WCC). The Onyx ONE Clear study, coupled with the Onyx ONE Global study, make up the Onyx ONE Month DAPT Program that supports the advancement of DAPT evidence, initiated by physicians and Medtronic.
"The journey leading to an HBR indication has included years of rigorous clinical evaluation with more than 22,000 complex patients studied," said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. "We're excited to realize our goal of providing physicians with more robust data and a supporting indication to inform treatment decisions for HBR patients, who may be suitable for a one-month course of DAPT."
In May, the Resolute Onyx was the first DES to receive CE Mark for a one-month DAPT indication for patients at high bleeding risk in Europe.
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Related Content on DES With Shortened DAPT:
VIDEO: Overview of Short DAPT in High-risk Bleeding Patients Who Receive Stents — Interview with Robert Harrington, M.D.
VIDEO: Early Discontinuation of DAPT in High Bleeding Risk Patients With the Synergy Stent. — Interview with Ajay Kirtane, M.D.
VIDEO: TWILIGHT Trial Shows Benefit to Ticagrelor Monotherapy After Stent Implantation — Interview with Roxana Mehran, M.D.
6 Hot Topics in Interventional Cardiology at TCT 2019
Resolute Onyx Drug-Eluting Stent Noninferior to Polymer-Free Drug-Coated Stent With One-Month DAPT
Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
TWILIGHT Trial Substudy Examines Bioabsorbable Polymer vs. Durable Polymer Drug-Eluting Stents in High-Risk PCI
1. Windecker S, Latib A, Kedhi E, et al. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020; 382:1208-1218.doi: 10.1056/NEJMoa1910021.
2. Roleder T, Kedhi E, Berta B, et al. Short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: Onyx one-month optical coherence tomography study. Adv Interv Cardiol. 2019;15(2):14-150.