June 5, 2020
CE Mark Approved for 1-Month DAPT Indication for High Bleeding Risk Patients Treated With Medtronic’s Resolute Onyx DES
June 5, 2020—Medtronic announced it has received European CE Mark approval for a 1-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES).
Resolute Onyx DES, with the new indication, is available in Europe and other countries that recognize the CE Mark. In the United States, the Resolute Onyx DES is available for use but is not currently indicated for HBR patients with 1-month DAPT. Data have been submitted to the FDA with the intent of obtaining approval for the 1-month DAPT indication for Resolute Onyx DES.
According to the company, the indication is based on results from the Onyx ONE global study, a prospective, randomized, 1-month DAPT trial comparing Resolute Onyx with the polymer-free, BioFreedom BA9 drug-coated stent (Biosensors International Group, Ltd.) in approximately 2,000 HBR patients. Resolute Onyx met its primary composite endpoint of cardiac death, myocardial infarction, or stent thrombosis at 1-year, showing noninferiority versus BioFreedom.
Results from the global study were presented by Stephan Windecker, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25-29 in San Francisco, California. Dr. Windecker, et al published the findings in The New England Journal of Medicine (2020; 382:1208-1218).
“The use of DAPT for DES is a challenge for HBR patients who may not be able to safely tolerate the same therapy duration as recommended for the broader patient population,” commented Azeem Latib, MD, in Medtronic’s announcement. “Through the Onyx ONE global clinical program, we have observed that Resolute Onyx DES with 1-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.” Dr. Latib is Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York, New York.