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March 30, 2020

Medtronic Reports Results From Onyx ONE Clear Study of 1-Month DAPT in High Bleeding-Risk DES Patients

March 30, 2020—Medtronic announced positive results of the Onyx ONE Clear study that evaluated the company's Resolute Onyx drug-eluting stent (DES) in high bleeding-risk (HBR) patients with 1-month dual antiplatelet therapy (DAPT). The study met its primary endpoint of cardiac death or myocardial infarction by beating a performance goal derived from contemporary 1-month DAPT trials at 1-year postprocedure.

Ajay Kirtane, MD, presented the data at ACC.20/WCC Virtual, the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology.

Dr. Kirtane commented in Medtronic's press release, “Despite the high-risk population, we observed a low rate of ischemic outcomes after DAPT discontinuation at 1 month. These data, in conjunction with the randomized data from the Onyx ONE Global randomized controlled trial, offer additional clinical evidence of 1-month of DAPT for appropriately selected patients treated with the Resolute Onyx DES.” Dr. Kirtane, the study's lead investigator, is Professor of Medicine at Columbia University Irving Medical Center in New York, New York.

According to Medtronic, the prospective, multicenter, single-arm Onyx ONE Clear study included highly complex HBR patients in the United States and Japan who were treated with 1-month DAPT after PCI with Resolute Onyx and were clear of any adverse events and were DAPT compliant at 1 month. Patients in the study were pooled with similar patients treated with Resolute Onyx from the Onyx ONE Global study, totaling approximately 1,500 patients that were included in the primary endpoint analysis.

The Onyx ONE Clear study’s primary composite endpoint of cardiac death or myocardial infarction was 7%, beating the prespecified performance goal of 9.7% at 1-year postprocedure. The rate of stent thrombosis was low at 0.7% at 1 year. The performance goal was based on short-DAPT studies.

Medtronic stated that the Onyx ONE Clear study was designed to complement the Onyx ONE Global study. The Onyx ONE Global results were published on March 26 by Stephan Windecker, MD, et al in The New England Journal of Medicine (2020;382:1208–1218). The two studies make up the Medtronic Onyx ONE Month DAPT program that has enrolled approximately 2,700 patients at up to 130 sites worldwide.

The Resolute Onyx DES was approved in the United States in 2017. It is not currently indicated for HBR patients on 1-month DAPT, advised Medtronic.

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