Optimal Duration of DAPT Following Treatment with Endeavor (Zotarolimus-Eluting Stent) in Real-World Japanese Patients: A Prospective Multicenter Registry
- Conditions
- Coronary artery disease
- Registration Number
- JPRN-UMIN000005476
- Lead Sponsor
- PO Associations for Establishment of Evidence in Interventions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 2400
Not provided
Clinical exclusion criteria: 1.Patient over age 85 2.Patient with ST elevation MI who requires primary or rescue PCI and whose performance status falls under any of the exclusion criteria 3.Patient with cardiogenic shock 4.Patient who underwent stent treatment with BMS in other lesions within 6 months prior to the conduct of index PCI of the target vessel 5.Patient who has undergone some treatment with DES for coronary lesions 6.Patient who is scheduled to undergo elective surgery within 12 months after index PCI 7.Patient whose left ventricular ejection fraction (LVEF) is < 40% 8.Patient with a hemorrhagic predisposition or a history of coagulation abnormality 9.Patient in whom the total number of deployed stents exceeds 4, regardless of the number of lesions and the number of affected branches 10.Patient with a verified history of CVA before stenting 11.Patient with a verified history of active peptic ulcer or upper gastrointestinal tract bleeding before stenting 12.Patient showing impaired renal function (serum creatinine concentration: > 1.8 mg/dL) 13.Patient with known contraindications for aspirin or clopidogrel (the physician should assess tolerability within the range of routine medical care) 14.Patient with a known disorder who has a life expectancy of less than 12 months 15.Patient who is incompetent to adhere to all clinical FUs listed in the present protocol. Angiographic exclusion criteria: 1.Lesions located within the saphenous venin graft (SVG) 2.Unprotected lesions in the left coronary trunk 3.Lesions of in-stent restenosis in previously deployed DES or BMS 4.Lesions with an anatomical structure of the coronary artery that is not eligible for treatment by the deployment of Endeavor ZES
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of NACCE at clinical FU at month 12 after stenting. NACCE: NACCE is defined as a composite endpoint consisting of death from some causes (including cardiac death and noncardiac death), MI (including Q-wave MI and non-Q-wave MI), CVA, and major bleeding (as per the definitions listed in the revised version of REPLACE and in GUSTO).
- Secondary Outcome Measures
Name Time Method 1.Incidence of ST as per the definition by ARC 2.Durations of TVR and TLR at months 9 and 12 after stenting 3.Incidence of MACE at months 1, 3, 6, 9, and 12 after stenting 4.Duration of DAPT and patient compliance 5.Incidence of hemorrhagic complications (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding) MACE: MACE is defined as a composite endpoint consisting of cardiac death from some causes (including cardiac and noncardiac death), MI (Q-wave MI and non-Q wave MI), TLR, and coronary artery bypass graft (CABG).