A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI

Study Overview
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Brief Summary
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This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and uncovered stent struts at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.

Detailed Description
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DES use has significantly improved clinical outcomes as compared with bare metal stents (BMS), primarily through a notable reduction in the risk of repeat revascularisation. However, durable polymer DES have been associated with an increased risk of late and very late stent thrombosis and the anticipated development of in-stent neoatherosclerosis. In addition, in-vivo study suggest that different types of polymer among current DES might have different responses to acute thrombogenecity after stent implantation. Patients with STEMI are associated with worse long-term clinical outcomes due to re-infarction and stent thrombosis throughout long-term follow-up. Underlying unstable lesion which includes ruptured plaque and thin-cap fibroatheroma behind stent strut is a predictor of neoatherosclerosis formation. There is no dedicated randomized trial to comparing biodegradable-polymer versus durable polymer-DES in terms of acute thrombogenecity and long-term healing at 3 years after primary PCI. Therefore this study is designed to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.

Official Title
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A Randomized COmparison of LoNg-Term Vascular HealiNg bEtween Biodegradable -Polymer (BP) Versus Durable Polymer (DP) Everolimus Eluting Stents in Acute ST-Elevation Myocardial InfarCTion

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Synergy
* Device: Xience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Primary PCI within 24 hours of symptom onset ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads 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 Exclusion Criteria: Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material Inability to understand and provide informed consent Currently participating in another trial before reaching first endpoint Mechanical complications of acute myocardial infarction Acute myocardial infarction secondary to stent thrombosis or restenosis Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance History of bleeding diathesis or known coagulopathy Use of oral anticoagulation Age >90 years LV-function at index procedure <=20% Cancer under active treatment (chemotherapy) Hemodynamic instability following primary PCI Chronic kidey disease (Creatinine - Clearance < 30ml/min) OCT technically not feasible (severe calcification, tortuosity)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synergy<br>Biodegradable-polymer everolimus-eluting stent Synergy | Device: Synergy<br>* Biodegradable-polymer everolimus-eluting stent Synergy<br>Device: Xience<br>* Durable-polymer everolimus-eluting stent Xience<br>|
| Active Comparator: Xience<br>Durable-polymer everolimus-eluting stent Xience | Device: Synergy<br>* Biodegradable-polymer everolimus-eluting stent Synergy<br>Device: Xience<br>* Durable-polymer everolimus-eluting stent Xience<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of neoatheroslcerosis | Frequency of neoatherosclerosis lesion 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 ≧ 1 mm at three years. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Athero-thrombotic material area | Athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI | initial day |