NCT03440801

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Tokorozawa Heart Center · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• STEMI - ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Synergy	Biodegradable-polymer everolimus-eluting stent Synergy
DEVICE	Xience	Durable-polymer everolimus-eluting stent Xience

Timeline

• Start date: 2017-07-03
• Primary completion: 2024-07-30
• Completion: 2024-09-01
• First posted: 2018-02-22
• Last updated: 2025-09-08

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study