Coronary Artery Disease
Conditions
Brief summary
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older
Detailed description
For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy
Interventions
DEVICEOnyx family
Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents
Sponsors
Pusan National University Yangsan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Aged 75 or more. * Eligible for interventional procedures. * Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%. * Able to take antiplatelets for at least 1 months after the procedure. * Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.
Exclusion criteria
* The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[eg, rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled). * Patients with active pathologic bleeding. * Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. * History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia). * Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment). * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE at 12 months after coronary artery intervention | 1 year after the procedure | MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of procedures | 1 year after the procedure | All-cause mortality |
Countries
South Korea
Contacts
Primary ContactMin Ku Chon, MD,PhD
Outcome results
None listed