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Onyx ONE Clear Study

Evaluating Resolute Onyx™ DES in high bleeding risk patients with one month of DAPT in the United States and Japan.

SEE WHAT'S NEXT
Onyx ONE Clear Study Results at ACC.20
Presented by Dr. Ajay Kirtane
March 29 at 8:25 a.m.

Medtronic is committed to developing additional evidence to help guide dual antiplatelet therapy treatment decisions, which are best made on an individual basis and should integrate current guidelines, clinical judgement, assessment of the benefit/risk ratio, and patient preference. Resolute Onyx DES is not currently indicated for high bleeding risk patients on one-month DAPT. 

PROSPECTIVE, MULTICENTER, SINGLE-ARM
1-MONTH DAPT CLINICAL TRIAL
IN HIGH BLEEDING RISK PATIENTS

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DAPT DURATION:
DAPT mandated for 1 month, followed by long-term SAPT

PRIMARY ENDPOINTS:
Composite of cardiac death, myocardial infarction (MI) at
one year for a one-month clear population.

SECONDARY ENDPOINT:
Acute success, all deaths, MACE, target vessel failure, target lesion failure, revascularizations, stent thrombosis, stroke, bleeding per BARC criteria; at all follow-up time points (1, 2, 6 months, 1 and 2 years), except acute success

COORDINATING INVESTIGATORS:
Ajay Kirtane, David Kandzari

HIGH BLEEDING RISK PATIENTS:(N = 800); 55 CENTERS; CLINICAL TRIAL LOCATIONS: United States, Japan
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Additional patients (up to 100) may be enrolled in Japan.

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 Onyx DES is not currently indicated for high bleeding risk patients on one-month DAPT. 

ClinicalTrials.gov identifier:  NCT03647475