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Onyx stent meets DAPT performance goal in bleeding-risk patients

Key clinical point: Patients with a high bleeding risk could safely receive dual-antiplatelet therapy for just 1 month following placement of Onyx coronary stents.

Major finding: Cardiac death or MI occurred in 7.0% of patients in months 1-12, a statistically significant difference below the 9.7% performance goal.

Study details: Onyx ONE Clear, a single-arm, multicenter study with 1,506 patients.

Disclosures: Onyx ONE and Onyx ONE Clear were sponsored by Medtronic. Dr. Kirtane’s institution has received research support from Medtronic, and from Abbott Vascular, Abiomed, Boston Scientific, Cathworks, CSI, Philips, ReCor Medical, and Siemens.

Commentary

Nearly one third of patients treated with percutaneous coronary intervention (PCI) are considered to be at high bleeding risk, and shorter duration of dual antiplatelet therapy (DAPT) remains am important question for current generation of stents. Onyx ONE Clear Study was a prospective, multicenter, single-arm study designed to evaluate the safety of one-month DAPT for ~1,500 patients at high risk of bleeding treated with a polymer–based zotarolimus-eluting stent (Resolute Onyx DES). The Onyx ONE Clear study’s primary composite endpoint of cardiac death or myocardial infarction was 7.0%, beating the pre-specified performance goal of 9.7% at one-year post-procedure based on short-DAPT studies. Furthermore, the rate of stent thrombosis was low at 0.7% at one year. This study is the largest study of 1-month DAPT for commercially available DES in the U.S. Findings from this study will provide evidence to guide clinical decisions for high bleeding risk patients and potentially impact future DAPT indications for Onyx DES.”

Luke Kim, MD

Weill Cornell Medical College/New York Presbyterian Hospital

Citation:

Kirtane AJ et al. ACC 2020, Abstract 903-06.