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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synergy | Experimental | Biodegradable-polymer everolimus-eluting stent Synergy |
|
| Xience | Active Comparator | Durable-polymer everolimus-eluting stent Xience |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synergy | Device | Biodegradable-polymer everolimus-eluting stent Synergy |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokorozawa Heart Center | Tokorozawa | 3591142 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41405905 | Derived | Haner JD, Kakizaki R, Taniwaki M, Ohno Y, Yahagi K, Higuchi Y, Siontis GCM, Ando K, Stortecky S, Suzuki N, Watanabe N, Lanz J, Ueki Y, Otsuka T, Biccire FG, Sakurada M, Koskinas KC, Losdat S, Raber L. Low-Density Lipoprotein Cholesterol Levels and Neoatherosclerosis After STEMI: A Secondary Analysis of the CONNECT Randomized Clinical Trial. JAMA Cardiol. 2026 Feb 1;11(2):137-146. doi: 10.1001/jamacardio.2025.4723. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Xience |
| Device |
Durable-polymer everolimus-eluting stent Xience |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |