Patients with acute myocardial infarction undergoing percutaneous coronary intervention ischemic heart disease
Conditions
Interventions
Synergy: everolimus-eluting stent with biodegradable polymer (Boston Scientific, Marlborough, USA)
Sponsors
Taniwaki Masanori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years 2. Primary PCI within 24 hours of symptom onset 3. ST-segment elevation of greater than or equal to 1mm in at least 2 contiguous leads, or (presumably new) left bundle branch block or true posterior MI with ST depression of greater than or equal to 1mm in at least 2 contiguous anterior leads 4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents 5. Signed informed consent
Exclusion criteria
Exclusion criteria: 1.Female of childbearing potential (age less than 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. 2. Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, biolimus or contrast material 3. Inability to provide informed consent 4. Currently participating in another trial before reaching first endpoint 5. Mechanical complications of acute myocardial infarction 6. Acute myocardial infarction secondary to stent thrombosis or restenosis 7. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period 8. Noncardiac comorbid conditions are present with life expectancy less than 3 years or that may result in protocol noncompliance 9. History of bleeding diathesis or known coagulopathy 10. Use of oral anticoagulation 11. Age greater than or equal to 90 years 12. LV-function at index procedure less than or equal to 20% 13. Cancer under active treatment (chemotherapy) 14. Hemodynamic instability following primary PCI 15. Chronic kidney disease (estimated creatinine clearance less than 30ml/min) 16. OCT technically not feasible (severe calcification, tortuosity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of neoatherosclerosis which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of greater than or equal to 1 mm in optical coherence tomography (OCT) at 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Athero-thrombotic material area (tissue protrusion plus isolated intraluminal defect) within the stent struts after primary PCI 2. Clinical endpoints throughout 3 years Clinically and non-clinically indicated target lesion revascularization (TLR) Clinically and non-clinicall indicated target vessel revascularization (TVR) All deaths (cardiac and non-cardiac) Myocardial infarction (Q-wave and NQWMI) Stent thrombosis rate defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition) 3. Angiographic endpoints throughout 3 years In-stent and in-segment binary restenosis rate In-stent and in-segment minimal luminal diameter (MLD) In-stent and segment percent diameter stenosis In-stent and in-segment late luminal loss 4. OCT-derived endpoints throughout 3 years Percentage of neoatherosclerosis Percentage of fibroatheroma (thin cap fibroatheroma, thick cap fibroatheroma) Percentage of fibrocalcific plaque Percentage of macrophage Percentage of uncovered struts Percentage of malapposed struts Percentage of lesions with malapposed struts Mean area of neointimal hyperplasia Neointimal hyperplasia volume Percent neointimal hyperplasia obstruction Descriptive Analysis of morphometric, lesion composition and stent strut data | — |
Contacts
Public ContactMasanori Taniwaki
Mitsui Memorial Hospital
Outcome results
None listed