Medtronic has received the CE mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent. A press release reports that for high bleeding risk patients, this new, first-of-its-kind indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx.
The press release adds that the approval is the first of its kind globally. Resolute Onyx is available for use in the USA, as well as in Europe and other countries that recognise the CE mark. It is not currently indicated for high bleeding risk patients with one-month DAPT in the USA, but data have been submitted to the US Food and Drug Administration (FDA) with the intent of obtaining a one-month DAPT US indication for Resolute Onyx.
The indication is based on results from the Onyx ONE Global Study, the first prospective, randomised, one-month DAPT trial comparing Resolute Onyx to a competitive drug-eluting stent (BioFreedom drug-coated stent, Biosensors) in nearly 2,000 high bleeding risk patients. In the study, Resolute Onyx met its primary composite endpoint of cardiac death, myocardial infarction or stent thrombosis at one-year showing non-inferiority versus BioFreedom drug-coated stent. Results from the global study were shared during a late-breaking clinical trial session at 2019 Transcatheter Cardiovascular Therapeutics (TCT) conference and were also published in the New England Journal of Medicine.
Azeem Latib (Montefiore Medical Center, New York City, USA) comments: “The use of DAPT for drug-eluting stents is a challenge for high bleeding risk patients who may not be able to safely tolerate the same therapy duration as recommended for the broader patient population. Through the Onyx ONE global clinical programme, we have observed that Resolute Onyx drug-eluting stent with one-month of DAPT in these complex patients is safe and effective. This indication will further substantiate the option for shorter DAPT regimens, if individual patient needs demand it.”
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, states: “The growing body of clinical evidence supports the use of Resolute Onyx to meet the needs of complex patient populations. Resolute Onyx has shown exceptional outcomes in complex patient populations and anatomies, including those at a high risk of bleeding, which has helped pave the way for this first-of-its-kind approval.”
The press release states that the Onyx ONE Global Study, together with the Onyx ONE Clear Study—a study that evaluated Resolute Onyx DES in high bleeding risk patients with one-month DAPT in the USA and Japan—make up the robust Medtronic Onyx ONE Month DAPT programme that has enrolled approximately 2,700 patients at up to 130 sites worldwide. To date, more than 22,000 patients have been studied in Medtronic sponsored and funded clinical trials that have addressed DAPT duration.