A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

Conditions

Coronary Artery Disease

Brief summary

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Kang J, Abdul Ghapar AK, Selvaraj K, Hur SH, Tam CC, Jang Y, Chae IH, Kandzari DE, Kirtane AJ, Latib A, Kedhi E, Lung TH, You SJ, Windecker S, Stone GW, Kim HS.

2024-07-061 citations

10.1253/circrep.cr-24-0037

Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging.

Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D.

2023-07-241 citations

10.1016/j.carrev.2023.07.016

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

David E. Kandzari, Ajay J. Kirtane, Stephan Windecker, Azeem Latib, Elvin Kedhi et al. (25 authors)

Circulation Cardiovascular Interventions2020-11-0165 citations

10.1161/circinterventions.120.009565

Interventions

COMBINATION_PRODUCTDevice: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below: * Adjunctive chronic oral anticoagulation treatment planned to continue after PCI * Age ≥ 75 years old * Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure) * Any prior documented intracerebral bleed * Any documented stroke in the last 12 months * Hospital admission for bleeding during the prior 12 months * Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment) * Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI * Planned surgery that would require interruption of DAPT (within the next 12 months) * Renal failure defined as: Creatinine clearance \<40 ml/min * Thrombocytopenia (PLT \<100,000/mm3) * Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice * Expected non-compliance for at least 6 months DAPT for other medical reasons

Exclusion criteria

* Pregnant and breastfeeding women * Subjects requiring a planned PCI procedure after 1 month of index procedure * Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy * Active bleeding at the time of inclusion * Cardiogenic shock * Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure * Subject not expected to comply with long-term single antiplatelet therapy * A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated. * PCI during the previous 6 months for a lesion other than the target lesion of the index procedure * Participation in another clinical study within 12 months after index procedure * Subjects with life expectancy of less than 2 years

Design outcomes

Primary

Measure	Time frame	Description
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction	One Month to one year	Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]

Secondary

Measure	Time frame	Description
Number of Participants With Procedure Success	Procedure to hospital discharge, an average of 1.3 days	Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
All Participants Deaths Including Cardiac Death	One Month to One Year	All participants deaths including cardiac death
Number of Patients With Major Cardiac Event	One Month to One Year	Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Number of Patients With Myocardial Infarction	One Month to One Year	All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Number of Patients With Target Vessel Failure	One Month to One Year	Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
Number of Participants With Target Lesion Failure	One Month to One Year	Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical method
Number of Patients With Stent Thrombosis	One Month to One Year	Stent thrombosis (per Academic Research Consortium (ARC) definition)
Number of Patients With Bleeding	One Month to One Year	Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe. Grouping of BARC categories: * BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories * BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories * All BARC- This included all bleeding events BARC 1 through BARC 5
Number of Patients With Stroke	One Month to One Year	Stroke
Lesion Success	End of Procedure, an average of 42 minutes	The attainment of \<30% residual stenosis by QCA (or \< 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Device Success	End of Procedure an average of 42 minutes	Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Number of Patients With Revascularization	One Month to One Year	All revascularizations (TLR, TVR and non-TVR)

Countries

United States

Participant flow

Pre-assignment details

Per protocol, the 752 subjects enrolled in the US & Japan were pooled with A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (NCT03344653). Subjects enrolled under NCT03344653 were in regions outside of the US and Japan.

Participants by arm

Arm	Count
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.	1,506
Total	1,506

Arm

Count

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent

Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

1,506

Total

1,506

Baseline characteristics

Characteristic	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	1265 Participants	—
Age, Categorical Between 18 and 65 years	241 Participants	—
Age, Continuous	74 years STANDARD_DEVIATION 9.5	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Australia	85 Participants	—
Region of Enrollment Austria	11 Participants	—
Region of Enrollment Belgium	27 Participants	—
Region of Enrollment Bulgaria	52 Participants	—
Region of Enrollment France	12 Participants	—
Region of Enrollment Hong Kong	20 Participants	—
Region of Enrollment Ireland	27 Participants	—
Region of Enrollment Italy	61 Participants	—
Region of Enrollment Japan	37 Participants	—
Region of Enrollment Latvia	11 Participants	—
Region of Enrollment Lithuania	6 Participants	—
Region of Enrollment Malaysia	100 Participants	—
Region of Enrollment Netherlands	50 Participants	—
Region of Enrollment New Zealand	33 Participants	—
Region of Enrollment Norway	2 Participants	—
Region of Enrollment Poland	23 Participants	—
Region of Enrollment Singapore	8 Participants	—
Region of Enrollment Slovakia	92 Participants	—
Region of Enrollment South Korea	106 Participants	—
Region of Enrollment Spain	98 Participants	—
Region of Enrollment Sweden	25 Participants	—
Region of Enrollment Switzerland	12 Participants	—
Region of Enrollment Thailand	1 Participants	—
Region of Enrollment United Kingdom	43 Participants	—
Region of Enrollment United States	564 Participants	—
Sex: Female, Male Female	487 Participants	—
Sex: Female, Male Male	1019 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	89 / 1,506
other Total, other adverse events	755 / 1,506
serious Total, serious adverse events	591 / 1,506

Outcome results

Primary

Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction

Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]

Time frame: One Month to one year