Drug-eluting stent and Onyx ONE 1-month DAPT program

Robust clinical program evaluating Resolute Onyx
DES in high bleeding risk
patients on 1-month DAPT.

<span style="font-size:34px;line-height:1em;">ONYX ONE<br><strong>MONTH DAPT PROGRAM</strong>


Balancing DAPT guidelines with individual treatment plans can be challenging — the need for DAPT to reduce thrombotic risk following PCI vs. the bleeding risk associated with its prolonged use.

These considerations are especially acute in high bleeding risk patients. That’s where the Onyx ONE Month DAPT Program
comes in.

Our program is studying the safety and efficacy of Resolute Onyx™ DES in high bleeding risk patients on 1-month DAPT — developing additional evidence to help guide DAPT duration decisions.

ONYX ONE GLOBAL STUDY

First-of-its-kind prospective, randomized 1-month DAPT clinical trial in high bleeding risk patients, DES vs. DES.

EXPLORE THE GLOBAL STUDY

ONYX ONE CLEAR STUDY

Prospective, multicenter, single-arm 1-month DAPT clinical trial in high bleeding risk patients.

EXPLORE THE CLEAR STUDY

Discover Resolute Onyx™ DES — the stent behind the studies.

SEE WHAT MAKES IT DIFFERENT
Physician Informing Patient of Onyx ONE 1-Month DAPT Information

Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at Medtronic.com/emanuals for more detailed information on Indications, Contraindications, Warnings, Precautions, and Adverse Events.

Per 2016 ACC/AHA guidelines, a daily aspirin dose of 81 mg is recommended indefinitely after PCI. A P2Y12 platelet inhibitor should be given daily for at least 6 months in stable ischemic heart disease patients and for at least 12 months in patients with acute coronary syndrome (ACS).

Consistent with the DAPT Study, and the 2016 ACC/AHA guidelines, longer duration of DAPT may be considered in patients at higher ischemic risk with lower bleeding risk. In patients at higher risk of bleeding, DAPT discontinuation may be reasonable after 3 months in stable patients or 6 months in ACS patients. Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgment, assessment of the benefit/risk ratio, and patient preference. Resolute DES family should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

Onyx ONE Clear Study Clinicaltrials.gov identifier: NCT03647475
Onyx ONE Global Study Clinicaltrials.gov identifier: NCT03344653

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